Regulatory considerations for vaccine development: talk 1 - chemistry, manufacturing and control

Published on November 30, 2015   31 min

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Other Talks in the Series: Vaccines

Hello, my name is Norman Baylor. I'm the President and CEO of Biologics Consulting Group, Inc., a regulatory consulting firm based in the Washington DC area in the United States. I was formerly the Director of FDA's Office of Vaccines Research and Review. This talk is part 1 of a 2-part presentation on the US regulatory requirements. I will discuss in part 1 their considerations for chemistry, manufacturing, and controls of vaccine, commonly called the CMC section of the regulations. Dr. Lewis Schrager discussed the clinical regulatory considerations in part 2.
I outlined the presentation. I will discuss the organization and function of the Food and Drug Administration in the US and the Office of Vaccines Research and Review, which is responsible for the evaluation and marketing authorization for vaccines and related products. I will also cover the history and evolution of the regulations of vaccines in the United States. The legal framework for vaccine regulations, I'll define what a vaccine actually is from a regulatory perspective. I will discuss things to consider in manufacturing of vaccine under current good manufacturing practices. I'll also discuss preclinical evaluation, define process validation, and briefly mention new technology used in the developing of new generation vaccines.
The Food and Drug Administration's Center for Biologics Evaluation and Research, commonly called CBER, is a national regulatory authority in the United States responsible for assuring quality, safety, and effectiveness, of all human medical products including vaccines for human use. Vaccines are evaluated in CBER's Office of Vaccines Research Review. The Office of Vaccines Research Review is composed of two laboratory-based research divisions, the Division of Bacterial, Parasitic and Allergenic Products, and the Division of Viral Products. And there is also an applications division commonly called the Division of Vaccines and Related Products Applications where the clinical review of vaccine applications occurs.

Regulatory considerations for vaccine development: talk 1 - chemistry, manufacturing and control

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