Advanced Certificate in Biopharmaceuticals and Generic Drugs

Post-Master’s Certificate in Biopharmaceuticals and Generic Drugs

This certificate focuses on the burgeoning biopharmaceutical and generic drug industry (small molecules), familiarizing students with pertinent regulations, manufacturing science and distribution practices at the local, national and global levels. The courses focus on four key areas: the global business environment, domestic and global regulations for generic products, manufacturing science and business distribution practices.  Students are also exposed to major trends and controversies facing the generic industry: GIVE (Generic Initiative for Value and Efficiency), Citizen’s Petitions and Authorized Generics.

Students who have received the M.S. in QA/RA are eligible to complete the Post-Master’s Certificate in Biopharmaceuticals and Generic Drugs.  To receive the certificate, students need to take four additional courses beyond the M.S. (that were not previously taken when the student was pursing the master's degree.)  Courses taken for the completion of the M.S. degree will not be counted towards the Post-Master’s Certificate in Biopharmaceuticals and Generic Drugs.  One of the courses must be Generic Drug Regulation: ANDAs (Pharmaceutics 5483), unless the student has already taken that course while completing the M.S. in QA/RA. Then the student may substitute another course. The following courses may be taken towards completion of this program:

  • Generic Drug Regulation: ANDAs (Pharmaceutics 5483)
  • The Global Biopharmaceutical Industry (including Waxman Hatch) (Pharmaceutics 5458)
  • Pharmaceutical Manufacturing II (Pharmaceutics 8004)
  • Good Distribution Practices (Pharmaceutics 5543)
  • Biologics/Biosimilars:  A Regulatory Overview (Pharmaceutics 5515)
  • Global Pharmaceutical Excipient Regulation (Pharmaceutics 5546)
  • Analytical Chemistry in Pharmaceutical Laboratories (Pharmaceutics 5655)
  • Global CMCs for Biopharmaceuticals (Pharmaceutics 5577)

Post-M.S. Notice of Completion

This certificate is open to students who received their master's degrees from other schools; however, these individuals must start with the program with Drug Development (Pharmaceutics 5459) and also take Generic Drug Regulation:  ANDAs (Pharmaceutics 5483). Thus, they must complete five courses to receive the Post-Master's Certificate in Biopharmaceuticals and Generic Drugs.

To be eligible, students must write a letter to Assistant Dean Wendy Lebing indicating the courses they wish to prsue.  They must receive formal approval first before registering for any courses.