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Wednesday, June 30 • 10:00am - 11:00am
#321 SL: Nitrosamines: What We Have Learned as Regulators and Industry Professionals for a New Path Forward

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-612-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Ganapathy Mohan, PhD

Speaker

Health Canada Perspective
Stephen Horne, PhD

FDA Perspective
Hasmukh Patel, PhD

Nitrosamines: What We Have Learned as Industry Professionals for a New Path Forward
Ganapathy Mohan, PhD



Speakers
avatar for Ganapathy Mohan

Ganapathy Mohan

Head of External Affairs (Quality), Merck & Co., Inc., United States
Ganapathy Mohan leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until April 2017, he was the head of Small Molecule Development Quality. Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015. Prior to joining... Read More →
SH

Stephen Horne

Senior Evaluator,Bureau of Pharmaceutical Sciences, Health Canada, Canada
Stephen is a Senior Quality (CMC) Reviewer in the Bureau of Pharmaceutical Sciences, TPD, Health Canada. Stephen earned a Ph.D. in synthetic organic chemistry (Waterloo, ON) and completed post-doctoral research at Stanford University (Palo Alto, CA). He has over 25 years of industrial... Read More →
avatar for Hasmukh Patel

Hasmukh Patel

Director, OLDP, OPQ, CDER, FDA, United States
Dr. Hasmukh Patel is the Division Director in the Division of Post-Marketing Activities 1 (for NDAs) in the Office of Lifecycle Drug Products (OLDP), OPQ, CDER. He is with the FDA for more than 20 years. Pharmaceutical Science (OPS). Dr. Patel has extensive technical, regulatory and... Read More →


Wednesday June 30, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session