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.
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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.
018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola
CMC Live - Chemistry, Manufacturing & Controls
52 minutes 38 seconds
4 years ago
018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola
In this very special episode of CMC Live, hosts Ed Narke, Brian Lihou and Meranda Parascandola provide an in-depth recap of Season One, complete with direct quotes from all of their illustrious guests. Ed, Brian and Meranda reflect on everything from Jim Mencel’s perspective on expedited drug development programs and Dave Adams’ belief in trusting the API process to Daniel Torok’s analysis of the White Coat Effect and Judy Magruder’s effective strategies for early stage drug development. They share insights from David Blasingame on the advantages and disadvantages of manufacturing in China as well as Hedley Rees’ views on the importance of creating a value chain. Finally, Ed, Brian and Meranda discuss topics they’d like to integrate into Season Two and thank the listeners for their support throughout the year.
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CMC Live - Chemistry, Manufacturing & Controls
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.
