Module 3 Presentations

07/05/2024

RA-CMC Team: An Integrated Approach And Interface Function

 Bridges local Operations/Quality with global Functions and Market Supply  Is the Quality Liaison between Global Regulatory Affairs (GRA), and local GMP Operations to ensure Regulatory Compliance  Enables efficient Communication and Decision-making related to the Quality of our Products (Product Q Oversight)  Addresses market-specific Requirements/Procedures at the local Manufacturing Site  Reduces Risks for Market Supply and Quality Incidents  Supports new Business Cases for new Transfers, Supply chain, and Planning FY23 M1 & 3 Updates Variations 69 302

Dossier Checks

GMP Site renewals 8

MAT and TTs 32

>260

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

7

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

8