CMC Primer
*This microcourse includes optional CPE Credits and is powered by Biotech Primer, a trusted leader in life science training that simplifies complex topics for non-scientists.
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Optional CPE Credit: 1.0
Overview:
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.
- Section 1: CMC Drug Development: Considerations Gain a comprehensive understanding of Chemistry, Manufacturing, and Controls (CMC) in the pharmaceutical industry. By examining the interplay between chemistry, manufacturing, and controls, you’ll grasp how each contributes to pharmaceutical development and regulation. You’ll also learn about the importance of CMC data within the Common Technical Document (CTD) for regulatory compliance. This knowledge equips you to navigate CMC effectively, contributing to pharmaceutical innovation and patient care.
- Section 2: CMC In Action: Explore Chemistry, Manufacturing, and Controls (CMC) in pharmaceuticals. You’ll learn about the specific evaluations in Chemistry for drug purity and stability, Manufacturing’s role in quality and compliance, and Controls’ importance for product efficacy and safety. By understanding these elements, you’ll grasp CMC’s vital role in pharmaceutical product lifecycle and industry standards.
- Section 3: CMC Regulatory Considerations: Master the critical significance of Chemistry, Manufacturing, and Controls (CMC) from both regulatory and industry perspectives in this section. Discover how CMC data is pivotal in ensuring product quality, safety, and regulatory compliance during the submission process, as well as its role in continuous post-marketing surveillance.
By the end of the course, participants will be able to:
- 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.
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