Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)
Gowri Sukumar is an Associate Director, CMC and Regulatory Affairs for ESSA Pharmaceuticals. Unique to her experience is leading all the technical disciplines of CMC development as well as Regulatory Affairs. She has broad responsibilities that include process development, Drug Substance, and Drug Product manufacturing from the CMC side. From the Regulatory affairs perspective, she provides regulatory leadership and expertise for regulatory strategy, liaises with the regulatory agencies including FDA, EMA and other Health authorities. For her leadership approach, she brings a strong focus beyond the necessary technical disciplines and regulations, looking at the interplay of culture and teamwork for successfully advancing programs in an effective and efficient manner. Gowri holds a master’s Degree in Biosciences as well as the prestigious Regulatory Affairs Certification (RAC) awarded by the Regulatory Affairs Professional Society. She is the author or co-author of several peer-reviewed research publications as well as book chapters. Gowri has a breadth of experience spanning R&D, CMC, and Regulatory affairs. She also serves as a reviewer for several international Bioscience Journals for providing Scientific and technical expertise.
This webinar is designed to help pharma companies through the various key aspects of the Chemistry Manufacturing and Controls (CMC) information expected by FDA in an IND (Investigational New Drug) Application. The presentation will cover the key aspects of CMC package. And will explore the individual requirements across both the Drug Substance as well as the Drug Product sections of the CMC package.
- Outline of the relevance of information from the CMC perspective
- Understanding differences between small molecules and Biologics
- The glimpse of CFR 312.22 with the highlight of the FDA’s primary objectives in reviewing an IND
- Overview of Pre-IND activities
- CMC package: IND content and Format with emphasis on the Drug Substance and Drug Product
Who Should Attend
- Regulatory affairs professionals
- Senior management executives (CEO, COO, CFO, etc)
- Drug discovery and development professionals (R&D and CMC)
- Intellectual property experts
- Project Managers and Clinical trial specialists
- Regulatory Compliance Associates and Managers
- People investing in FDA-regulated product development projects