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

Description

The Regulatory Requirements across the Product Development Lifecycle (Part of Biotherapeutics Analytical Summit) covers topics such as:

  • The Product Development Timeline from IND to Commercialization
  • The Evolution of Drug Compliance in the US FDA Structure and Function
  • Good Manufacturing Practice
  • Good Laboratory Practice
  • The CMC Section of the Initial IND
  • Compliance across the Product Development Lifecycle
  • Meetings with FDA during D

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