With Kenneth Surowitz Ph.D. - October 28 - 31
Next Course Date
October 28 - 31, 2024 Live Streamed Classroom 12:00 to 5:00 ET / 9:00 to 2:00 PT | |
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Course runs 12:00 to 5:00 ET / 9:00 to 2:00 PT This course will introduce the attendee to the historical development of vaccines, the different types (classes) of vaccines in use today, and will orient the attendee to the laws (PHSA, FD&CA) and regulations (ICH, FDA Guidance’s) required for vaccine development and commercialization. The separate roles of FDA and CDC in the US will be discussed, and the regulatory pathways for marketing authorization (MAA) of vaccines in the EU will be presented. |
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At the end of the three-day course attendees will: - Gain a solid understanding of the regulatory framework for vaccines for prophylactic (infectious disease) and therapeutic indications, incidents that have prompted regulation, and an understanding of the differences and commonalities of vaccine regulation versus small molecule drugs and other biologics.
- Understand the structure of CBER within FDA and its historical evolution, and the processes in place in EU for review and authorization of new vaccines.
- Understand the fundamental bioprocess steps in production of bacterial and viral (cell-based) vaccines and control testing requirements/strategies, including a basic understanding of Master Cell Banks, Master Viral Seeds, upstream and downstream processes, and testing/characterization of process- and product-related impurities and adventitious agents.
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| Dr. Surowitz has served for 10 years as Adjunct Associate Professor in the Regulatory Affairs and Quality Assurance graduate program at the Temple University College of Pharmacy. He currently teaches a graduate degree course on “Vaccines: Regulatory and Quality Issues,” having previously taught a graduate course on “CMC for Biological Products”. |
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