Certificate in Regulatory Science

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Regulatory Science

The Certificate in Regulatory Science program is intended to meet the needs of the Penn Medicine community. This program is designed for PhD scientists who wish to pursue Regulatory Science careers in academia, the pharmaceutical & biotechnology industry, the consulting and legal industries, and federal agencies.

Pre-doctoral PhD students are encouraged to apply to the certificate and associated training grant. The CTSA TL1 award provides one year of funding including tuition and a stipend per NIH policy. The tuition funding will cover the cost of the certificate.

Curriculum Includes: 


The coursework provides students with training to build upon their scientific expertise and prepares them to understand regulatory strategy, the execution of clinical trials, and approaches to translate early discoveries and preclinical investigations into therapeutics. Students will learn the skills necessary to apply contemporary research methods to develop new tools, standards, and approaches to assess the efficacy, quality, and performance of FDA-regulated products. 

Certificate in Regulatory Science Courses

Required Courses Electives
  • REG 510 Intro to Clinical & Translational Research
  • REG 610 Fundamentals of FDA Regulations
  • 2 Electives
  • REG 618 Introduction to Vaccine Development
  • REG 611 Clinical Study Management
  • REG 624 Applied Regulatory Processes of Vaccines and Biologics
  • REG 612 Intro to Drug Development
  • REG 621 Cell & Gene Therapy
  • REG 622 New Trends in Medicine & Vaccine Discovery
  • REG 625 Challenges and Controversies in Academic Biomanufacturing 
  • CHEM 742 Medical Chemistry & Drug Decision

The Certificate Program can be finished in one year and must be completed within two years. The certificate requires the completion of 4 credit units, with a passing grade of B- or better. Should a student wish to proceed onto the Master of Science in Regulatory Science the course work will count towards the degree.

If a student is interested in an elective that is not on the list, approval must be obtained from the Certificate Director.

Research Project

The certificate requires a one-year engagement in a regulatory science research project. This will take the form of a new research project or as an additional arm to research currently being conducted. If the student is already engaged in regulatory science an additional research project is not required. Prospective students will identify a mentor and define the research project at the time of application.