The first biopharmaceutical product (recombinant human insulin) was approved in 1982. Since then, products derived through pharmaceutical biotechnology have provided medical advances that include therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors.
This five course certificate teaches the rigorous and highly complicated regulatory framework required for the approval of biotechnology-derived products (or biologics). The Pharmaceutical Manufacturing and RA Certificate delves into the complex regulations governing the development, manufacturing, and distribution of such products.
Required courses:
- Pharmaceutical Biotechnology (8005)
- Biotechnology: Bioprocess Basics (5471)
- CMCs - Biologics (5577)
- Biologics/Biosimilars: A Regulatory Overview (5515)
And one elective from the following:
- Production of Sterile Products (5492)
- Sterilization Processes (5493)
- Development of Sterile Products (5501)
- Microbiological Concepts in Pharmaceutical Manufacturing (5512)
- Vaccines: RA and QA Issues (5572)
- Regulatory Bioanalysis (5621)
All courses may be completed online. The GRE is not required for the Biopharmaceutical Manufacturing and Regulatory Affairs Certificate. Students may obtain only one certificate before completing the MS program, except for Food RA and QA.
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
- 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.
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 [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