Post Approval Changes in Biologics Manufacturing

Available since March 2020
Janmeet Anant, Ph.D & Guido Kremer-van der Kamp (Merck)

This is a practical assessment guide on a Post-Approval Changes analysis from the supplier’s perspective on the real regulatory constraints and intents, with support of benefit-risk case studies in vaccine manufacturing.

In this course, it will cover:

• An understanding of the real regulatory constraints and intents
• Guidance and case studies that will help clarify critical factors for decision making
• Detailing conditions to be fulfilled and supporting documentation needed for specific cases