Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy
Biosimilars and Generic Drug Certificate (Pre-Master's)
This five-course Biosimilars and Generic Drug Certificate focuses on the development processes and regulations of the biosimilar and generic drug industry. The certificate focuses on key areas: the global business environment, domestic and global regulations for generic products, manufacturing science, and business distribution practices.
Two courses are required:
Drug Development (5459)
Generic Drug Regulation: ANDAs (5473)
Three courses are electives of the student's choosing:
- The Global Biopharmaceutical Industry (5458)
- Pharmaceutical Manufacturing II (8004)
- Good Distribution Practices (5543)
- Biologics/Biosimilars: A Regulatory Overview (5515)
- Global Pharmaceutical Excipient Regulation (5546)
- Global CMCs - Biologics (5577)
- Analytical Chemistry in Pharmaceutical Laboratories (5655)
Transfer credits are not accepted towards Temple’s certificate programs.
Brochure - Certificate in Biosimilars and Generic Drugs
How to Receive the Certificate when you've completed the courses.
Submit the following items to the RAQA Office (hard copy only).
2. Photocopies of your undergraduate and graduate transcripts.
3. A transcript from Temple's Banner system of courses taken in the RAQA program.
4. Notice of Completion
All materials must be received 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.
Note: Students may obtain only one certificate before completing the MS program, except for Food RA and QA.