Biosimilars and Generic Drugs Post-Master’s Certificate
Sharpen your knowledge, meet regulatory training requirements and stay current in a critical segment of the pharmaceutical industry with the Post-Master’s Certificate in Biosimilars and Generic Drugs in Temple’s School of Pharmacy. This graduate certificate is part of the School of Pharmacy’s Regulatory Affairs and Quality Assurance (RAQA) graduate program, which is based in Fort Washington, Pennsylvania, approximately 20 miles from Temple’s Health Sciences Center. Through courses offered in the evenings and on weekends, as well as classes available online, this certificate program is designed to fit your professional schedule.
You’ll form a comprehensive understanding of how generic drugs are manufactured and regulated locally, nationally and globally. Focus is also placed on the unique dynamics of generic drug distribution throughout the world.
Starting with an overview of the drug development process, the coursework explores the global marketplace for generic drugs and biopharmaceuticals. You’ll build a strong foundation in generic regulatory issues, including the Abbreviated New Drug Application (ANDA) process and distribution practices used domestically and worldwide. The courses also expose students to key trends and controversies facing the generic industry, such as
- GIVE (Generic Initiative for Value and Efficiency),
- Citizen’s Petitions, and
- Authorized Generics.
Classes & Curriculum
To receive the Post-Master’s Certificate in Biosimilars and Generic Drugs, students are required to complete five courses. Students who have already earned an MS in RAQA need only take four courses.
The following two courses are required for completion of the program:
- Generic Drug Regulation: ANDAs, covering the process by which generic drugs may obtain FDA approval based on an Abbreviated New Drug Application (ANDA). Drug Development (5459) is a prerequisite for taking Generic Drug Regulation: ANDAs.
- The Global Biopharmaceutical Industry (including Waxman Hatch), which studies the competitive and regulatory environment in which generic drugs are brought to market.
In addition, students may select some of the following courses.
- Pharmaceutical Manufacturing II
- Good Distribution Practices
- Biologics/ Biosimilars: A Regulatory Overview
- Global Pharmaceutical Excipient Regulation
- Analytical Chemistry in Pharmaceutical Laboratories
- CMCs for Biologics
Students are expected to complete the program within four years. See the full list of courses for the Post-Master’s Certificate in Biosimilars and Generic Drugs certificate.