Baltimore Events

Regulatory Requirements across the Product Development Lifecycle (Part of Biotherapeutics Analytical Summit 2018)


Mar 15 - Mar 16, 2018 – All Day

300 South Charles Street
Baltimore, MD 21201 Map

More Info

Introduction/Objective of the Seminar:
The successful development of a pharmaceutical product requires not only good science, but also compliance with FDA regulatory expectations. This course will include a comprehensive review of the Chemistry, Manufacturing and Controls (CMC) section of regulatory filings, with a focus on phase appropriate requirements. The level of detail that must be included in the filing will be discussed as well as systems and controls that must be in place in the manufacturing setting. Topics such as process development, analytical development, Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) will be discussed in the context of the stage of drug development. Regulatory strategies for navigating the path to approval will also be discussed. This course is intended to provide participants from all facets of the pharmaceutical and biotech industry with a broad understanding of regulatory requirements across the product development lifecycle.

The Seminar Will Cover:
• The Evolution of Drug Compliance in the US
FDA Structure and Function
• The Product Development Timeline from IND to Commercialization
• Good Laboratory Practice
• Good Manufacturing Practice
• Compliance across the Product Development Lifecycle
• The CMC Section of the Initial IND
• Meetings with FDA during Drug Development
• The BLA, NDA and Beyond

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