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Nitrosamines: What We Have Learned as Regulators and Industry Professionals for a New Path Forward
Session Chair(s)
Ganapathy Mohan, PHD
Head of External Affairs (Quality), Merck & Co., Inc., United States
This session will discuss challenges from technical, regulatory, and logistics perspectives, impact on the supply chain through this journey and how we avoid future topics by leveraging the lessons learned to device a path forward for such global issues.
Learning Objective : Describe the current status of how nitrosamines are tested along with the technical challenges, regulatory challenges, and supply chain impact; Identify how to collaboratively handle a global issue like this in the future.
Speaker(s)
Stephen Horne, PHD
Senior Evaluator,Bureau of Pharmaceutical Sciences, Health Canada, Canada
Health Canada Perspective
Hasmukh Patel, PHD
Director, OLDP, OPQ, CDER, FDA, United States
FDA Perspective
Ganapathy Mohan, PHD
Head of External Affairs (Quality), Merck & Co., Inc., United States
Nitrosamines: What We Have Learned as Industry Professionals for a New Path Forward
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