Join us!
This workshop will present case studies based on selected collaborations, highlighting a science and risk-based approach to foster effective manufacturing changes and improvements. In addition, the filing of a post-approval change management protocol (PACMP), also known as a comparability protocol in the U.S.A., will be reviewed for different scenarios.
By the end of this workshop, participants will further understand the procedures and criteria for the appropriate risk categorization and reporting of changes, along with the data required to enable national regulatory agencies to evaluate the potential impact of the change on drug product quality, safety, and efficacy.
RAPS Workshop: Implement Efficient Changes to Approved Biologic Manufacturing and Controls Using Risk-Based Regulatory Approaches
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Robin Crawford
Education Specialist II
RAPS - ENTERPRISE
Rockville MD
United States
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