Online Certificate in Global Regulatory Affairs in Drug Development
Founded in 2014, the Global Regulatory Affairs in Drug Development Graduate Certificate provides individuals a formal opportunity to further their knowledge in regulatory affairs.
Global Regulatory Affairs in Drug Development Graduate Certificate Highlights
High Quality Education
The Global Regulatory Affairs in Drug Development certificate program is designed to provide biomedical students and professionals an opportunity to learn about the global regulatory framework within which all scientific activities and business strategies are pursued.
Along with our Global Regulatory Affairs in Drug Development certificate, we offer a Masters in Pharmaceutical Sciences with emphasis on Pharmaceutics/Drug Development as well as the Clinical Trials Design & Research certificate. These three options are all online, asynchronous and available to part-time and full-time students.
Flexibility
- 100% online
- Start in the fall, spring, or summer semester
- All credits taken as part of this certificate may be subsequently applied toward the Masters in Drug Development Sciences
Support from Application through Graduation
At UC, you’ll have a full support team behind you:
Enrollment Services Advisor: Your partner through the application process, getting enrolled, and starting your program
Student Success Coordinator: Helping you prepare for classes and stay on track
Access to Resources: Access to university resources that will support you through your program including online learning expectations and resources, health and wellness resources, and academic support
The online Global Regulatory Affairs in Drug Development certificate program is 12 credit hours and can be completed in 1 year. The program is designed to provide biomedical students and professionals an opportunity to learn about the global regulatory framework within which all scientific activities and business strategies are pursued.
| Course | Title/Description | Credit |
|---|---|---|
| PHDD8010 | Global Regulatory and Development Strategies of Drugs and Medical Devices This course provides graduate students with an overview on legal and regulatory aspects relevant to drug and medical device development. This includes intellectual properties protection, global legal and regulatory requirements, protection of human subjects and ethics in clinical research and essential elements of management of global projects. Case studies will be included to underline how regulatory strategiesimpact product marketing and life cycle management. Throughout the course, students will integrate knowledge using specific industry examples with the goal to identify critical decision points in the development that impact success of a new drug or medical device on the market. |
3 |
| PHDD8020 | Discovery of Drugs and Therapeutic Biologicals This course is an introduction to the discovery and early development (ie, prior to pre-clinical) of small molecule therapeutics and biopharmaceuticals such as proteins, peptides, vaccines, cell and gene therapies, and nucleotide based products. Introductions to the major classesand categories of drugs and biological will be provided including some principles of pharmacologysuch as drug targets/receptors and drug-receptor interactions. Methods and principles of drug/biologics discovery will be addressed from serendipitous observation to current approaches such as HTS, computational, combinatorial chemistry, and bioinformatics. Comparison of manufacturing methodology of drugs and biologics will be provided along with special clinical and regulatory considerations for biologic products. Additionally, emphasis will be given to major therapeutic areas (oncology, CNS, cardiovascular, Infectious Diseases/AIDS) in terms of approaches currently in use and in development along with addressing the unmet needs in each area. |
3 |
| PHDD8030 | Pre-Clinical/Non-Clinical Studies for IND Approval The course is designed to teach students regulatory framework for the pre-clinical evaluation of the safety and efficacy of a molecular entity/lead compound identified in the drug discovery/early development phases for submission of the IND application. Major emphasis will be placed on the principles of pharmacokinetics/toxicokinetics and ADME processes(Absorption, Distribution, Metabolism and Excretion) so that safe (and efficacious) dosing regimens can be recommended for the early clinicaldevelopment phases. Differences between conventional (small molecules) vs. macromolecules and biologicals will be underscored. |
3 |
| PHDD8040 | Development and Manufacturing of Drug Products and Medical Devices This course is designed to provide an understanding of the studies conducted in support of the development of drug product (formulation/dosage form) and medical devices necessary to seek regulatory approval. An emphasis will be placed on pre-formulation/formulation studies for optimizing lead compounds during early stages of drug development, current good manufacturing practices (cGMP) and FDA/ICH guidelines for formulation components, processes and equipment, stability testing programs and overall quality assurance. Special aspects of formulation of biologicals and medical devices will also be discussed. |
3 |
The Global Regulatory Affairs in Drug Development Graduate Certificate program is designed for students working in the scientific and regulatory and business aspects of drug development.
Students who have earned at least an undergraduate degree in chemistry, biology, engineering, or related disciplines from an accredited institution are eligible to apply for admission to the certificate program. Applicants with a completed professional degree such as a PharmD, MD, or DVM meet eligibility requirements.
Prerequisites
- A U.S. bachelors degree from a regionally accredited college or university or an equivalent degree from a foreign country
- A grade-point average (GPA) of at least 3.00 or foreign equivalent
- Some experience in drug development or clinical research
- For international students, a Test of English as a Foreign Language (TOEFL) of at least 90 (internet-based) or 235 (computer-based), or a Duolingo English Test of at least 110 is accepted.
- GRE is not required for the graduate certificate
Complete the online application and submit the application fee.
Standard Application Fees:
- $65.00 for domestic applicants to most degree programs
- $70.00 for international applicants to most degree programs
- $20.00 for domestic applicants to Graduate Certificates
- $25.00 for international applicants to Graduate Certificates
- Application fees are waived for Summer 2026 applications submitted by March 1st, 2026
- Application fees are waived for Fall 2026 applications submitted by July 1st, 2026
- Fee waivers are automatically applied for applicants who:
- are currently serving in the US armed forces
- are veterans of the US armed forces
All applicants are required to upload unofficial transcripts during the application process, showing all undergraduate and graduate course work completed, including degrees granted and dates of conferral.
Official transcripts are not required until the student has received and accepted an offer of admission from the university. Once the offer has been confirmed, the student must submit official transcripts.
Students who have received degrees from the University of Cincinnati do not need to submit official paper copies of their UC transcripts.
Transcripts can be submitted electronically or by mail. To see if your transcript(s) can be ordered electronically, visit the links below and search for your previous school(s).
- Parchment
- Please select “University of Cincinnati – Main Campus” as the recipient of your transcript.
- National Student Clearinghouse
- Please have your transcript sent directly to admissions@uc.edu.
If you do not see your past school(s) listed on either site, please contact the school(s) directly. Then, mail your sealed, unopened, official transcripts to:
Please mail sealed, unopened, official transcripts to:
University of Cincinnati
Office of Admissions
PO Box 210091
Cincinnati, Ohio 45221-0091
Two letters of reference are required.
References should come from individuals who can attest to your academic and professional skills. Letters of recommendation from family, friends, current students, politicians, or clergy are not accepted.
A professional and current resume.
Provide a few paragraphs on why you plan to pursue this program and how you plan to use this degree in the future.
| Term | Application Deadline | Classes Start |
|---|---|---|
Summer 2026 Fall 2026 Spring 2027 |
April 1, 2026 August 1, 2026 December 1, 2026 |
May 11, 2026 August 24, 2026 January 11, 2027 |
The University of Cincinnati's online course fees differ depending on the program. On average, students will accrue fewer fees than students attending on-campus classes.
The one fee applied across all UC Online programs is the distance learning fee. Students living outside the state of Ohio must also pay an additional “non-resident” fee to enroll in courses at UC Online. This fee is lower than the out-of-state fee for traditional on-campus programs.
To view tuition information and program costs, visit the Online Program Fees page.
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We offer over 130 degrees from undergraduate to doctoral programs. Each program is supported by a team of Enrollment Services Advisors (ESAs) who are here to help answer any questions you have.