In this certificate program, student explore the regulatory issues unique to biologics and biosimilar drug manufacturers, including all of the challenges in the path to global commercialization of a biological product. Coursework also includes:
- An overview of current regulatory and technical issues involved in developing biological products in major ICH regions
- The principles guiding the development of biosimilar drugs and how it differs from innovator drug development
- How biologics and biosimilars differ from chemically synthesized drugs
- Discovering analytical methods for characterizing biologics, including how analytical testing differs from small molecule testing
- Understanding quality by design principles that relate to development, manufacturing and testing of biologics
This five course certificate delves into the requirements of major ICH markets for biologics and biosimilar products. The certificate builds a strong foundation in the biologics and biosimilar regulatory landscape and exposes students to key trends and controversies facing the biologics and biosimilar industry. It enables students to become fluent in the methods used in the discovery of biopharmaceutical products, including materials sourcing and testing requirements, 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:
- 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)
We offer two certificates in biologics and biosimilars. If you are looking for a program with a greater emphasis on regulatory aspects related to biologics and biosimilars, review our Certificate in Biologics and Biosimilars: Manufacturing.
All courses may be completed online. The GRE is not required for the Biologics and Biosimilars: Regulatory Aspects 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