Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy
Post-Master's Certificate in
Biosimilars and Generic Drugs
Brochure on the Post-Master's Certificate in Biopharmaceuticals and Generic Drugs
- Graduates of our MS in RAQA degree are welcome to complete the Post-Master’s Certificate in Biosimilars and Generic Drugs.
- Four courses beyond the MS are required to receive this Certificate. One of the courses must be 5483. If that course was already completed as part of the MS, the student may substitute another course from the list of accepted courses below.
- Courses taken for the completion of the MS degree will not be counted.
- Students must apply for the Certificate before taking any courses: Application.
Only the following courses may be taken towards completion of the program:
- Generic Drug Regulation: ANDAs (5483)
- The Global Biopharmaceutical Industry (including Waxman Hatch) (5458)
- Pharmaceutical Manufacturing II (8004)
- Good Distribution Practices (5543)
- Biologics/Biosimilars (5515)
- Analytical Chemistry in Pharmaceutical Laboratories (5655)
- Global Pharmaceutical Excipient Regulation (5546)
- Global CMCs for Biopharmaceuticals (5577)
Transfer credits are not accepted towards Temple’s certificate programs. Students may receive more than one post-master's certificate.
Masterís Students from Other Accredited Schools in the U.S.
If you did not receive the MS in RAQA from Temple University, you are required to complete five approved courses to receive the Post Master's Certificate in Biosimilars and Generic Drugs. Please refer to the Brochure regarding course choices.
You must have sufficient industry experience and demonstrated familiarity with basic tenets of RAQA to pursue the Temple U Post Master's Certificate in Biosimilars and Generic Drugs.
You must apply before starting the program: Application, including a letter of request to the Assistant Dean of RAQA, which indicates which courses you intend to pursue and citing your industry experience.
Include a copy of your resume and a photocopy of your final transcript from the school where you received your doctoral or master's degree.
Send all application materials to:
Temple University RAQA Graduate Program
Attn: Assistant Dean
425 Commerce Drive, Ste 175
Fort Washington, PA 19034
Formal permission to pursue the Post-Master's Certificate in Biosimilars and Generic Drugs must be received from the Assistant Dean before the student starts any courses in the Advanced Certificate program.
How to Obtain the Certificate when all courses have been completed:
Submit the Notice of Completion to the RAQA Office (hard copy only) by the stipulated deadlines (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you will have to wait until the next time certificates are issued. Certificates will be mailed to your home in late February, late June, or late September.