Temple offers two post-Master's certificates in Biologics and Biosimilars. This program places a greater emphasis on the regulatory aspects unique to biologics and biosimilars, including:
- Clinical, manufacturing, regulatory, and strategic issues that challenge the path to global commercialization of a biological product
- Current regulatory and technical/scientific issues involved in developing biological products in major ICH regions
- Guiding principals in the development of biosimilar drugs and how they differ from innovator drug development
- Differences between biologics and biosimilars and chemically synthesized drugs
- Analytical methods that are used to characterize biologics
- How analytical testing differs from small molecule testing
- Quality by Design principles and their relation to development, manufacturing, and testing of biologics
This five course certificate delves into the requirements of major ICH markets for biologics and biosimilar products. It builds a strong foundation in the biologics and biosimilar regulatory landscape and exposes students to key trends and controversies facing the industry. The program enables students to become fluent in the methods used in the discovery of biopharmaceutical products, including materials sourcing and testing requirements, and the technologies and unique considerations associated with the manufacture of biopharmaceutical products.
Students must complete three required courses:
- Drug Development (RAQA 5459)
- Biologics/Biosimilars: A Regulatory Overview (RAQA 5515)
- Global CMCs – Biopharmaceuticals and Other Biologics (RAQA 5577)
And choose two electives from the following:
- Production of Sterile Products (RAQA 5492)
- Regulatory eSubmissions (RAQA 5514)
- Clinical Drug Safety and Pharmacovigilance (RAQA 5538) OR RAQA 5571)
- Special Topics in RAQA - Current Trends in Clinical Trials (RAQA 5560)
- Post-Marketing Safety Surveillance (RAQA 5571) OR RAQA 5538
- Vaccines: RA and QA Issues (RAQA 5572)
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
- 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 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
- If you did not receive the MS in RAQA from Temple University, you are required to complete five approved courses to receive the Post-master's Certificate in Advanced RAQA.
- 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 have sufficient industry experience and sufficient familiarity with basic tenets of RAQA to pursue the post-master's certificate in Advanced RAQA.
- 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 [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.
- 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
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