The first of its kind in the world, the professional Doctor of Regulatory Science (DRSc) program (a blended program that allows online participation) cultivates research, leadership and inquiry skills in advanced students who want to operate at the pinnacle of the field globally.
Through the program, students will gain experience in strategic management, policy development, research assessment and preparation to work in senior positions in the public sector, academia and life sciences industry.
Instead of a traditional doctor of philosophy, the DRSc gives graduates the potential and background for careers in government and industry settings as well as the more traditional PhD trajectory of scholarly and academic roles.
During the program, students will take independent courses that extend from a strong core of basic regulatory science coursework with a focus on three main areas: global product strategy, product lifestyle strategy, and project and human resources management.
The program is designed to meet the needs of individuals who are already working full-time outside of the university in positions in which they have substantial leadership or managerial responsibilities. A typical student in the program has somewhere between 10 and 15 years of experience in the regulated product industry with several years of experience managing or directing regulatory or quality departments.
Earn your Doctor of Regulatory Science online. Request more information .
Doctor of Regulatory Science Curriculum
The USC Doctorate of Regulatory Science degree requires satisfactory completion of 64 units beyond the baccalaureate degree, four of which are devoted to the writing of a thesis. Students with a master’s degree may receive partial credit for coursework taken for a previous graduate degree.
All students in the program are required to participate in experiential learning that would involve limited onsite activities and international travel.
Typically, courses offered by the Department of Regulatory and Quality Science can be taken either in-person or online (within the United States). Upon admission, a course plan will be developed to fit your needs.
Career Opportunities for Regulatory Science Graduates
The FDA offers employment in more than 30 distinct disciplines, and opportunities within the industry can be even more varied. The following are but a few of the broad range of job categories within regulatory and quality sciences:
Business development/corporate strategy
Government affairs and policy
Research and development
Clinical trials management
Risk management
Quality assurance and control
Good manufacturing processes
Quality system regulation
Domestic and international compliance
Supply chain management
Project management
Drug safety
Medical writing
Post-marketing surveillance
Comparative effectiveness
Reimbursement
Your career in regulatory science starts here. Request information today .
Designed for Working Professionals
All courses offered by the Department of Regulatory and Quality Sciences can be taken online or in-person. Created for working professionals who wish to further their education but cannot travel to traditional classrooms, online students participate in the same classes as students who attend onsite. Lectures can be viewed in real time or at another time.
Related Online Graduate Programs
Print Options
Bulletin 2024-2025, pharmaceutical sciences/regulatory affairs and quality assurance phd.
SCHOOL OF PHARMACY
Learn more about the Doctor of Philosophy in Pharmaceutical Sciences .
About the Program
The School of Pharmacy offers a graduate program leading to the PhD in Pharmaceutical Sciences with a concentration in Regulatory Affairs and Quality Assurance (RAQA). Emphasis is placed on combining scientific principles and methodology with regulatory and quality practices to streamline the discovery, manufacturing, safety profiling and post-approval processes. The program applies academic research methods to current industry regulatory issues, enabling candidates to pursue a dissertation that helps to define and resolve regulatory or quality problems with data research and scientific methodology. The goal of each dissertation is to present new and thoughtful answers to industry questions and problems that result in cost savings, safer and/or more effective products, better safety profiles, and other benefits for patients and manufacturers.
The RAQA concentration is designed for professionals who have a minimum of 15 years of relevant work experience, including supervisory responsibilities, in pharmaceutical and related sciences and/or regulation in such areas as analytical methods, clinical and pharmacovigilance supervision, corporate drug development or manufacturing science, quality practices, validation implementation, and other pertinent industry practices that draw heavily on regulatory policy and quality assurance. Work experience must be applicable to the topic candidates plan to investigate for their dissertation.
Selection is highly competitive as a very limited number of candidates is accepted each year. Successful candidates are expected to have:
a master’s degree or the equivalent in a pharmaceutical, science, medical, engineering or related field;
a minimum of 15 years of work experience in the field related to their PhD dissertation;
current work experience that can be applied to the regulatory/quality topic to be investigated for their PhD dissertation;
the ability to work both independently and as part of a team, displaying recognizable initiative;
a willingness to pursue original, independent research, utilizing a multidisciplinary approach to problem solving;
strong communication skills, both verbal and written, including the ability to write academic research papers containing original thought and cogent arguments;
basic knowledge of data analysis, having completed at least one course in statistical methods; and
the ability to accept constructive criticism and welcome feedback provided by the Dissertation Advisor and Dissertation Advisory Committee.
Time Limit for Degree Completion: 7 years
Campus Location: Health Sciences Center, Fort Washington
Courses may also be offered at Main campus. Research must be carried out, however, at the Health Sciences Center campus under the supervision of an advisor who is a member of the Graduate Faculty.
Full-Time/Part-Time Status: The degree is completed on a part-time basis in 2 to 5 years. Successful candidates are expected to pursue the PhD program at least two terms every academic year (Fall, Spring or Summer) until the dissertation is completed. Typically, students pursue the PhD every Fall and Spring term, but a Summer term may be substituted. Note that a minimum of one credit each Fall and Spring term is required to maintain the candidate’s active student status.
Job Prospects: Job opportunities include positions as postdoctoral researchers, scientists in the pharmaceutical industry, and faculty members.
Non-Matriculated Student Policy: Non-matriculated students are ineligible for participation in the program.
Admission Requirements and Deadlines
Application Deadline:
Fall: March 1
All applications are evaluated together after the deadline. Selection is highly competitive. A very limited number of candidates is accepted each year.
APPLY to this graduate program , submitting the application to [email protected] .
Letters of Reference: Number Required: 3
From Whom: Letters of recommendation should be obtained from college/university faculty members familiar with the applicant's academic competence and/or professionals in a supervisory position.
Master's Degree in Discipline/Related Discipline: A master's degree or equivalent is required in a pharmaceutical, science, medical, engineering or related field. Course credits achieved in the master's degree may be applied toward the PhD program's credit requirements.
Bachelor's Degree in Discipline/Related Discipline: A baccalaureate degree is required.
Transcripts from all post-secondary institutions attended may be sent electronically to [email protected]. Alternately, unopened official transcripts bearing the school’s seal must be sent directly from the Registrar at each institution to the School of Pharmacy’s Office of Graduate Studies.
Applicants who earned a degree at a non-U.S. institution must submit an equivalency evaluation of their transcript(s) through a third-party provider, either World Education Services (WES) or Educational Credential Evaluators (ECE) .
Statement of Goals: In approximately 500 to 1,000 words, state your specific interest in Temple's program, research goals, future career goals, and academic and research achievements.
Standardized Test Scores: Applicants who earned their baccalaureate degree from an institution where the language of instruction was other than English, with the exception of those who subsequently earned a master’s degree at a U.S. institution, must report scores for a standardized test of English that meet these minimums:
TOEFL iBT: 85
IELTS Academic: 6.5
PTE Academic: 58
Resume: Current resume or CV required.
Other Requirement: It is recommended that applicants provide a commitment statement from their employer indicating that the employer supports the individual’s involvement in the RAQA PhD program.
Program Requirements
General Program Requirements: Number of Credits Required Beyond the Baccalaureate: 40
Required Courses:
Course List
Code
Title
Credit Hours
Graduate-level coursework completed while earning a pharmaceutical, science, medical, engineering or related degree
30
Coursework beyond the MS degree
Seminar in Pharm Science
1
Graduate-level course in Data Science, Data Analytics, or Healthcare Analytics
3
Additional coursework as required by the Dissertation Advisor and School of Pharmacy Graduate Committee
Research Courses
Pre-Dissertation Research (2 terms)
4
Dissertation Research (2 terms)
2
Total Credit Hours
40
The School of Pharmacy accepts up to 30 credits. The decision of the School on the number of credits accepted is final.
A minimum of one 3-credit graduate-level course is to be completed. This coursework is related to decision analysis, quantitative methods, research design, scientific decision-making, statistics and probability for data analysis, and the like.
The number of credits accepted toward the PhD and the number required for completion of the PhD are determined by the Dissertation Advisor and the Graduate Committee of the School of Pharmacy. It may be determined that additional coursework is required to prepare the student to write the dissertation. The course grid below lists approved course options.
Additional Approved Coursework Options 1
Course List
Code
Title
Credit Hours
Statistical Quality Control
3
or
Statistical Design of Experiments (DOE)
Pharmaceutical Biotechnology
3
Generic Drug Regulation (ANDAs)
3
Process Validation
3
or
Computerized System Validation
Production of Sterile Parenterals
3
or
Sterilization Processes
Regulation of Medical Devices: Compliance
3
or
Regulation of Medical Devices: Submissions
Design Controls for Medical Devices and Combination Products
3
or
Risk Management of Pharmaceutical and Medical Devices
Good Pharmacovigilance Operations
3
or
Clinical Drug Safety and Pharmacovigilance
Microbiological Concepts in Pharmaceutical Manufacturing
3
Active Pharmaceutical Ingredients (APIs)
3
or
Global Pharmaceutical Excipient Regulation
Biologics/Biosimilars: A Regulatory Overview
3
Global Labeling Regulation: Principles and Practices
3
Regulatory Intelligence
3
Vaccines: Regulatory Affairs and Quality Assurance Issues
3
Pharmaceutical Quality Management Systems
3
or
Regulatory Sciences: Managing the Guidelines to Quality
Global CMC Issues and Regulatory Dossier
3
or
Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics
Benefit Risk Management and Safety Signaling of Healthcare Products
3
or
Regulatory and Legal Basis of Pharmacovigilance
Clinical Data Management (CDM)
3
Special Topics in Regulatory Affairs and Quality Assurance
3
Analytical Chemistry in Pharmaceutical Laboratories
3
or
Pharmaceutical Analysis
Preformulation - Small Molecules
3
or
Solid Dosage Forms: Small Molecules
Other coursework in Regulatory Affairs and Quality Assurance may also be assigned by the Dissertation Advisor.
QARA 5478 High Purity Water Systems is a third choice.
PS 5501 Development of Sterile Products is another option.
QARA 5505 Global Regulation of Medical Devices is also approved.
QARA 5591 Global Regulatory Affairs can also be selected.
QARA 5650 may only be taken with departmental approval.
Other Requirement: Formal evaluation of each PhD student’s progress occurs at the end of the first year and each year thereafter to ensure that the quality of work will result in a fully approved dissertation project. Failure to conduct a reasonable amount of research or writing could result in suspension or dismissal from the program. The following is a typical dissertation schedule:
Assess dissertation proposal topic, including candidate’s knowledge span to determine strengths and deficiencies.
Determine additional coursework required, if any.
Review candidate’s past work and publications as they pertain to the PhD dissertation.
Select final dissertation topic and possible research protocol.
Outline dissertation proposal, research protocol and introductory chapter by Year 1's end.
Meet with research advisor as required and recommended.
Pursue research activities to depict quantitative, qualitative and policy analysis methods, including literature review and annotated bibliography.
Prepare dissertation introduction, discussion and conclusion.
Final Year:
Prepare dissertation material for one or more publications.
Defend dissertation as required by the School of Pharmacy.
Culminating Events: Dissertation Proposal: The dissertation proposal demonstrates the student's knowledge of and ability to conduct the proposed research. The proposal should consist of:
the context and background surrounding a particular research problem;
an exhaustive survey and review of literature related to the problem; and
a detailed methodological plan for investigating the problem.
Upon approval of the dissertation proposal, the doctoral student is promoted to PhD candidacy, and a timeline for completing the investigation and writing process is established.
Dissertation: The doctoral dissertation is an original, theoretical and/or empirical study that makes a significant contribution to the field. It should expand existing knowledge and demonstrate the student's knowledge of research methods and a mastery of their primary area of interest. The dissertation should be rigorously investigated; uphold the ethics and standards of the field; demonstrate an understanding of the relationship between the primary area of interest and the broader field; and be prepared for publication in a professional journal. It is expected that the dissertation will consist of an appropriate mix of quantitative and qualitative research methodology and be suitable for publication.
