CMC Primer explores the essential considerations in drug development known as Chemistry, Manufacturing, and Controls (CMC). It starts by explaining the critical importance of CMC implementation using the Common Technical Document to ensure patient safety. The course then analyzes in detail the significance of CMC across every stage of drug development, from discovery to preclinical and clinical development, ending with post-launch considerations. Furthermore, CMC Primer focuses on the key aspects of CMC, such as Chemistry, Manufacturing, and Controls, through three practical case studies. The course ends by showcasing CMC's regulatory implications, post approval measures, and common challenges encountered in the field. Enroll today and gain insight into CMC's pivotal role in drug development, manufacturing, and patient safety.
Read More