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SUMMARY:
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DS InPharmatics Senior Regulatory Affairs Consultant, Dr. Catherine Bernard joins the show to share her experience in regulatory affairs in the pharmaceutical industry and preparing dossiers associated with CMC. In this episode, Ed, Brian, Meranda and Catherine discuss breakthrough designations, the role of agencies such as the FDA, and future trends in pharmaceutical regulation.
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TAKEAWAYS:
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03:00 - Dr. Catherine Bernard joins the show to discuss her background in regulatory affairs within the pharmaceutical industry
07:35 - Dr. Catherine speaks to some of the challenges associated with preparing a CMC dossier
10:38 - Dr. Catherine speaks to the vital role project management plays in submissions and explains realistic timelines and target dates
12:58 - Dr. Catherine talks about her experience with breakthrough designations and managing sponsor expectations
20:59 - The importance of listening to regulatory agencies such as the FDA
29:01 - Future trends in pharmaceutical regulation that Dr. Catherine foresees and one thing the audience doesn’t know about Dr. Catherine
32:29 - Ed, Brian and Meranda thank Catherine for joining the show
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ABOUT CMC Live
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FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.
7 авг 2024