The Dissertation Examining Committee (DEC) is formed to oversee the student's doctoral research. It is charged with evaluating the student's dissertation and oral defense, including the student's ability to express verbally their research question, methodological approach, primary findings and implications. The DEC, which includes the members of the DAC, is comprised of at least three Graduate Faculty members. Two members, including the Chair, must be from the School of Pharmacy. The Chair is responsible for overseeing and guiding the student's progress, coordinating the responses of the Committee members, and informing the student of their academic progress. At least one additional Graduate Faculty member from outside the School of Pharmacy must be included on the DEC. This outside examiner should be identified no later than the beginning of the academic term in which the student will defend the dissertation. The DEC members vote to pass or fail the dissertation and the defense at the conclusion of the public presentation.
Committee compositions must be approved by the departmental graduate committee. If a student needs to change a member of a committee, the new member must be approved by the departmental graduate committee and by the Graduate School. The changes must be documented with the Administrative Assistant and the Graduate School using the "Request for Change in Dissertation Committee" form, found in TUportal under the Tools tab within "University Forms."
Students who are preparing to defend their dissertation should confirm a time and date with their DEC and register with the Office of Graduate Studies at least 15 days before the defense is to be scheduled. The Office of Graduate Studies arranges the time, date and room and forwards to the student the appropriate forms. After the Administrative Assistant has made the arrangements, the student must send the Graduate School a completed "Announcement of Dissertation Defense" form, found in TUportal under the Tools tab within "University Forms," at least 10 days before the defense date. The department posts announcements for the defense.
The PDF will include all information unique to this page.
Download PDF of entire Undergraduate Bulletin
All pages in Undergraduate Bulletin
Download PDF of entire Graduate and Professional Bulletin
All pages in Graduate and Professional Bulletin
Skip to main content
Skip to FDA Search
Skip to in this section menu
Skip to footer links
The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
U.S. Food and Drug Administration
Search
Menu
FDA Organization
Center for Drug Evaluation and Research (CDER)
Regulatory Pharmaceutical Fellowship Program
The U.S. Food and Drug Administration (FDA) partners with universities and colleges of pharmacy in the United States to offer FDA-affiliated fellowship programs to Doctor of Pharmacy graduates in several specialties. The purpose of the Regulatory Pharmaceutical Fellowship program is to train selected candidates in one of six tracks focused on drug information, medication safety, regulatory advertising & promotion, regulatory affairs and policy, biopharmaceutical manufacturing, or regulatory science. The program provides participants with the unique opportunity to learn from mentors in their chosen specialty track across three diverse settings in government, academia, and industry. Graduates of the fellowship program are qualified to pursue careers in any of the three practice settings.
Recruitment is closed for 2024-2026 positions.
Program specific information, important dates, and links to more information about available 2025-2027 opportunities will be made available in October 2024.
Biopharmaceutical Manufacturing
Two-Year Biopharmaceutical Manufacturing Fellowship provided by Albany College of Pharmacy and Health Sciences
Four months with the Stack Family Center for Biopharmaceutical Education and Training (CBET) at Albany College of Pharmacy and Health Sciences in Albany, NY
Twelve months at Curia Global in global contract research, development and manufacturing at one or more locations
Eight months at FDA in the Office of Pharmaceutical Manufacturing Assessment in the Office of Pharmaceutical Quality in Silver Spring, MD
Two-Year Regulatory Advertising and Promotion Fellowship provided by Purdue University
Six months at Purdue University in Indianapolis, IN
Nine months at Johnson & Johnson in Titusville, NJ
Nine months at FDA in the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research in Silver Spring, MD (currently a remote work environment)
Two-Year Drug Information Fellowship provided by Belmont University
Seven months will be spent at Belmont University with practice site responsibilities in the HealthTrust Drug Information Service in Nashville, TN
Six months will be spent at Belmont University in the Christy Houston Foundation Drug Information Center in Nashville, TN
Five months will be spent at HealthTrust GPO Operations in Nashville, TN
Six months will be spent at FDA in the Division of Drug Information in the Center for Drug Evaluation and Research in Silver Spring, MD
Visit Belmont University's Drug Information Fellowship Website for eligibility criteria and key application dates. Questions? Contact [email protected] .
Two-Year Drug Information Fellowship provided by Purdue University
Six months will be spent at Purdue University in Indianapolis, IN
Twelve months will be spent at Eli Lilly & Company in Global Medical Information in Indianapolis, IN or at Janssen Scientific Affairs, LLC in Medical Information in Horsham, PA
Visit Purdue University's Drug Information Fellowship Website for eligibility criteria and key application dates. Questions? Contact [email protected]
Medication Safety
Two-Year Pharmacovigilance Fellowship provided by Albany College of Pharmacy and Health Sciences
Six months will be spent at Albany College of Pharmacy and Health Sciences in Albany, NY
Nine months will be spent remotely at BeiGene in Global Patient Safety
Nine months will be spent at FDA with Regulatory Science Staff in the Office of Surveillance and Epidemiology in Silver Spring, MD
Visit Albany College of Pharmacy and Health Sciences Fellowship Opportunities for eligibility criteria and key application dates. Questions? Contact [email protected]
Two-Year Medication Error Pharmacovigilance and Risk Management Fellowship provided by Butler University
Four months will be spent at Butler University in Indianapolis, IN
Twelve months will be spent at Regeneron Pharmaceuticals in Regulatory Affairs and Global Patient Safety in Tarrytown, NY
Eight months will be spent at FDA in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MD
Visit Butler University's Pharmacy Fellowship Programs Website for eligibility criteria and key application dates. Questions? Contact [email protected]
Two-Year Global Patient Safety and Pharmacovigilance Fellowship provided by Butler University
Four months will be spent at Butler University in Indianapolis, IN
Twelve months will be spent at Eli Lilly in Global Patient Safety in Indianapolis, IN
Eight months will be spent at FDA in the Division of Medication Error Prevention and Analysis in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MD
Two-Year Medication Safety Fellowship provided by Purdue University
Four months will be spent at Purdue University in Indianapolis, IN
Twelve months will be spent at AbbVie in Pharmacovigilance and Patient Safety in North Chicago, IL
Eight months will be spent at FDA in the Division of Risk Management in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MD
Visit Purdue University's Medication Safety Fellowship for eligibility criteria and key application dates. Questions? Contact [email protected]
Two-Year Risk Management Fellowship provided by Rutgers University
A longitudinal academic experience provided by Rutgers University in Piscataway, NJ with travel expected to the campus at least once monthly throughout the program
Twelve months at Pfizer in the Risk Management Center of Excellence in Collegeville, PA
Twelve months at FDA the Division of Risk Mitigation Assessment and Medication Error Surveillance, in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MD
Two-Year Regulatory Policy and Program Management Fellowship provided by Howard University
A longitudinal academic experience provided by Howard University in Washington, DC with travel expected to campus for predetermined instruction and development focused on the drug development process and its requisite policy
Eighteen months at Genentech in a rotational immersion in regulatory policy and program management in Washington, DC (travel expected as needed to the San Francisco Headquarters)
Six months at FDA in the Office of Medical Policy in Silver Spring, MD
Two-Year Regulatory Affairs and Policy Fellowship provided by Howard University
Six-month longitudinal academic experience at Howard University in Washington, DC with an emphasis on mastering research design and methodology, and understanding legislation and regulation. Fellows will have an opportunity to earn certificates in Teaching, Regulatory Writing, and Regulatory Affairs (RAC).
Twelve months at GlaxoSmithKline in a rotational immersion in regulatory advertising and promotion, strategy, and policy and intelligence.
Six months at FDA in the Office of Medical Policy in Silver Spring, MD focused in either patient labeling or regulatory policy
Regulatory Science
Two-Year Regulatory Science Fellowship provided by Rutgers University
Eight months will be spent in a clinical rotation experience, provided by Rutgers University Ernest Mario School of Pharmacy in Piscataway, NJ at an associated clinical practice site
Eight months will be spent at Sanofi in regulatory strategy exposure in the Regulatory Affairs North American organization in Bridgewater, NJ (travel expected as needed to the site)
Eight months will be spent at FDA in the Division of Pediatrics and Maternal Health in the Office of New Drugs in Silver Spring, MD
For questions about FDA-Affiliated Pharmacy Fellowship Programs that cannot be addressed directly to a specific program above, contact FDA’s Division of Drug Information at [email protected] .
Regulatory Science Fellowship Opportunity LEARN MORE
Improving the process of therapeutic development.
Harvard, MIT, and the FDA have partnered to create a center focused on regulatory science, bringing together a range of scientific disciplines that are applied to assess the quality, safety and efficacy of medicinal products and inform regulatory decision-making throughout the lifecycle of a medicine. Working across academia, industry, and government institutions, the Center promotes regulatory science through research and education programs, uniting stakeholders under a common mission: promoting optimal patient health outcomes through biomedical innovation and the availability of safe and effective diagnostics and treatments.
Featured Publications
The Regulatory Science Fellowship Program
Our fellowship program is affiliated with the FDA and focuses on training the next generation of regulatory science researchers. Learn more about the research our fellows are conducting or explore opportunities and how to get involved in our program.
News, Events, & Updates
Regulatory Science Forum with Tim Miller, PhD
“Opportunities for Large Language Models in Regulatory Science” September 17th: 12 – 1 PM EST
Register here
Innovators in Therapeutics Speaker Series
Dr. Mathai Mammen, M.D., Ph.D., CEO at FogPharma
October 8th: 12 – 1 PM EST
Twitter @Harvardmit_CRS
Harvard-MIT Center for Regulatory Science Follow
Center within @HiTSatHarvard @HarvardMed • Drug development, translational science & @US_FDA #FDAInformed
Next #RegSci Forum, on September 17th, will feature guest speaker Tim Miller @TMills on “Opportunities for Large Language Models in Regulatory Science”. Register here: https://rb.gy/psky6m
Thank you to guest speaker Scott Steele @FDACBER for his in-depth presentation on emerging technologies in the regulatory science space, and being a part of a great final #RegSci Forum for this academic year. Thank you to all who attended and participated this afternoon!
The next #RegSci Forum, on June 4th, will feature guest speaker Scott Steele @FDACBER on "Regulatory Science and Emerging Technologies". Register Here: https://rb.gy/8qoksz
Thank you to guest speaker @AndreaCoravos for presenting her unique perspective at today's #RegSci Forum, and sharing your story with our community! We greatly appreciate all who attended and participated in a great discussion!
The next #RegSci Forum, on May 7th, will feature guest speaker @AndreaCoravos on "From RegSci Classroom to Corporate Acquisition: The Story of HumanFirst". Register Here: https://rb.gy/2xs5yt
Sign up for our newsletter
The PhD scientist’s pathway into regulatory affairs
to post a comment. --> --> --> --> --> --> --> --> --> --> --> --> -->
University of Southern California
Sep 12, 2024
USC Catalogue 2021-2022
USC Catalogue 2021-2022[ARCHIVED CATALOGUE]
USC PharmD student John Wu administers a COVID-19 vaccine at the Dodger Stadium vaccination site, as California Governor Gavin Newsom and Los Angeles Mayor Eric Garcetti look on. Photo by Irfan Khan/Getty Images.
Non-Degree Programs
Courses of Instruction
Founded in 1905, the USC School of Pharmacy is the oldest and foremost pharmacy school in Southern California. The school is a national leader known for its progressive curriculum and research excellence. Approximately 50 percent of the practicing pharmacists in Southern California are graduates of USC. The school has an average student body of 755 full-time students in the PharmD program and 417 students pursuing MS, PhD, DRSc and undergraduate degrees in pharmacology and toxicology, pharmaceutical sciences, health economics, regulatory science, healthcare decision analysis and biopharmaceutical marketing. There are 77 full-time faculty and more than 300 part-time and volunteer faculty at the school.
The school occupies state-of-the-art facilities on the USC Health Sciences Campus in metropolitan Los Angeles, adjacent to the Los Angeles County+USC Medical Center (one of the largest teaching hospitals in the country), the USC Norris Cancer Hospital and the Keck Hospital of USC. USC School of Pharmacy students receive clinical training at these facilities and many other affiliated hospitals, healthcare clinics, skilled nursing facilities, home healthcare agencies and pharmacies in the Southern California region.
