Available at Pre- and Post-Master’s Levels

Pre-Master’s Certificate in Biosimilars and Generic Drugs

This certificate focuses on the burgeoning biosimilar 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.

The certificate consists of five courses, which must be completed in four years with an overall B average.

Two courses are required:

• Drug Development (5459)
• Generic Drug Regulation: ANDAs (5473).

Students may choose the remaining three courses from the following accepted electives:

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

Brochure
Application Form
Notice of Completion

Post-Master’s Certificate in Biosimlars and Generic Drugs

Students who have received the M.S. in RAQA are eligible to complete the Post-Master’s Certificate in Biosimilars 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 Biosimilars and Generic Drugs.  One of the courses must be Generic Drug Regulation: ANDAs (5483), unless the student has already taken that course while completing the M.S. in RAQA. Then the student may substitute another course. The following courses may be taken towards completion of this program:

• Generic Drug Regulation: ANDAs (5483)
• The Global Biopharmaceutical Industry (5458)
• Pharmaceutical Manufacturing II (8004)
• Good Distribution Practices (5543)
• Biologics/Biosimilars:  A Regulatory Overview (5515)
• Global Pharmaceutical Excipient Regulation (5546)
• Analytical Chemistry in Pharmaceutical Laboratories (5655)
• Global CMCs for Biopharmaceuticals (5577)
• Special Topics courses focusing on Medical Device Topics (5650)

Brochure
Application
Post-M.S. Notice of Completion

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

To be eligible, students must write a letter to the Assistant Dean indicating the courses they wish to pursue.  Their program must be approved before registering for any courses.