Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance.

Information regarding chemistry, manufacturing and controls (CMC) for drugs is an important and detailed section in the dossier to support clinical studies and marketing applications. This data must be updated as more information is gained throughout a drug’s lifecycle.

The quality module of the Common Technical Document (CTD) presents the CMC data in the submission dossier for small and large molecules. Compiling the CMC regulatory material is challenging; however this needs to be completed with efficiency and accuracy to gain fast approval.

This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

This is a key opportunity to learn from an expert in the field of CMC requirements and compliance, and discuss the complexities involved.

Please note, it is recommended that attendees have some experience with Module 3 of the CTD.