Recognized as one of the most innovative schools of pharmacy, the USC School of Pharmacy serves as a model for other progressive schools. In 1950, USC was the first to establish a Doctor of Pharmacy program. Additional national “firsts” that distinguish the school include: first clinical pharmacy program (1968); first PharmD/MBA dual degree program (1988); first MS and PhD programs in pharmaceutical economics and policy (1994) and first professional doctorate in regulatory science (2008).
Consistently the top private pharmacy school nationwide, the school is a member of the American Association of Colleges of Pharmacy, and the PharmD program is accredited by the Accreditation Council for Pharmacy Education, 135 S. LaSalle Street, Suite 4100, Chicago, IL 60603-4810, phone: (312) 664-3575; fax: (312) 664-4652 or (312) 664-7008.
USC School of Pharmacy 1985 Zonal Avenue Los Angeles, CA 90089-9121 (323) 442-1369 (phone) (323) 442-1681 (fax)
pharmacyschool.usc.edu Office of Admission and Student Affairs (PharmD) (323) 442-1466 Email: [email protected] Email: [email protected] pharmacyschool.usc.edu/apply/admission
Healthcare Decision Analysis 635 Downey Way Verna & Peter Dauterive Hall, VPD 312 Los Angeles, CA 90089-3333 (213) 821-6478 Email: [email protected] hcda.usc.edu
Biopharmaceutical Marketing 635 Downey Way Verna & Peter Dauterive Hall, VPD 312 Los Angeles, CA 90089-3333 (213) 821-6478 Email: [email protected] bpmk.usc.edu
Regulatory and Quality Sciences 1540 Alcazar St., CHP 140 Los Angeles, CA 90089 (323) 442-3102 Email: [email protected] regulatory.usc.edu
Administration
Vassilios Papadopoulos, DPharm, PhD, DSc (hon), Dean
Steven W. Chen, PharmD, Associate Dean for Clinical Affairs
Daryl L. Davies, PhD, Associate Dean of Undergraduate Education
Kari L. Franson, PharmD, PhD, Associate Dean for Academic and Student Affairs
Irving Steinberg, PharmD, Associate Dean for Faculty Affairs
Annie Wong-Beringer, PharmD, Associate Dean for Research Affairs
Curtis T. Okamoto, PhD, Associate Dean for Graduate Education and Postdoctoral Studies
Paul Beringer, PharmD, Chair, Titus Family Department of Clinical Pharmacy
Geoffrey Joyce, PhD, Chair, Department of Pharmaceutical and Health Economics
Eunjoo Pacifici, PhD, Chair, Department of Regulatory and Quality Sciences
Clay C.C. Wang, PhD, Chair, Department of Pharmacology and Pharmaceutical Sciences
John Stauffer Dean’s Chair in Pharmaceutical Sciences: Vassilios Papadopoulos, DPharm, PhD
William A. and Josephine A. Heeres, Endowed Chair in Community Pharmacy : Steven Chen, PharmD
University Professor and Boyd P. and Elsie D. Welin Professor in Pharmaceutical Sciences: Jean Chen Shih, PhD
Distinguished Professor of Pharmacy, Public Policy, and Economics and Leonard D. Schaeffer Director’s Chair : Dana Goldman, PhD
John A. Biles Professor in Pharmaceutical Sciences: Julio A. Camarero, PhD
Gavin Herbert Professorship in Pharmaceutical Sciences: Andrew MacKay, PhD
Charles Krown/Pharmacy Alumni Professor in Pharmaceutical Sciences: Enrique Cadenas, MD, PhD
Emeritus Professor and Dean: Timothy M. Chan, PhD
Emeritus Professors : Eric J. Lien, PhD; Bradley R. Williams, PharmD; Wei-Chiang Shen, PhD
Department of Pharmacology and Pharmaceutical Sciences
Professors of Pharmacology and Pharmaceutical Sciences: Enrique Cadenas, MD, PhD; Julio A. Camarero, PhD; Sarah F. Hamm-Alvarez, PhD; Vassilios Papadopoulos, DPharm, PhD; Jean C. Shih, PhD; Bangyan Stiles, PhD; Clay C.C. Wang, PhD
Associate Professors of Pharmacology and Pharmaceutical Sciences: Martine Culty, PhD; Roger F. Duncan, PhD; Ian S. Haworth, PhD; J. Andrew MacKay, PhD; Curtis T. Okamoto, PhD; Jennica Zaro, PhD
Assistant Professors of Pharmacology and Pharmaceutical Sciences: Zhipeng Lu, PhD; Paul Seidler, PhD; Jianming Xie, PhD; Yong (Tiger) Zhang, PhD
Professors of Clinical Pharmacy: Melvin F. Baron, PharmD, MPA; Paul M. Beringer, PharmD; Steven Chen, PharmD; Daryl Davies, PhD; Julie A. Dopheide, PharmD; Kari L. Franson, PharmD, PhD; Stanley G. Louie, PharmD; Tien M.H. Ng, PharmD; Fred G. Weissman, PharmD, JD; Annie Wong-Beringer, PharmD
Associate Professors of Clinical Pharmacy: Melissa Durham, PharmD; Kevin L. Forrester, PharmD; Lisa W. Goldstone, PharmD; William C. Gong, PharmD; Cynthia L.L. Lieu, PharmD; Emi Minejima, PharmD; Edith Mirzaian, PharmD; Dima M. Qato, PharmD, PhD, MPH; Irving Steinberg, PharmD; Fred G. Weissman, PharmD, JD
Assistant Professors of Clinical Pharmacy: Houda Alachkar, PharmD, PhD; Carla Blieden, PharmD; Amanda Burkhardt, PhD; Michelle Chu, PharmD; David Dadiomov, PharmD; Richard Dang, PharmD; Tatyana Gurvich, PharmD; Emily Han, PharmD; Connie Kang, PharmD; Kum Ja Lee, PharmD; Serghei Mangul, PhD; Scott Mosley, PharmD; Rory O’Callaghan-Kim, PharmD; Tam Phan, PharmD; Raffi Svadjian, PharmD, MBA; Patrick Tabon, PharmD; Ying Wang, PharmD; Paul J. Wong, PharmD; Maryann Wu, EdD
Research Professor: Jing Liang, MD, PhD
Research Assistant Professor of Clinical Pharmacy: Liana Asatryan, PhD
Department of Pharmaceutical and Health Economics
Professors of Pharmaceutical and Health Economics : Dana Goldman, PhD; Joel W. Hay, PhD; Darius N. Lakdawalla, PhD
Associate Professors of Pharmaceutical and Health Economics : Geoffrey Joyce, PhD; Grant D. Lawless, MD, RPh; Jeffrey S. McCombs, PhD; John Romley, PhD; Seth Seabury, PhD; Daniel Tomaszewski, PharmD, PhD; Ken S. Wong, PharmD, MPH
Assistant Professor s of Pharmaceutical and Health Economics : William Padula, PhD; Erin Trish, PhD
Research Assistant Professors of Pharmaceutical and Health Economics : Bo Zhou, PhD; Steven Fox, MD
Department of Regulatory and Quality Sciences
Professor, Department of Regulatory and Quality Sciences: Frances J. Richmond, PhD
Associate Professor, Department of Regulatory and Quality Sciences: Eunjoo Pacifici, PharmD, PhD
Assistant Professors, Department of Regulatory and Quality Sciences: Susan Bain, DRSc; Terry David Church, DRSc; C. Benson Kuo, PhD; Nancy Pire-Smerkanich, DRSc
The School of Pharmacy offers curricula leading to the Doctor of Pharmacy (PharmD) and Doctor of Regulatory Science (DRSc) degrees and graduate degrees through the Graduate School including: Doctor of Philosophy (PhD) in Health Economics; and the PhD Programs in Pharmaceutical and Translational Sciences which is a one-year umbrella program after which students select one of the following three tracks to complete their PhD degree in Pharmaceutical Sciences, Molecular Pharmacology and Toxicology, or Clinical and Experimental Therapeutics. The School also offers Master of Science (MS) in Pharmaceutical Economics and Policy; Master of Science (MS) in Pharmaceutical Sciences; Master of Science (MS) in Molecular Pharmacology and Toxicology; Master of Science (MS) in Clinical and Experimental Therapeutics; Master of Science (MS) in Healthcare Decision Analysis; Master of Science (MS) in Biopharmaceutical Marketing; Master of Science (MS) in Regulatory Science; Master of Science (MS) in Regulatory Management; Master of Science (MS) in Management of Drug Development; and Master of Science (MS) in Medical Product Quality. Eight dual degree programs are also offered, including: PharmD/PhD, PharmD/JD, PharmD/MBA, PharmD/MPH, PharmD/MS in Regulatory Science, PharmD/MS in Gerontology, PharmD/MS in Global Medicine, PharmD/MS in Healthcare Decision Analysis, and a joint degree in Pharmaceutical Economics and Policy (PhD). Graduate certificates include clinical research design and management, food safety, healthcare decision analysis, medical product quality, preclinical drug development, patient and product safety, and regulatory and clinical affairs.
The School of Pharmacy also offers a Bachelor of Arts (BA) and a Bachelor of Science (BS) in Pharmacology and Drug Development; a Bachelor of Arts (BA) and a Bachelor of Science (BS) in Biopharmaceutical Sciences; and minors in Biopharmaceutical Business, Science and Management of Biomedical Therapeutics, and Foundation in Regulatory Sciences.
Doctor of Pharmacy (PharmD) Program
Admission requirements for the doctor of pharmacy (pharmd) program.
Applicants should possess a bachelor’s degree from an accredited college or university. A cumulative grade point average of 3.0 and a prerequisite grade point average of 3.0 or higher is strongly recommended. All students should complete the pre-requisite courses that are required by the USC School of Pharmacy before they start the program. An interview is mandatory and required of all students prior to admission. International students are required to complete the TOEFL and may request a virtual interview.
Acceptance criteria will be assessed on a case-by-case basis. The admission committee reviews each student holistically, taken all application materials and the interview process into consideration when making an admission decision. Along with being academically prepared, having the soft skills to communicate, problem solve, build relationships and show your ability to think critically are important characteristics to demonstrate.
Tuition and Fees (Estimated)
Tuition for the PharmD at USC School of Pharmacy degree programs is charged at a flat rate (which differs from standard USC tuition). See the Tuition and Fees section for fee information. These fees are subject to change.
Doctor of Pharmacy students must pay a $1,000 non-refundable acceptance deposit that is applicable toward tuition. For deposit information in other degree programs in the School of Pharmacy, please consult appropriate offices.
Honor Societies
Theta chapter of Rho Chi, the academic honor society in pharmacy, was established at USC in 1925. Eligibility for membership is based on high attainment in scholarship, character, personality and leadership. All candidates selected for membership must have completed three semesters of the pharmacy program (or post-qualifying exam for PhD students), and they must be approved by the dean of the School of Pharmacy.
Phi Lambda Sigma
The Phi Lambda Sigma chapter was established at USC in 1988. This national pharmacy leadership society is devoted to identifying, supporting and recognizing the contribution of pharmacy students to their colleges, their classmates, their campuses, their communities and to their chosen profession.
Undergraduate Honors Program
The undergraduate honors in pharmacology and drug development (post code 1681) or biopharmaceutical sciences is awarded through successful completion of the senior capstone project. The project is a demonstration of knowledge in the student’s chosen area of interest which results in a product/project, research data, research paper, or portfolio of work, and a presentation. This experience encourages students to use a variety of skills in the areas of writing, speaking, research, and documentation, which distinguishes them as scholars and future leaders in pharmacy. Students will register in RXRS/BPSI - 493, Senior Honors Seminar I and RXRS/BPSI - 494 Senior Honors Seminar II.
Student Housing and Service Facility, Health Sciences Campus
There are no university-managed accommodations on the Health Sciences Campus. Currie Hall is privately owned, has a state-of-the-art fitness center, 24-hour academic success center, pool, wi-fi and fully furnished apartments with enhanced-privacy floor plans. For more information about Currie Hall, call (213) 784-7558 or visit the Currie Hall website .
For bookstore information, call (323) 442-2674. Students may also live in student housing on the University Park Campus, located about eight miles from the Health Sciences Campus.
