This five-course Generic Drug Certificate focuses on the development processes and domestic and global regulations of the generic drug industry. Courses explore the drug development process, global marketplace for generic drugs, and how to build a strong foundation in generic regulatory issues, including the ANDA process.
Two courses are required:
- Drug Development (5459)
- Generic Drug Regulation: ANDAs (5473)
And students choose three course electives:
- The Global Biopharmaceutical Industry (5458)
- Validation of FUE (Facilities, Utilities, and Equipment) (5468)
- Drug Dosage Forms (5499) or Solid Dosage Forms – Small Molecules (8004)
- Active Pharmaceutical Ingredients (APIs) (5513)
- Regulatory eSubmissions (5514)
- Good Distribution Practices (Pharmaceutics 5543)
- Global Pharmaceutical Excipient Regulation (5546)
- Pharmaceutical Quality Management Systems (5574)
- Global CMC Issues and Regulatory Dossiers (5576)
- Analytical Chemistry in Pharmaceutical Laboratories (5655)
- Special Topics: Current Issues Affecting the Generic Drug Industry (5650)
If students already completed the required courses as part of the MS in RAQA, they may substitute electives from the list above.
The Post-Master’s Certificate in Generic Drugs may be earned on its own or on the way to the MS in RAQA. To earn the certificate, five courses must be successfully completed within a four year period with an overall B (3.0) average.
Application Information for RAQA Post-Master's Certificates
Applying is straight-forward and convenient, with Temple's Online Graduate Application Portal.
Application Process for RAQA Post-Master's Certificates
- Contact the RAQA office to speak with a program representative
- Set up an account on our Graduate Application Portal. Once you complete the form, you will receive an email to complete your set up.
- Complete all of the required personal information in the Application Portal.
- Submit all required documents, as listed below.
Once all documents have been received, your application will be submitted to our review panel for evaluation. A representative will be in touch within a week of submitting your application with a timeline for an admissions decision.
Application Requirements for RAQA Post-Master's Certificates
- A master’s degree in a pharmacy-related field and a bachelor of science degree in biology, chemistry, engineering, pharmacy, physics or related fields
- Applicants who earned a degree at a non-U.S. institution must submit an equivalency evaluation of their transcript(s) through a third-party provider, either World Education Services (WES) or Educational Credential Evaluators (ECE).
- You must apply before starting the program on the Graduate Application Portal.
- Transcripts: Transcripts from all post-secondary institutions attended may be sent electronically to qara@temple.edu. Alternately, unopened official transcripts bearing the school's seal must be sent directly from the Registrar at each institution to the School of Pharmacy.
- Resume: Current resume or CV is required.
- Statement of Goals: In approximately 500 to 1,000 words, applicants should state their specific interest in Temple's program, research goals, future career goals, and academic and research achievements. It should also indicate which courses you would like to pursue, cite your industry experience, and include at least two alternate courses to allow for greater scheduling flexibility.
- Standardized Test Scores: Applicants who earned their master's degree from an institution where the language of instruction was other than English, must report scores for a standardized test of English that meet these minimums:
- TOEFL iBT: 85
- Some certificates require proof of work experience in RAQA or Biosimilar Manufacturing. Please contact the RAQA Program Office for specific details.
Questions?
Contact our office directly to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.