Translational Research: Regulatory Science, Certificate

Penn offers three certificates in Translational Research: the Certificate in Translational Science, the Certificate in Entrepreneurial Science, or the Certificate in Regulatory Science. The Certificate in Regulatory Science is designed for PhD scientists who wish to pursue Regulatory Science careers in academia, the pharmaceutical and biotechnology industry, the consulting and legal industries, and federal agencies.  

The certificate can be finished in one year and must be completed within two years. 

Curriculum

The certificate requires the completion of 4 course units with a passing grade of B- or better. 

Plan of Study Grid
First Year
FallCourse Units
REG 5100 Introduction to Clinical and Translational Research 1
REG 6100 Fundamentals of FDA Regulation 1.0
 Course Units2.00
Spring
Select 2 electives from the following: 2
Clinical Study Management  
Introduction to Drug Development  
Biopharmaceutical Product Development, Manufacturing and Regulatory Affairs  
Cell and Gene Therapy  
New Trends in Medicine and Vaccine Discovery  
Medicinal Chemistry and Drug Design  
Nanoscale Science and Engineering  
Other Electives 2
 
 Course Units2.00
 Total Course Units4.00
1

Other biostatistics courses may be substituted if taken in the past two years with a grade of B- or better.

2

Students may take elective courses outside of these recommendations, by substituting a different MTR/REG course or a course outside of MTR/REG, but must obtain permission before enrolling.

Research Project

The certificate requires a one-year engagement in clinical and translational research. This will take the form of a new research project or as a translational arm to research currently being conducted. Prospective students will identify a mentor and define the research project at the time of application.


The degree and major requirements displayed are intended as a guide for students entering in the Fall of 2022 and later. Students should consult with their academic program regarding final certifications and requirements for graduation.