Student Health Services, Health Sciences Campus
Services of the Student Health Center, covered by the mandatory student health fee, include the ambulatory care health services provided by the Student Health Center nursing staff. The Student Health Center is located in the USC Health Care Consultation Center, 1500 San Pablo Street, Suite 104, adjacent to the USC University Hospital, one block northeast of the School of Pharmacy. The telephone number is (323) 442-5980. In addition to the student health fee, all students must have major medical insurance coverage from the USC Student Health Plan. A student may request a waiver of the USC Student Health Plan if covered by a personal medical plan that meets criteria established by the Health Insurance Office.
Graduate Degrees
The School of Pharmacy, through the Graduate School, offers curricula leading to the MS and PhD degrees in clinical and experimental therapeutics, molecular pharmacology and toxicology, pharmaceutical sciences and health economics, as well as a doctorate in Regulatory Sciences (DRSc). The Pharmaceutical and Translational Sciences (PHTS) PhD Program is a one-year umbrella program after which students select a particular track to complete their PhD in pharmaceutical sciences, molecular pharmacology and toxicology, or clinical and experimental therapeutics. The school also offers interdisciplinary MS degrees in regulatory science, in regulatory management, in the management of drug development, in medical product quality, in healthcare decision analysis and in biopharmaceutical marketing. The MS degree in pharmaceutical economics and policy is offered jointly with the USC Price School of Public Policy and the Department of Economics. In addition, the school offers dual degrees with the schools of law, business, gerontology and medicine as well as other programs. Instructions given in the Admission section of this catalogue are to be followed. An online application is required. See the Graduate Admission application page. Additional information may be obtained by calling (323) 442-1474 or sending an email to [email protected] .
Admission Requirements for the Master of Science in Clinical and Experimental Therapeutics
Applicants should possess a bachelor’s degree or equivalent from an accredited college or university. Applicants with graduate or professional degrees are encouraged to apply. A minimum grade point average of 3.0 (A = 4.0) and qualifying scores on the GRE or equivalent examination are required. Special attention is given to the grades achieved in science courses relevant to the program (e.g., chemistry, biology, biochemistry, pharmacology and mathematics). Students who have research experience and/or work experience in the pharmaceutical arena are encouraged to apply.
Acceptance criteria for those individuals will be assessed on a case-by-case basis. English proficiency is essential. Students will be selected for admission, whenever possible, after interviews with one or more members of faculty.
Admission Requirements for the Master of Science in Molecular Pharmacology and Toxicology and Master of Science in Pharmaceutical Sciences
Applicants should possess a bachelor’s or master’s degree in pharmacy, chemistry, biology or other related disciplines from an accredited college or university. A minimum grade point average of 3.0 is required. Submission of scores on the GRE in the verbal and quantitative areas is strongly recommended. Special attention is given to the grades achieved in science courses relevant to the program (e.g., chemistry, biology, biochemistry, pharmacology and mathematics).
Applicants must have demonstrated proficiency in verbal and written English and in fundamental scientific areas such as organic and physical chemistry, biochemistry, biology, mathematics, statistics and computer science. Three letters from faculty knowledgeable about the student’s ability and capability are required. These letters should provide a thorough assessment of the student’s experience in laboratory research, ability to communicate in verbal and written English, motivation and creativity, and other qualities in the student’s academic performance.
Applications for admission are reviewed by the Pharmacology and Pharmaceutical Sciences Graduate Admissions Committee of the School of Pharmacy and are evaluated primarily on the basis of academic excellence.
Admission Requirements for Programs in Pharmaceutical and Translational Sciences: Doctor of Philosophy in Clinical and Experimental Therapeutics, Doctor of Philosophy in Molecular Pharmacology and Toxicology, and Doctor of Philosophy in Pharmaceutical Sciences
All prospective students will apply through the single umbrella program in Pharmaceutical and Translational Sciences and become enrolled in one of the three participating PhD programs after having successfully completed the first year’s course work and laboratory rotations. Application materials will be reviewed by a joint admission committee, with equal representation of faculty from each track, evaluating applications on the basis of academic excellence and scientific research commitment.
Applicants must have a baccalaureate degree in the natural sciences, or sufficient courses in mathematics and the life sciences. This is required to provide a strong background for studies in biomedical and biological research. Appropriate undergraduate degrees include biology, physiology, engineering, chemistry or computer science. A student currently enrolled in the PharmD program may pursue a PharmD/PhD by following the admission procedure in the Catalogue.
Applicants should have a strong record of academic achievement. A minimum grade point average of 3.0 is required and previous research experience is expected.
In addition to the application for admission, three letters of recommendation from faculty knowledgeable of the student’s ability and capability are required. These letters should provide a thorough assessment of the student’s experience in laboratory research, ability to communicate in verbal and written English, motivation, creativity and other qualities in the student’s academic performance. The student’s research and professional experience should be well described within the application and include a personal statement summarizing career objectives and research interests.
Admission Requirements for the Master of Science in Pharmaceutical Economics and Policy
Applicants for admission must have achieved a minimum 3.0 GPA in an undergraduate or professional school and adequate scores on the GRE. In addition, applicants will be required to have completed upper-division courses in statistical methods, calculus and microeconomics.
Admission Requirements for the Doctor of Philosophy in Health Economics
Candidates with a bachelor’s, master’s or PharmD degree are invited to apply. Applicants must have demonstrated proficiency in verbal and written English and aptitude in economics, mathematics, statistics and computer science. Deficiencies in economics and statistical background can be addressed through preliminary course work after admission to the program.
A minimum grade point average of at least 3.0 (A = 4.0) is required. Special attention is given to the grades achieved in economics, statistics and mathematics courses relevant to the program. A qualifying score on the GRE in verbal and quantitative areas is required. There is no set minimum score required for admission, and GRE scores are considered in conjunction with all other parts of the application.
Admission Requirements for the Master of Science in Healthcare Decision Analysis
Applicants should possess a bachelor’s degree or equivalent from an accredited college or university. Applicants with graduate or professional degrees are encouraged to apply. A minimum grade point average of 3.0 is required. The program encourages the participation of part-time students with work experience. Acceptance criteria for those individuals will be assessed on a case-by-case basis. English proficiency is essential. Additional requirements for international students are outlined by university regulations under Admission of International Students.
Admission Requirements for the Master of Science in Biopharmaceutical Marketing
Applicants should possess a bachelor’s degree or equivalent from an accredited college or university. Applicants with graduate or professional degrees are encouraged to apply. A minimum grade point average of 3.0 and qualifying scores on the GRE or GMAT examinations are required. The program encourages the participation of part-time students with work experience. Acceptance criteria for those individuals will be assessed on a case-by-case basis. English proficiency is essential. Additional requirements for international students are outlined by university regulations under Admission of International Students.
Admission Requirements for the Doctorate of Science in Regulatory Science
The program is designed for individuals with strong professional experience and demonstrated intellectual and leadership capabilities. Applicants are expected to have a GPA of 3.0 on university-level course work and ten or more years of professional experience. Admission requirements include university transcripts, a résumé or curriculum vitae, at least three letters of reference, and a one-page personal statement that outlines the background, a topic of interest for the dissertation and goals of the applicant. Students are encouraged even at this early stage to identify areas in which they are interested in conducting research. Additional requirements for international students are outlined by university regulations under Admission of International Students. (See Admission and Orientation .) Students are not required to provide GRE scores unless indicated by the program director. Applicants will be selected for admission, whenever possible, after interviews with one or more members of faculty, current student and/or alumnus of the program.
Students with an appropriate graduate or professional degree may use some previous graduate courses as transfer units toward the overall credit requirements of the Doctor of Regulatory Science program with the approval of the program director and under the policies of the university. Students who have graduated from the Master of Science program in Regulatory Science at USC are eligible to apply all of the previously taken course work toward the doctoral degree. Students with graduate degrees from outside of the Regulatory Science program are required to take a minimum of 32 units of course work and 4 units of dissertation research to complete the requirements for graduation. The course work requirements will be determined on an individual basis in consultation with the program director and student’s advisers.
Admission Requirements for the Master of Science in Regulatory Science
Applicants should possess a bachelor’s degree or equivalent from an accredited college or university. Applicants with graduate or professional degrees are encouraged to apply. A minimum grade point average of 3.0 and applicants are not required to provide GRE scores unless indicated by the program director. The program encourages the participation of part-time students with work experience.
Acceptance criteria for those individuals will be assessed on a case-by-case basis. English proficiency is essential.
Admission Requirements for the Master of Science in Management of Drug Development
Applicants should possess a bachelor’s degree or equivalent from an accredited college or university. Applicants with graduate or professional degrees are encouraged to apply. A minimum grade point average of 3.0 and applicants are not required to provide GRE scores unless indicated by the program director. The program encourages the participation of part-time students with work experience. Acceptance criteria for those individuals will be assessed on a case-by-case basis. English proficiency is essential.
Admission Requirements for the Master of Science in Medical Product Quality
Applicants should possess a bachelor’s degree or equivalent from an accredited college or university. Applicants with graduate or professional degrees are encouraged to apply. A minimum grade point average of 3.0 and applicants are not required to provide GRE scores unless indicated by the program director. The program encourages the participation of part-time students who are already working in the industry as well as students who have recently completed or are about to complete an undergraduate program.
Acceptance criteria will be assessed on a case-by-case basis. English proficiency is essential. Applicants who do not meet all the specific requirements indicated above, but who show unique potential, may be considered for admission with conditions, which may be fulfilled during the first semester of enrollment.
Admission Requirements for the Master of Science in Regulatory Management
Applicants should possess a bachelor’s degree or equivalent from an accredited college or university. Applicants should also possess a conferred doctoral degree or equivalent from an accredited college or university. A minimum grade point average of 3.0 and applicants are not required to provide GRE scores unless indicated by the program director. Acceptance criteria for those individuals will be assessed on a case-by-case basis. English proficiency is essential. The program encourages the participation of part-time students who are already working in the industry as well as students who have recently completed or are about to complete a doctoral program.
Acceptance criteria will be assessed on a case-by-case basis. English proficiency is essential. Applicants who do not meet all the specific requirements indicated above, but who show unique potential, may be considered for admission with conditions, which may be fulfilled during the first two semesters of enrollment.
Admission of International Students to Graduate Degree Programs
All requirements described in this section are also applicable to the admission of international students. In addition, special application and admission procedures are required of international students. Refer to the section on Admission of International Students in this catalogue.
Degree Requirements
These degrees are under the jurisdiction of the School of Pharmacy and/or jointly with the Graduate School. Students should also refer to the Requirements for Graduation section and The Graduate School section of this catalogue for general regulations. All courses applied toward the degrees must be courses accepted by the Graduate School.
Master of Science in Biopharmaceutical Marketing
Master of Science in Clinical and Experimental Therapeutics
Master of Science in Healthcare Decision Analysis
Master of Science in Management of Drug Development
Master of Science in Medical Product Quality
Master of Science in Molecular Pharmacology and Toxicology
Master of Science in Pharmaceutical Economics and Policy
Master of Science in Pharmaceutical Sciences
Master of Science in Regulatory Management
Master of Science in Regulatory Science
Doctor of Philosophy in Clinical and Experimental Therapeutics
Doctor of Philosophy in Health Economics
Doctor of Philosophy in Molecular Pharmacology and Toxicology
Doctor of Philosophy in Pharmaceutical Sciences
Doctor of Philosophy in Pharmaceutical Economics and Policy
Doctor of Regulatory Science
PharmD/Juris Doctor
PharmD/Master of Business Administration Dual Degree Program
PharmD/Master of Science, Gerontology
PharmD/Master of Science, Global Medicine
PharmD/Master of Science, Healthcare Decision Analysis
PharmD/Master of Public Health
PharmD/Master of Science, Regulatory Science
PharmD/Doctor of Philosophy
Office of Continuing Professional Development 1985 Zonal Avenue Los Angeles, CA 90089-9121 (323) 442-2403 FAX: (323) 442-3600 Email: [email protected] pharmacyschool.usc.edu/programs/ce/
Continuing Education
The School of Pharmacy, Office of Continuing Professional Development, is a recognized provider of continuing pharmacy education accredited by the Accreditation Council for Pharmacy Education (ACPE) and recognized by the California State Board of Pharmacy and throughout the United States.
