BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
CMC Primer
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.
Takeaways
- Discuss the purpose of CMC in drug development and manufacturing.
- List the three CMC components and provide an in-depth explanation of their focus.
- Specify what CMC data is found in the Common Technical Document (CTD) and its importance.
- State three reasons CMC is critical to patient safety.
- Identify and compare Control studies for CMC, including the study establishing drug product shelf life and studying degradation over time.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher