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DIA 2021 Global Annual Meeting


Nitrosamines: What We Have Learned as Regulators and Industry Professionals for a New Path Forward

Session Chair(s)

Ganapathy  Mohan, PhD

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

Health Canada Perspective

Stephen Horne, PhD

  • Senior Evaluator,Bureau of Pharmaceutical Sciences
  • Health Canada, Canada
Hasmukh  Patel, PhD

FDA Perspective

Hasmukh Patel, PhD

  • Director, OLDP, OPQ, CDER
  • FDA, United States
Ganapathy  Mohan, PhD

Nitrosamines: What We Have Learned as Industry Professionals for a New Path Forward

Ganapathy Mohan, PhD

  • Head of External Affairs (Quality)
  • Merck & Co., Inc., United States