The school serves as a primary educational resource for pharmacists in California and as a supplementary resource for other health professionals and pharmacists, nationally and internationally.
Programs are designed to educate pharmacists about current issues in pharmaceutical care, practice management, therapeutics and other topics of professional interest. Continuing education programs are held at the School of Pharmacy and other locations.
For information concerning continuing education programs contact the Office of Continuing Professional Development.
Bachelor’s Degree
• Biopharmaceutical Sciences (BA)
• Biopharmaceutical Sciences (BS)
• Pharmacology and Drug Development (BA)
• Pharmacology and Drug Development (BS)
• Biopharmaceutical Business Minor
• Foundation in Regulatory Sciences Minor
• Science and Management of Biomedical Therapeutics Minor
Joint Degree
• Pharmaceutical Economics and Policy (PhD)
Master’s Degree
• Biopharmaceutical Marketing (MS)
• Clinical and Experimental Therapeutics (MS)
• Healthcare Decision Analysis (MS)
• Management of Drug Development (MS)
• Medical Product Quality (MS)
• Molecular Pharmacology and Toxicology (MS)
• Pharmaceutical Economics and Policy (MS)
• Pharmaceutical Sciences (MS)
• Regulatory Management (MS)
• Regulatory Science (MS)
Dual Degree
• Doctor of Pharmacy/Doctor of Philosophy (PharmD/PhD)
• Doctor of Pharmacy/Juris Doctor (PharmD/JD)
• Doctor of Pharmacy/Master of Business Administration (PharmD/MBA)
• Doctor of Pharmacy/Master of Public Health (PharmD/MPH)
• Doctor of Pharmacy/Master of Science, Gerontology (PharmD/MS)
• Doctor of Pharmacy/Master of Science, Global Medicine (PharmD/MS)
• Doctor of Pharmacy/Master of Science, Regulatory Science (PharmD/MS)
• Healthcare Decision Analysis (PharmD/MS)
Graduate Certificate
• Advanced Pharmacy Practice Graduate Certificate
• Clinical Research Design and Management Certificate
• Food Safety Certificate
• Healthcare Decision Analysis Certificate
• Medical Product Quality Graduate Certificate
• Patient and Product Safety Certificate
• Preclinical Drug Development Certificate
• Regulatory and Clinical Affairs Certificate
Doctoral Degree
• Clinical and Experimental Therapeutics (PhD)
• Health Economics (PhD)
• Molecular Pharmacology and Toxicology (PhD)
• Pharmaceutical Sciences (PhD)
• Pharmacy (PharmD)
• Regulatory Science (DRSc)
Biopharmaceutical Marketing
• BPMK 500 Biopharmaceutical Marketing Management
• BPMK 501 Healthcare Payers, Insurance and Coverage Policy
• BPMK 502 Biopharmaceutical Product Development and Marketing
• BPMK 503 Biopharmaceutical Advertising and Communication
• BPMK 504 Market Access and Reimbursement Strategy
• BPMK 505 Product Health Economics and Valuation
• BPMK 506 Biopharmaceutical Product Pricing and Competition
• BPMK 508 Biopharmaceutical Marketing Research and Analytics
• BPMK 509 Seminars in Biopharmaceutical Marketing
• BPSI 405 Organ Systems Physiology, Drug Delivery and Drug Action
• BPSI 406 Drug Safety Pharmacology and Toxicology
• BPSI 407 Pharmaceutical and Health Economics
• BPSI 408 Biologics and Vaccines
• BPSI 410 Biopharmaceutical Product Development and Brand Planning
• BPSI 411 Biopharmaceutical Marketing Analysis and Strategy
• BPSI 412 Targeted and Precision Medicines
• BPSI 413 Rigor, Resources and Reproducibility
• BPSI 414 Pharmacoethics
• BPSI 415 Science Talk
• BPSI 490x Directed Research
• BPSI 493 Senior Honors Seminar I
• BPSI 494 Senior Honors Seminar II
Clinical and Experimental Therapeutics
• CXPT 590 Directed Research
• CXPT 594a Master’s Thesis
• CXPT 594b Master’s Thesis
• CXPT 594z Master’s Thesis
• CXPT 596 Internship for Curricular Practical Training
• CXPT 599 Special Topics
• CXPT 609 Preclinical Experimental Drug Therapeutic Development
• CXPT 610 Experimental and Clinical Drug Metabolism and Transport
• CXPT 664 Clinical Problem Solving
• CXPT 790 Research
• CXPT 794a Doctoral Dissertation
• CXPT 794b Doctoral Dissertation
• CXPT 794c Doctoral Dissertation
• CXPT 794d Doctoral Dissertation
• CXPT 794z Doctoral Dissertation
Health Care Decision Analysis
• HCDA 501 Fundamentals of Healthcare Insurance Design
• HCDA 502 Comparative International Healthcare Systems
• HCDA 503 Competitive Healthcare Intelligence
• HCDA 506 Foundations of Insurance and Global Access
• HCDA 507 Foundations of Product Development and Commercialization
• HCDA 510 Business Implications of Healthcare Policy
• HCDA 515 Healthcare Decision Analysis and Modeling
• HCDA 520 Health Economic and Outcomes Methodology
• HCDA 525 Healthcare Literature Analysis and Applications
• HCDA 530 Total Product Development: Benchtop to Launch
• HCDA 540 Executive Leadership and Healthcare Marketing
• HCDA 550 Healthcare Innovation: Creativity to Value
• HCDA 553 Advanced Pricing Strategies
• HCDA 560 Managing Effective Partnerships and Mergers
• HCDA 570 Asia Pacific: Access, Delivery and Reimbursement
• HCDA 580 Seminars in Healthcare Decision Analysis
• HCDA 589 Healthcare Consulting Enterprise Team Project
• HCDA 590 Directed Research
• HCDA 596 Internship for Curricular Practical Training
• HCDA 599 Special Topics
Molecular Pharmacology and Toxicology
• MPTX 500 Molecular Pharmacology and Toxicology I
• MPTX 501 Molecular Pharmacology and Toxicology II
• MPTX 502 Pharmacology
• MPTX 510 Topics in Pharmacology: the Other Side of Drugs
• MPTX 511 Introduction to Medical Product Regulation
• MPTX 512 Regulation of Pharmaceutical and Biological Products
• MPTX 513 Regulation of Medical Devices and Diagnostics
• MPTX 514 Regulation of Food and Dietary Supplements
• MPTX 515 Quality Systems and Standards
• MPTX 516 Medical Products and the Law
• MPTX 517 Structure and Management of Clinical Trials
• MPTX 518 Writing Regulatory Drug Submissions
• MPTX 519 Global Regulation of Medical Products
• MPTX 520 Toxicology and the Media
• MPTX 522 Introduction to Clinical Trial Design and Statistics
• MPTX 524 Introduction to Food Science and Technology
• MPTX 526 Chemistry Manufacturing and Controls
• MPTX 531 Cell Biology
• MPTX 561 Molecular Biology
• MPTX 571 Biochemistry
• MPTX 572 Medical Physiology I
• MPTX 573 Medical Physiology II
• MPTX 590 Directed Research
• MPTX 594a Master’s Thesis
• MPTX 594b Master’s Thesis
• MPTX 594z Master’s Thesis
• MPTX 596 Internship for Curricular Practical Training
• MPTX 599 Special Topics
• MPTX 602 Science, Research and Ethics
• MPTX 630 Directed Field-Research Project
• MPTX 700 Seminar in Molecular Pharmacology and Toxicology
• MPTX 790 Research
• MPTX 794a Doctoral Dissertation
• MPTX 794b Doctoral Dissertation
• MPTX 794c Doctoral Dissertation
• MPTX 794d Doctoral Dissertation
• MPTX 794z Doctoral Dissertation
• PHRD 501 Pharmaceutics I
• PHRD 502 Pharmaceutics II
The Fall 2025 Application will open October 1
Ms in regulatory science.
Behind every exciting research and development initiative in the medical and pharmaceutical industry, you’ll find skilled professionals dedicated to compliance, consumer safety, and public health.
MS in Regulatory Science Program Overview
A life-changing medical device. A time-saving, on-the-go meal. A revolutionary remedy.
We live in a day of innovation – but a lot happens between idea and execution. Regulations exist at nearly every stage in R&D, from clinical trials to marketing. With advancing technology, developing consumer standards, and evolving legislation and policies, leaders with expertise in regulatory affairs have perhaps never been more important to a company or organization’s success.
Whether your goal is to help companies bring compliant products to market or to ensure consumer safety through work with a government agency, you will find plenty of opportunities in the field of regulatory science.
A Closer Look: What is Regulatory Science?
The FDA defines regulatory science as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.” 1 Just a few examples on this list would include:
Medical devices
Pharmaceuticals
Veterinary products
Diagnostics
Food/beverage products
Nutritionals/vitamins
Other regulatory agencies include the USDA (meats, poultry, and produce), the Environmental Protection Agency (water, pesticides), the Federal Trade Commission (advertising practices), and the Consumer Product Safety Commission.
When you consider the vast number of products regulated by the government, it’s clear why regulatory science professionals are in higher demand around the globe.
Study on Your Terms
This online program is designed to offer the flexibility working professionals need while maintaining work, life, and school balance.
In-Depth Article
What is Regulatory Science?
Ethics, public health, and medicine intersect with compliance, consumer safety, and public health in regulatory science. Learn about potential career paths and the value of this master’s degree.
Upcoming Events
Biotechnology Community Social Hour
Ms in regulatory science information session, master of biotechnology enterprise and entrepreneurship info session, ms in bioinformatics information session, why to pursue an ms in ms in regulatory science at hopkins.
Capitalize On Our D.C. Location
JHU’s location gives us access to top professionals—and a front-row seat to the latest developments in regulatory affairs. Whether you’re on campus or across the country, you’ll learn from faculty members at the forefront of their fields.
Choose Electives to Fit Career Goals
Focus on the business side with classes such as Funding New Ventures, Marketing in a Regulated Environment, or Promotion of Biomedical Products. Or dive into the sciences with courses like Regenerative Medicine, Nanobiotechnology, or DNA Sequencing.
Expand Your Professional Network
When you enroll at Johns Hopkins, you become part of an international community of regulatory affairs and R&D professionals who work in labs, agencies, and companies around the world.
Leverage Your Experience and Expertise
Your past experience will give you an edge in your new career. According to the Regulatory Affairs Professionals Society, 88% of regulatory affairs professionals began their careers in another field.
Biotechnology News
Take the Next Step
Gain the skills and knowledge you need to bring innovative products to market while protecting public health and safety.
Contact Us for More Information
Advanced academic programs admissions, connect with us.
1 “Advancing Regulatory Science: Moving Regulatory Science into the 21st Century” Accessed online on December 3, 2021.
Audience Menu
Please select one of the options below:
Resident tuition
Non-Resident tuition
Your tuition estimate
Graduate key:
9+ credits for full-time
6 credits for part-time or working students
Drag the slider to see the tuition breakdown by credit hour
Tuition breakdown**
Academic Year Total
*This is not a bill. This is only an estimate. Special class fees are dependent on specific class enrollment and are not included here.
For additional cost estimates, view our standard cost of attendance .
How can we assist?
Skip to main content
Report an accessibility problem
Colleges and Schools
Online Doctor of Professional Practice (DPP) in Regulatory and Clinical Research Management
Pursue a Doctor of Professional Practice (DPP) in regulatory and clinical research management to lead at the forefront of the discovery and advancement of medical products. This program will complement your leadership experience in regulatory or clinical research management and enable you to strategically bring medical products to market. Upon graduation, you can seek advanced roles within commercial industry, community organizations, government agencies, health care institutions, academia and more.
Quick facts
Next start date: 08/21/2025
Total classes: 17
Weeks per class: 7.5
Total credit hours: 60
Degree questions, answered
Have questions about the Regulatory and Clinical Research Management (DPP) ? Fill out this form and we’ll get in touch!
