This five-course Generic Drug Certificate focuses on the development processes and domestic and global regulations of the generic drug industry. The certificate focuses on key areas: the business environment, domestic and global regulations for generic products, manufacturing processes and science, and distribution practices.
Two courses are required:
- Drug Development (5459)
- Generic Drug Regulation: ANDAs (5473)
And choose three courses electives:
- The Global Biopharmaceutical Industry (5458)
- Drug Dosage Forms (5499) OR Solid Dosage Forms - Small Molecules (8004) (previously Pharmaceutical Manufacturing II)
- Active Pharmaceutical Ingredients (APIs) (5513)
- Good Distribution Practices (5543)
- Global Pharmaceutical Excipient Regulation (5546)
- Global CMC Issues and Regulatory Dossiers (5576)
- Analytical Chemistry in Pharmaceutical Laboratories (5655)
- Special Topics: Current Topics Affecting the Generic Drug Industry (5650)
Application Information for RAQA Pre-Master's Certificates
Applying is straight-forward and convenient, with Temple's Online Graduate Application Portal.
- Call the RAQA office at 267-468-8560 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.
- A baccalaureate degree, with an undergraduate GPA of 3.0 or higher.
- Transcripts: Transcripts from all post-secondary institutions attended may be sent electronically to [click-for-email]. Alternately, unopened official transcripts bearing the school's seal must be sent directly from the Registrar at each institution to the School of Pharmacy.
- 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).
- 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.
- Standardized Test Scores: Applicants who earned their baccalaureate degree from an institution where the language of instruction was other than English, with the exception of those who subsequently earned a master's degree at a U.S. institution, must report scores for a standardized test of English that meet these minimums:
- TOEFL iBT: 85
Questions?
Reach out to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.
Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance
425 Commerce Drive, Suite 175
Fort Washington, PA 19034
267-468-8650
QARA@temple.edu