返回 Agenda
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)
Health Canada Perspective
Stephen Horne, PHD
Health Canada, Canada
Senior Evaluator,Bureau of Pharmaceutical Sciences
FDA Perspective
Hasmukh Patel, PHD
FDA, United States
Director, OLDP, OPQ, CDER
Nitrosamines: What We Have Learned as Industry Professionals for a New Path Forward
Ganapathy Mohan, PHD
Merck & Co., Inc., United States
Head of External Affairs (Quality)