* Indicates a required field
By submitting my information, I consent to ASU contacting me about educational services using automated calls, prerecorded voice messages, SMS/text messages or email at the information provided above. Message and data rates may apply. Consent is not required to receive services, and I may call ASU directly at 866-277-6589 . I consent to ASU’s mobile terms and conditions , and Privacy Statements , including the European Supplement.
Prepare for leadership roles in the medical and health care industries
What you’ll learn in this first-of-its-kind program.
Clinical research leadership.
Clinical trial design and management.
Data management and analysis.
Ethical and legal issues in clinical research.
Quality assurance and compliance.
Who’s a good candidate for this online doctoral program?
Will my diploma say ‘online’.
No, Arizona State University’s diplomas don’t specify whether you earn your degree online or in person. All diplomas and transcripts simply say “Arizona State University.”
Regulatory science and clinical research management courses
Your courses will focus on building the research, writing and leadership skills needed to navigate the complexities of medical product development. Key topics include quality control and assurance, responsible conduct and ethics, development and regulation of biologics and more. To culminate the program, you’ll complete an applied project on a research topic in the field. You’ll develop an applied project proposal, write the required chapters and give an oral defense.
The leadership roles this doctoral program prepares you for
This doctoral degree prepares you for advanced leadership opportunities in regulatory and clinical research practice settings. You can pursue a variety of growth opportunities in the pharmaceutical, biotechnology and medical device industries. You’ll also be equipped for prestigious positions within government agencies, such as the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). Additional career examples include, but aren’t limited to:
Learn alongside experts in clinical research management
The Edson College of Nursing and Health Innovation is the home to world-renowned and award-winning faculty members. Our faculty’s accomplishments include, but aren’t limited to:
Fulbright Senior Scholar.
National faculty nursing awards.
Rosalynn Carter National Leadership Award in Caregiving.
Ruth B. Freeman Award from the American Public Health Association.
How to apply
Applicants to the Doctor of Professional Practice (DPP) in regulatory and clinical research management must fulfill the requirements of both the Graduate College and the Edson College of Nursing and Health Innovation.
Application requirements
Applicants must have a minimum of a 3.00 cumulative GPA in an applicable master's program.
All applicants must submit:
Graduate admission application and application fee.
Official transcripts.
Personal statement.*
Up-to-date curriculum vitae or resume.
Two professional letters of recommendation.
*Applicants must provide a personal essay (no more than two pages double-spaced) detailing why they’ve selected the Doctor of Professional Practice in regulatory and clinical research management, what led them to apply and what motivates them to earn a doctorate in this field.
Additional admission information
An applicant whose native language is not English (regardless of current residency) must provide proof of English proficiency.
On the application, applicants will have an opportunity to provide an example of a published paper or graduate-level scientific paper (optional).
Please note additional program fees may apply.
Preparing the health leaders of tomorrow
ASU’s Edson College of Nursing and Health Innovation provides a world-class education to students across various health disciplines. We distinguish ourselves by delivering excellent programs and challenging courses led by high-quality instructors.
undergraduate, graduate and certificate programs online.
faculty members.
$13.2 million
in research awards.
Tuition calculator
Use our calculator to estimate your full-time or part-time tuition fees for this program prior to any financial aid. Keep in mind that most of our students receive financial aid, which can reduce out-of-pocket costs. Learn more.
You might also be interested in
Healthcare Innovation (MHI)
Starts 10/16/2024
Clinical Research Management – Regulatory Science (MS)
Clinical Research Management (MS)
Regulatory Science (MS)
What are you looking for?
Suggested searches.
Majors & Minors
Related Articles
Celebrating 25 years of usc’s institute for creative technologies, generous gift from jerre and mary joy stead boosts neurosurgery at usc.
PhD Regulatory Science
School of study
School of Life and Medical Sciences
!-->
An honours degree (normally at least 2:1 or above) in an appropriate discipline.
IELTS entry requirement is normally 6.5, TOEFL 550 (213 CBT) or equivalent for overseas students.
The part-time pathway requires a MSc/Mphil/MRes and work experience to enable completion in three years.
About the course
A University of Hertfordshire research degree is an internationally recognised degree signifying high levels of achievement in research. It develops extensive subject expertise and independent research skills that are honed over an extended period, depending on the level of the award.
You will undertake a substantial, original research project for the duration of the degree, under the supervision and guidance of two or more academic members of staff. Your supervisory team provides guidance both in the selection of a research topic and in the conduct of the research. You are also supported by attendance at postgraduate seminars to develop subject specific knowledge and research skills relevant to your field of research. The degree is assessed solely on the final research output, in the form of a substantial written thesis which must be "defended" in a viva. During the degree, you will be given opportunities to present your work at major conferences and in refereed research publications.
How to apply
To apply for a PhD at the University of Hertfordshire, you should have a specific developed area of focus. It is recommended that you have an established track record / experience in your desired area to support your application. The quality of your research proposal, your suitability for pursuing higher research and our capacity to supervise the chosen topic are the principal criteria for admission. You will need to submit a written research proposal and personal statement to the Doctoral College but informal discussion before formal application is strongly encouraged.
Teaching methods
A PhD is a not a taught course. Students are expected to initiate their learning and development through seeking out opportunities provided by the University. Your supervisors will assist and support you throughout your time with us.
The PhD programme can be undertaken on a full or part time basis and we endeavour to provide fully supportive research and learning environment with flexible supervision to enhance your experience and help you to make the most of your research learning time with us.
Your supervision team will have both subject expertise and PhD supervision experience.
Course experts
Programme Leader Sam Salek Find out more about Programme Leader Sam Salek
What’s next for my career?
By undertaking a PhD at the University of Hertfordshire you will gain:
recognition through showcasing the output of your research at the national and international forums
recognition as an expert in your field of research by publishing your work in peer reviewed and impactful scientific journals
an internationally recognised research qualification
advanced subject expertise at postgraduate level
research skills through practice and extensive research experience.
Employers are looking for high calibre graduates with advanced skills who can demonstrate independence through research and have track record of publication in their field of research.
Start Date
End Date
Year
Location
Link
01/10/2024
31/07/2025
1
UH Hatfield Campus
01/02/2025
31/07/2025
1
UH Hatfield Campus
01/10/2024
31/07/2025
1
UH Hatfield Campus
01/02/2025
31/07/2025
1
UH Hatfield Campus
Start Date
End Date
Year
Location
Link
01/10/2025
31/07/2026
1
UH Hatfield Campus
01/02/2026
31/07/2026
1
UH Hatfield Campus
01/10/2025
31/07/2026
1
UH Hatfield Campus
01/02/2026
31/07/2026
1
UH Hatfield Campus
Start Date
End Date
Year
Location
Link
01/10/2026
31/07/2027
1
UH Hatfield Campus
01/02/2027
31/07/2027
1
UH Hatfield Campus
01/10/2026
31/07/2027
1
UH Hatfield Campus
01/02/2027
31/07/2027
1
UH Hatfield Campus
#UHClearing
MS and Graduate Certificate in Regulatory Science
The exclusively online Master of Science and Graduate Certificate in Regulatory Science programs each provide students with the knowledge and skills necessary to contribute to drug and biologics regulation and pharmaceutical product lifecycles.
The online Master of Science and Graduate Certificate in Regulatory Science programs are now accepting applications for classes beginning in Fall 2024. The deadline to apply is June 30, 2024.
Apply before june 30, 2024, and the application fee will be waived email [email protected] for the fee waiver code. dual degree applicants (i.e. pharmd students at the university of maryland school of pharmacy) are not eligible for application fee waiver..
Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of products regulated by the Food and Drug Administration (FDA). The Master of Science (MS) and Graduate Certificate in Regulatory Science programs focus on drugs and biologics, although aspects of diagnostics, devices, and nutritional products are also addressed. The Graduate Certificate in Regulatory Science provides a more limited course of study than the MS degree program.
Watch this two-minute video to learn more about the MS in Regulatory Science program, including thoughts from current students and recent graduates.
Both programs cover all major areas of drug product and biologics regulatory science, including:
Chemistry, Manufacturing, and Controls (CMC)
Clinical Research
Pharmacovigilance
Phase IV Research (e.g., Pharmacoepidemiology)
Drug and Biologics Discovery
The strength of the MS program is its science-driven approach to drug and biologic product development and regulation. The program covers regulatory affairs in a global manner, including the application of regulatory principles worldwide. The program is not limited to regulatory affairs, and features lectures and student activities that span the discovery of drugs/biologics to post-market activities, with a scientific emphasis on development pathways, including common challenges and science-based solutions.
The Graduate Certificate consists of the first two courses of the MS program, for a total of 12 credits. It can be completed in less than one year, and is designed for students who seek a more limited course of study or commitment than the MS degree, which requires less than two years and 30 credits to complete. Certificate students can apply for the MS program at a later date, if desired, and apply their completed courses towards the MS degree.
Graduates of the MS in Regulatory Science program will be fluent in the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products
They will possess the knowledge and skills needed to:
Devise and implement global strategies for drug, biologic, and device development and evaluation
Differentiate USA and other regional requirements for drug product and biologics development and registration
Apply principles of basic and applied pharmaceutical sciences in drug and biologics discovery and development
Formulate critical elements of CMC to drug development
Relate principles of clinical research design to practices in clinical trial management
Apply critical methods of risk assessment and drug utilization from pharmacoepidemiology and post-marketing surveillance, and evaluate economic and sociodemographic factors that influence drug use
The program has provided me with the opportunity to develop a greater understanding of regulatory science, which is essential to my work as an administrator for the protection of human subjects in research. The curriculum has provided a rich educational experience that challenges me to improve my research and decision-making skills. The program is truly designed to be as rigorous as a traditional in-person master’s degree program.
With the knowledge and skills obtained through the MS in Regulatory Science program, graduates will have access to a number of opportunities in drug and biologics research and development.
Regulatory science/affairs positions at pharmaceutical companies, as well as device and biotechnology companies
Regulatory science/affairs positions at government agencies, such as the Food and Drug Administration (FDA), National Institutes of Health (NIH), Department of Defense, Biomedical Advanced Research and Development Authority, and the Centers for Disease Control (CDC)
Admission into PhD programs
Download our program fact sheet or visit the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) website.
BECOME A MEMBER
Our mission and values
Our history
Partnerships and Affiliations
TOPRA Strategic Plan 2020–2025
What is Regulatory Affairs?
Member updates
Communities
Volunteering
Become a Fellow
Diversity & Inclusion
Board elections
Career progression
All courses & events
Conferences & networking
Qualifications
Apprenticeship
Professional registration
CPD and lifelong learning
Innovation Summit
TOPRA Summit
Regulatory Careers Live
Degree accreditation
News & insights
Regulatory Rapporteur
Members-only newsletters
TOPRA Engage+ App
TOPRA Connect newsletter
Medical device resources
Reg Intelligence Knowledge Hub
Sustainability
Wall Planner
Glossary of RA terms
Advertising opportunities
Exhibition opportunities
Hire our meeting rooms
Sponsorship opportunities
Services directory
About TOPRA
Professional development, membership & communities, topra services, phd in regulatory affairs.
TOPRA has a joint agreement for PhD students with the University of Hertfordshire (UH) looking to pursue a doctorate in Regulatory Affairs.
Duration of study for completing the PhD
This should be completed in no longer than four years – three years for the research plus one year allowed for writing the thesis. However, the candidates would be able to submit their thesis and complete at the end of a three-year period.
Part-time already holding a MSc degree
This will take seven years - five years of research with an additional two years for writing the thesis. However, the candidates may be able to submit their thesis early if their supervisor agrees and the candidate's day-to-day work is related to their project.
Entry requirements
Applicants must have:
a minimum of a 2:1 undergraduate degree, or a MSc in an appropriate subject
a minimum of two years' experience working in regulatory affairs
(for applicants whose first language is not English) an IELTS score of 7 overall with no less than 6.5 in any individual component
a valid study visa issued by UKVI if they are full time, from outside the UK and are to spend any time studying at UH premises.
The suitability of candidates to pursue a PhD degree by research will be sought from their referees.
Current fees can be found on the University of Hertfordshire's website
A bench fee of £1000 per annum for part-time and £2000 per annum for full-time candidates will also be payable. (This is standard practice for universities in the UK.)
