Generic Drug Certificate (Pre-Master's) (RAQA)

Introduction to the Generic Drug Industry

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. 

Application Process for RAQA Pre-Master's Certificates
  1. Call the RAQA office at 267-468-8560 to speak with a program representative
  2. Set up an account on our Graduate Application Portal. Once you complete the form, you will receive an email to complete your set up. 
  3. Complete all of the required personal information in the Application Portal.
  4. 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 Pre-Master's Certificates
  • 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 . 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.
  • 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