Description: This session will introduce common CMC changes which can impact on product quality and outline the potential of post-approval change management protocol (PACMPs) in optimising the regulatory process for introducing such changes. The session will describe a recently submitted case study of a global PACMP for a biological drug product, and include an overview of an ICH Q9 risk assessment in the process. Lastly, the session will provide the regulator viewpoint of post-approval regulatory strategy.
Learning Objectives:
Identify the challenges and complexities of global CMC regulatory strategy for post-approval changes throughout the Life-Cycle Management of the biological drug product.
Understand the procedures and criteria for the appropriate post-approval change categorization and reporting (including carrying out an ICH Q9 risk assessment).
Gain a working knowledge of global regulatory agencies' requirements to evaluate the potential impact of post-approval changes on drug product quality, safety, and efficacy.