These fees should be paid directly to the University of Hertfordshire.
An additional compulsory and non-refundable annual fee of £500 plus VAT will be payable to TOPRA which permits students to:
attend relevant TOPRA events (this does not cover travel and accommodation)
have membership of TOPRA for the duration of their study (including access to the Regulatory Rapporteur Journal)
gain assistance from TOPRA in finding a suitable industrial mentor in the area of their PhD project
obtain general advice and support, for those candidates experiencing difficulty during their study
TOPRA will also support the PhD student by (including but not limited to): handling and reviewing of applications, record keeping, assistance with topics and administration for attendance at any relevant TOPRA events.
Applications and registration
Students should in the first instance submit an application form and their CV to the TOPRA office.
Applications will be processed by UH through the standard application process for PhD applicants.
For the avoidance of doubt, UH’s decision on whether to admit an applicant onto a PhD program is final.
Once accepted onto the PhD program the student will have use of all UH facilities available to the student body, including library, computing and student support, and will be eligible to attend the UH graduation ceremony if they successfully complete the PhD.
Supervision
The student will have at least two supervisors: at least one academic supervisor from UH and at least one industrial supervisor recommended by TOPRA and approved by UH.
All supervisors must meet the requirements set out in UH’s regulations in terms of subject knowledge and supervisory experience.
All candidates must adhere to the UH regulations for PhD research degree and fulfil all the reporting, monitoring and supervisory requirements for the duration of their PhD programme.
During the course of the PhD, the student’s progress will be discussed between TOPRA and UH, subject to the consent of the student. The University will issue a report every six months on the progress of all relevant PhD students to TOPRA.
To apply, or for more information, email us
Share on Facebook
Share on Twitter
Share on LinkedIn
More options
StumbleUpon
Regulatory Science, MS
Program description
At a glance
Degree requirements
Admission requirements
Tuition information
Attend online
Application deadlines
Career opportunities
Contact information
Health, Quality, REGULATORY, Science
Join in the mission to ensure the safety and efficacy of life-changing products, from life-saving medicines to cutting-edge medical devices. This program will empower you to contribute to society, protect public health and drive innovation.
The MS program in regulatory science is designed for students interested in protecting public health through the discovery, development and marketing of medical products to the consumer. In particular, this program focuses on drugs and devices, preparing students for careers in the pharmaceutical, medical research and medical device industries.
While earning the Master of Science in regulatory science, students delve into all aspects of regulatory affairs, including:
clinical research
drug and medical device development
ethical and legal aspects
global regulatory practices
manufacturing
regulatory submissions
The field of regulatory science focuses on the application of regulations throughout the life cycle of medical products and compliance with regulations in the development, approval and marketing of medical products. This advanced degree incorporates a transdisciplinary approach to meet the unique needs of regulating bodies and the industry.
College/school: Edson College of Nursing and Health Innovation
Location: Downtown Phoenix or Online
STEM-OPT extension eligible: No
33 credit hours including the required applied project course (HCR 593)
Required Core (18 credit hours) HCR 553 Quality Assurance and Clinical Research (3) HCR 561 Responsible Conduct of Clinical Research (3) HCR 563 Fundamentals of Regulatory Affairs (3) HCR 576 Drug Discovery, Development and Regulations (3) HCR 577 Global Regulatory Affairs (3) HCR 578 Legal Aspects of Clinical Research (3)
Restricted Electives (12 credit hours) HCR 552 Medical Device Development and Regulation (3) HCR 555 Pharmaceutical Safety and Risk Management (3) HCR 557 Clinical Research Design and Methods (3) HCR 558 Technical Writing for the Regulatory Professional (3) HCR 564 Global Regulatory Affairs Leadership (3) HCR 568 Health Care Project Management (3) HCR 575 Management and Negotiation of Clinical Trial Budgets and Contracts (3) HCR 579 Translational Research in Drug Discovery and Development (3)
Additional Curriculum Information For electives coursework, students choose four courses for 12 credit hours from the restricted electives list. Other coursework may be substituted with approval from the academic unit.
Applicants must fulfill the requirements of both the Graduate College and the Edson College of Nursing and Health Innovation.
Applicants are eligible to apply to the program if they have earned a bachelor's or master's degree from a nationally recognized, regionally accredited academic institution.
Applicants must have a minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in the last 60 hours of their first bachelor's degree program or a minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in an applicable master's degree program.
All applicants must submit:
graduate admission application and application fee
official transcripts
resume or curriculum vitae
two online recommendations
personal statement
proof of English proficiency
Additional Application Information An applicant whose native language is not English must provide proof of English proficiency regardless of their current residency.
The online references should be from professional colleagues, supervisors, professors or other professional contacts and should attest to the applicant's academic and leadership experiences.
ASU offers this program in an online format with multiple enrollment sessions throughout the year. Applicants may view the program’s ASU Online page for program descriptions and to request more information.
Session
Modality
Deadline
Type
Session A/C
In Person
07/19
Final
Session A/C
In Person
05/01
Priority
Session
Modality
Deadline
Type
Session A/C
In Person
12/01
Final
The field of regulatory affairs continues to grow as pharmaceutical and medical development advances. Companies are eager to hire regulatory science professionals into jobs such as:
compliance officer
FDA inspector
quality assurance specialist
quality control specialist
regulatory affairs professional
regulatory coordinator
regulatory manager
regulatory scientist
Edson College of Nursing and Health Innovation | MERCC 250 [email protected] 602-496-0937
MS in Regulatory Science
MS Admissions
Course Schedules
Curriculum and Requirements
Frequently Asked Questions
On-Site / Distance Program
Scholarships
The biomedical industry has grown rapidly, and this has fueled a large — and largely unmet — demand for regulatory professionals, both nationally and internationally. The USC Master’s in Regulatory Science program arose to meet this growing need.
As one of the nation’s oldest and largest regulatory science programs, graduates are in great demand and are employed in industry, government, consulting and academia. Our alumni are leaders in a field designed to meet industry and governmental challenges in speeding up delivery of medical advances to people who need them, while ensuring that safety standards are met.
Courses are offered on weekends to accommodate working professionals. Students set their own pace, taking as many courses as they wish to take each semester. Career support is offered to all students and alumni, including recruitment events, career fairs and regular distribution of job postings from companies nationally and internationally.
What are some biggest advantages of the USC master’s in regulatory science program?
“The program provides a lot of opportunities — from career fairs to expert guest speakers from industry. Being able to meet all these people while a student is one of the best things about this program. Our classmates also bring unique perspectives from their own experience working for different companies.”
PharmD ’21, MS Regulatory Science ’21
Senior regulatory affairs cmc associate at gilead sciences.
Why was the USC master’s in regulatory science program the right fit for you?
“USC was my number one choice for a regulatory science program. It is the perfect program for anyone who wants to combine business, healthcare and management into one degree and many career opportunities.”
Aashrey Kaul
Ms regulatory science ’19, regulatory specialist at researchdx.
Why did you decide to pursue an MS in Regulatory Science?
“My passion for regulatory science stems from my aspiration to contribute to the delivery of new drug products that will target the current unmet medical need and enhance patients’ lives on a global scale.”
Yurim Rachel Seo
Pharmd ’21, ms, regulatory science ’21, medical affairs global medical communications extern – oncology, amgen.
What originally attracted you to your field?
“As a respiratory therapist at Keck Medicine of USC, I have always been interested in clinical trials and wanted to know more about how to help and be involved in the future of medicine where I could have a bigger impact than just a few patients at a time. I met Dr. Frances Richmond (and the rest of the regulatory science team at USC Mann) and decided the master’s in regulatory science would help me achieve these goals.”
Daniel Stemen
Ms regulatory science ’21, manager of respiratory care and interventional pulmonary services at keck medicine of usc.
What are you most looking forward to in your career?
“I’m excited to help patients on a global scale through my experiences in regulatory affairs, clinical development and operations, and clinical pharmacology.”
PharmD ’20, MS Regulatory Science ’20
Senior regulatory affairs associate at gilead sciences.
Continuing Education
Master of Medicines Regulatory Affairs
Drug Regulatory Science
This course is a part of.
Regulation of medicines should be based on reliable science. With Regulatory Science we study both intentional as well as unintentional effects of drug regulation, regulatory instruments and regulatory decision-making, on drug development and innovation and on public health.
Per Sindahl, PhD fellow at Copenhagen Centre of Regulatory Science, has an interesting take on that:
“As we demand that medicines are effective, this should also be the case for the system overseeing medicines. In other words, the regulation of medicines must contribute to the patients’ safety, and we should know to what extent it does.”
Course content
This course introduces the concept of regulatory science as the foundation of both regulatory and legislative decisions.
At this course, you will be presented with fundamental scientific investigations that challenge your perception and incentive to use new tools and standards to evaluate the efficacy, safety, quality and performance of medical products.
You will be taught how to evaluate the performance of drug regulations and regulatory instruments, the gaps of the tools and how to choose tools and methods that support regulatory decision-making.
Teaching includes lectures, case-studies, oral presentations and group discussions. Participants are trained to critically reflect on pharmaceutical legislation and guidelines, which are critical to ensure a quality-based storyline.
Course Director on Drug Regulatory Science
Christine Erikstrup Hallgreen
Course details for drug regulatory science, dates and examination.
Course dates
18-20 November 2024.
The course is available every second year.
Examination
Please find the exam dates in the exam plan. You can find further information about the course and the exam in the course curriculum .
See an overview of all courses on Master of Medicines Regulatory Affairs .
Learning outcomes
The scientific approach enables you to challenge current concepts of benefit/risk assessment. You will get skills to facilitate a sound and transparent regulatory decision-making and rethink your approval strategies based on clinical relevance and scientific legitimacy.
Admission criteria
Regulatory affairs specialists striving to innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialists employed in industry, regulatory agencies or consulting.
You must meet the following criteria to be admitted to this course:
Hold a relevant bachelor degree or equivalent
Have a minimum 2 years of relevant job experience
Be proficient in English
Find detailed information in the admission criteria on Master of Medicines Regulatory Affairs.
You will receive a response to your application at the earliest on 1 May and no later than 2 weeks after the application deadline.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Medicines Regulatory Affairs programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
PhD projects in Regulatory Science with involvement of the MEB
PhD Careers In Clinical, Medical, And Regulatory Affairs
Facts & figures of Regulatory Science
PhD projects in Regulatory Science with involvement of the MEB
Doctorate of Regulatory Science Info Session July 21, 2021
Regulatory Science & Tools
VIDEO
Master of Medicines and Regulatory Affairs Promotion
Master of Pharmaceutical Science
How Will Generative AI Take Your Regulatory and Medical Writing Program to the Next Level?
Developing the Approach Section for Tobacco Regulatory Science Proposals
Regulatory Agencies in India/Pharmaceutical Regulatory Science/PRS/B.Pharm
Licensing Professional Development: Regulation Theories of Monitoring and Innovation in Licensing
COMMENTS
Doctorate in Regulatory Science
Learn about the only doctoral program in regulatory science in the world, designed for advanced students who want to lead in the global medical products industry. The program combines research, leadership and inquiry skills with courses in strategic management, policy development and product lifecycle strategy.
Doctor of Regulatory Science
Learn how to manage and lead in the regulated product industry with the first online DRSc program in the world. The program combines online and in-person courses, experiential learning and a thesis to prepare you for senior positions in government, academia and industry.
Pharmaceutical Sciences/Regulatory Affairs and Quality Assurance PhD
About the Program. The School of Pharmacy offers a graduate program leading to the PhD in Pharmaceutical Sciences with a concentration in Regulatory Affairs and Quality Assurance (RAQA). Emphasis is placed on combining scientific principles and methodology with regulatory and quality practices to streamline the discovery, manufacturing, safety ...
Department of Regulatory and Quality Sciences
Mirroring the working environment of the industry, our programs emphasize collaborative problem-solving, communication, teamwork, cross-functional fluency and other soft skills essential for success in all aspects of regulatory and quality sciences—from shaping individual company strategies to ushering in systemic change to advance the entire profession.
