Global Regulatory Affairs in Drug Development : Online


Why study Global Regulatory Affairs in Drug Development : Online?

The development of new drugs, including biological therapeutic agents and devices is a multifaceted, complex and expensive process. It is estimated that the development of a new drug after initial stages of discovery, can take up to 15 years and cost up to $2 billion dollars. The Pharmaceutical industry in under unpresented pressure to reduce the time to market and to reduce the cost of research and development. 

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.

Admission Requirements

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. Similarly, applicants with a completed professional degree such as a PharmD, MD, or DVM meet eligibility requirements. Apply to the Global Regulatory Affairs in Drug Development Certificate Program.

Programmatic minimum admission criteria include:
  • A U.S. bachelors degree from a regionally accredited college or university or an equivalent degree from foreign country.
  • A grade-point average (GPA) of at least 3.00 or foreign equivalent.
  • If English is not your native language, a Test of English as a Foreign Language (TOEFL) of at least 90 (internet-based) or 235 (computer-based) is required.

Supplemental Application Documents

Consideration for admission requires completion of a University Graduate Application and electronic submission the following documents:

  • Curriculum
  • Statement of Purpose (Why do you plan to pursue a research-intensive PhD degree in Pharmaceutical Sciences at the University of Cincinnati? What is your desired research focus area within the broad field of Pharmaceutical Sciences? 

Transcript Information

All college transcripts with evidence of high academic achievement (undergraduate and graduate if applicable; unofficial transcript is sufficient for initial review process).

Unofficial transcripts are sufficient to make offers of admission. However, all official and final transcripts must be received by the Graduate School by 30 days before the start of class enrollment to secure admission offer.

Official transcripts may be submitted with your application and sent to:

University of Cincinnati
Graduate School
110 Van Wormer Circle
Pox Office Box 00627
Cincinnati, Oho 45221-037

Letters of Recommendation

Two letters of recommendation are required, three are preferred. (Applicants are encouraged to seek letters from individuals who can comment on research experience). Letters of recommendation from family, friends, current students, politicians, or clergy are not accepted.

Non-Matriculated Students

If you are interested in exploring Pharmaceutical Sciences graduate-level courses without formal matriculation, please complete the basic data form.

The graduates of this certificate program are likely to find suitable jobs in the following:

  • Companies developing pharmaceutical/biopharmaceutical and devices.

  • Contract research organizations that participate in pre-clinical (ADMET) and clinical trials.

  • Contract laboratories involved in pre-clinical formulations and development of drug delivery systems.

  • Companies involved in bioanalytical and testing of drug products.

  • Contract manufacturing facilities such as those involved in pharmaceutical product manufacturing as well as specialized packaging for example the special needs for double trials. 

  • Academic Health Centers and Research Institutions and community-based research groups.

Depending on the student's academic and professional background, the acquired knowledge and skills will equip student to start or advance their career: 

  • Those with BS degree may find an entry level position such in the above-indicate companies, either as research assistants and/or quality assurance/regulatory guides. Those with relatively advanced degrees (MBAs) will have opportunities to serve as Project Managers.

  • Those with specific scientific skills (Pharm D, MS, Ph.D., Post-Docs) may serve as scientific leads or project leaders depending on their areas of expertise and experience. Specialized opportunities - in the current economic climate our recent experience suggests that some of the basic scientists working in the academic settings (primarily as post-docs) seek such opportunities to transition to an industry career, where they may be involved as: 

    • Therapeutic experts

    • Medical writers

    • Medical Liaison 

  • Serve as consultants specializing in the development and testing of generics, biogenerics, sustained release formulations and fixed dose combinations. 

The Certificate program faculty and program advisors will communicate all course descriptions and requirements to the students about the Global Regulatoray Affairs in Drug Development Certificate program.
UC James L. Winkle College of Pharmacy faculty have a strong track record of research and mentoring in drug development research (molecular pharmacology, biomarkers, pharmacokinetics, drug safety (including mechanistic bases for drug-drug interactions/adverse drug reactions), and formulation of novel drugs.
Students must complete (4) courses and 12 credit hours in order to graduate with a certificate in Global Regulatory Affairs in Drug Development.
Students are eligible to transfer to the program from other colleges or universities. Transfer credits will based on course equivalency and are viewed on a  case-by-case basis after reviewing the approved transcript.
If English is not your native language, a Test of English as a Foreign Language (TOEFL) of at least 90 (internet-based) or 235 (computer-based) is required.

Application Deadlines

Graduate Certificate applications will be reviewed year-round and admission offered for the spring or fall semesters.
The University of Cincinnati and all regional campuses are accredited by the Higher Learning Commission.

Contact Information

Bingfang Yan
231 Albert Sabin Way
3205 Medical Sciences Building
Cincinnati, OH 45229
(513) 558-6172

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Program Code: 25GC-GRDD-GC-.GRDD-DL