Regulatory Science (DRSc)
Regulatory Science (DRSc) The Doctor of Regulatory Science program cultivates research, leadership and inquiry skills for advanced students in the emerging profession of global regulatory science. It is designed to produce graduates with expertise in strategic management, policy development and research assessment who can play leadership roles ...
Curriculum and Requirements
The USC Doctorate of Regulatory Science degree requires satisfactory completion of 64 units beyond the baccalaureate degree, 4 of which are devoted to the writing of a thesis. Students with a master's degree may receive partial credit for coursework taken for a previous graduate degree. Program Structure The program is organized as a series of […]
Regulatory Pharmaceutical Fellowship Program
Information about the two-year post-graduate Regulatory Pharmaceutical Fellowship program. This program is jointly sponsored by academia, industry, and government, and offers specialized ...
PhD
In 2018, Temple University School of Pharmacy established an RAQA PhD concentration within the Pharmaceutical Science doctoral program. This degree meets the needs of professionals working in regulated industry and various regulatory authorities, who have worked for decades in RA/QA and are highly accomplished experts seeking a doctoral degree ...
Admissions
Admissions. To apply to the DRSc program, you must: Have completed a bachelor's degree with a minimum grade point average (GPA) of 3.0 from an accredited college or university.*. Submit three letters of recommendation from professionals or professors familiar with your capabilities and achievements. Submit a copy of your most up-to-date ...
CRS
Harvard, MIT, and the FDA have partnered to create a center focused on regulatory science, bringing together a range of scientific disciplines that are applied to assess the quality, safety and efficacy of medicinal products and inform regulatory decision-making throughout the lifecycle of a medicine. Working across academia, industry, and ...
The PhD scientist's pathway into regulatory affairs
Making a transition from a life and health science research scientist to regulatory affairs professional can be challenging. It is difficult to gain the requisite experience in an academic or industry research setting. However, the combination of an advanced science degree, transferable skills, and professional experiences can make this transition attainable.
USC School of Pharmacy
Admission Requirements for the Doctorate of Science in Regulatory Science. The program is designed for individuals with strong professional experience and demonstrated intellectual and leadership capabilities. Applicants are expected to have a GPA of 3.0 on university-level course work and ten or more years of professional experience. Admission ...
MS in Regulatory Science
MS in Regulatory Science Program Overview. A life-changing medical device. A time-saving, on-the-go meal. A revolutionary remedy. We live in a day of innovation - but a lot happens between idea and execution. Regulations exist at nearly every stage in R&D, from clinical trials to marketing. With advancing technology, developing consumer ...
Doctor of Regulatory + Clinical Research Management
In the first doctoral program to combine regulatory science with clinical research management, you'll learn about a leader's role in developing new medical products efficiently. In your courses, you'll hone your interpersonal, analytical, ethical and cultural competencies. You'll also build a knowledge base related to regulatory and ...
Frequently Asked Questions
The Master of Science in Regulatory Science is an intensive, interdisciplinary program within the school designed to produce graduates whose backgrounds in biological, pharmaceutical, and biomedical sciences are enhanced by the knowledge and skills needed to manage regulated biomedical products. You can also read an FDA article "Why You ...
Doctor of Pharmacy/Master of Science, Regulatory Science (PharmD/MS)
Doctor of Pharmacy/Master of Science, Regulatory Science (PharmD/MS) - USC. Updated: Thursday, August 15, at 6 a.m. PT. USC is a constellation of schools, centers and institutes where some of the brightest minds are leading the way to the future of education. USC, L.A. and California's southland are inextricably linked.
PhD Regulatory Science
PhD Regulatory Science. Key information. School of study. School of Life and Medical Sciences. Entry requirements. An honours degree (normally at least 2:1 or above) in an appropriate discipline. IELTS entry requirement is normally 6.5, TOEFL 550 (213 CBT) or equivalent for overseas students. The part-time pathway requires a MSc/Mphil/MRes and ...
MS and Graduate Certificate in Regulatory Science
The Master of Science (MS) and Graduate Certificate in Regulatory Science programs focus on drugs and biologics, although aspects of diagnostics, devices, and nutritional products are also addressed. The Graduate Certificate in Regulatory Science provides a more limited course of study than the MS degree program. Watch this two-minute video to ...
Graduate Certificate in Regulatory Sciences
The UAMS Regulatory Sciences program is a campus-wide initiative involving the Colleges of Medicine, Pharmacy, and Public Health, offered through the UAMS Graduate School and administered by the Department of Environmental Health Sciences. To learn more about our Regulatory Sciences program, call Christopher Fettes at 501-526-4260 or email ...
Regulatory Affairs & Quality Assurance
To receive our information packet, click here. Regulatory Affairs and Quality Assurance (RAQA) Graduate Program. 425 Commerce Drive, Suite 175. Fort Washington, PA 19034 Directions. Phone: 267-468-8560. E-Mail: [email protected].
PhD in Regulatory Affairs
PhD in Regulatory Affairs. TOPRA has a joint agreement for PhD students with the University of Hertfordshire (UH) looking to pursue a doctorate in Regulatory Affairs.. Duration of study for completing the PhD Full-time. This should be completed in no longer than four years - three years for the research plus one year allowed for writing the thesis.
Regulatory Science, MS
The MS program in regulatory science is designed for students interested in protecting public health through the discovery, development and marketing of medical products to the consumer. In particular, this program focuses on drugs and devices, preparing students for careers in the pharmaceutical, medical research and medical device industries.
MS in Regulatory Science
MS in Regulatory Science. The biomedical industry has grown rapidly, and this has fueled a large — and largely unmet — demand for regulatory professionals, both nationally and internationally. The USC Master's in Regulatory Science program arose to meet this growing need. As one of the nation's oldest and largest regulatory science ...
Drug Regulatory Science
Price. DKK 11,250 - DKK 14,050. Registration deadline. 23-09-2024. Apply. Regulation of medicines should be based on reliable science. With Regulatory Science we study both intentional as well as unintentional effects of drug regulation, regulatory instruments and regulatory decision-making, on drug development and innovation and on public health.
IMAGES
VIDEO
COMMENTS
Learn about the only doctoral program in regulatory science in the world, designed for advanced students who want to lead in the global medical products industry. The program combines research, leadership and inquiry skills with courses in strategic management, policy development and product lifecycle strategy.
Learn how to manage and lead in the regulated product industry with the first online DRSc program in the world. The program combines online and in-person courses, experiential learning and a thesis to prepare you for senior positions in government, academia and industry.
About the Program. The School of Pharmacy offers a graduate program leading to the PhD in Pharmaceutical Sciences with a concentration in Regulatory Affairs and Quality Assurance (RAQA). Emphasis is placed on combining scientific principles and methodology with regulatory and quality practices to streamline the discovery, manufacturing, safety ...
Mirroring the working environment of the industry, our programs emphasize collaborative problem-solving, communication, teamwork, cross-functional fluency and other soft skills essential for success in all aspects of regulatory and quality sciences—from shaping individual company strategies to ushering in systemic change to advance the entire profession.
Regulatory Science (DRSc) The Doctor of Regulatory Science program cultivates research, leadership and inquiry skills for advanced students in the emerging profession of global regulatory science. It is designed to produce graduates with expertise in strategic management, policy development and research assessment who can play leadership roles ...
The USC Doctorate of Regulatory Science degree requires satisfactory completion of 64 units beyond the baccalaureate degree, 4 of which are devoted to the writing of a thesis. Students with a master's degree may receive partial credit for coursework taken for a previous graduate degree. Program Structure The program is organized as a series of […]
Information about the two-year post-graduate Regulatory Pharmaceutical Fellowship program. This program is jointly sponsored by academia, industry, and government, and offers specialized ...
In 2018, Temple University School of Pharmacy established an RAQA PhD concentration within the Pharmaceutical Science doctoral program. This degree meets the needs of professionals working in regulated industry and various regulatory authorities, who have worked for decades in RA/QA and are highly accomplished experts seeking a doctoral degree ...
Admissions. To apply to the DRSc program, you must: Have completed a bachelor's degree with a minimum grade point average (GPA) of 3.0 from an accredited college or university.*. Submit three letters of recommendation from professionals or professors familiar with your capabilities and achievements. Submit a copy of your most up-to-date ...
Harvard, MIT, and the FDA have partnered to create a center focused on regulatory science, bringing together a range of scientific disciplines that are applied to assess the quality, safety and efficacy of medicinal products and inform regulatory decision-making throughout the lifecycle of a medicine. Working across academia, industry, and ...
Making a transition from a life and health science research scientist to regulatory affairs professional can be challenging. It is difficult to gain the requisite experience in an academic or industry research setting. However, the combination of an advanced science degree, transferable skills, and professional experiences can make this transition attainable.
Admission Requirements for the Doctorate of Science in Regulatory Science. The program is designed for individuals with strong professional experience and demonstrated intellectual and leadership capabilities. Applicants are expected to have a GPA of 3.0 on university-level course work and ten or more years of professional experience. Admission ...
MS in Regulatory Science Program Overview. A life-changing medical device. A time-saving, on-the-go meal. A revolutionary remedy. We live in a day of innovation - but a lot happens between idea and execution. Regulations exist at nearly every stage in R&D, from clinical trials to marketing. With advancing technology, developing consumer ...
In the first doctoral program to combine regulatory science with clinical research management, you'll learn about a leader's role in developing new medical products efficiently. In your courses, you'll hone your interpersonal, analytical, ethical and cultural competencies. You'll also build a knowledge base related to regulatory and ...
The Master of Science in Regulatory Science is an intensive, interdisciplinary program within the school designed to produce graduates whose backgrounds in biological, pharmaceutical, and biomedical sciences are enhanced by the knowledge and skills needed to manage regulated biomedical products. You can also read an FDA article "Why You ...
Doctor of Pharmacy/Master of Science, Regulatory Science (PharmD/MS) - USC. Updated: Thursday, August 15, at 6 a.m. PT. USC is a constellation of schools, centers and institutes where some of the brightest minds are leading the way to the future of education. USC, L.A. and California's southland are inextricably linked.
PhD Regulatory Science. Key information. School of study. School of Life and Medical Sciences. Entry requirements. An honours degree (normally at least 2:1 or above) in an appropriate discipline. IELTS entry requirement is normally 6.5, TOEFL 550 (213 CBT) or equivalent for overseas students. The part-time pathway requires a MSc/Mphil/MRes and ...
The Master of Science (MS) and Graduate Certificate in Regulatory Science programs focus on drugs and biologics, although aspects of diagnostics, devices, and nutritional products are also addressed. The Graduate Certificate in Regulatory Science provides a more limited course of study than the MS degree program. Watch this two-minute video to ...
The UAMS Regulatory Sciences program is a campus-wide initiative involving the Colleges of Medicine, Pharmacy, and Public Health, offered through the UAMS Graduate School and administered by the Department of Environmental Health Sciences. To learn more about our Regulatory Sciences program, call Christopher Fettes at 501-526-4260 or email ...
To receive our information packet, click here. Regulatory Affairs and Quality Assurance (RAQA) Graduate Program. 425 Commerce Drive, Suite 175. Fort Washington, PA 19034 Directions. Phone: 267-468-8560. E-Mail: [email protected].
PhD in Regulatory Affairs. TOPRA has a joint agreement for PhD students with the University of Hertfordshire (UH) looking to pursue a doctorate in Regulatory Affairs.. Duration of study for completing the PhD Full-time. This should be completed in no longer than four years - three years for the research plus one year allowed for writing the thesis.
The MS program in regulatory science is designed for students interested in protecting public health through the discovery, development and marketing of medical products to the consumer. In particular, this program focuses on drugs and devices, preparing students for careers in the pharmaceutical, medical research and medical device industries.
MS in Regulatory Science. The biomedical industry has grown rapidly, and this has fueled a large — and largely unmet — demand for regulatory professionals, both nationally and internationally. The USC Master's in Regulatory Science program arose to meet this growing need. As one of the nation's oldest and largest regulatory science ...
Price. DKK 11,250 - DKK 14,050. Registration deadline. 23-09-2024. Apply. Regulation of medicines should be based on reliable science. With Regulatory Science we study both intentional as well as unintentional effects of drug regulation, regulatory instruments and regulatory decision-making, on drug development and innovation and on public health.