Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12

About the Author

Connie Langer
Senior Director, Quality Operations/Environmental Health & Safety
Pfizer
Connie Langer is a Senior Director and leader of the Regulatory Intelligence Team within Pfizer’s Quality Operations and Environmental Health and Safety department. This team...
Michael J. Cohen, PhD
Research Fellow - Global Chemistry, Manufacturing, & Controls
Pfizer Worldwide R&D
Michael Cohen is a Research Fellow in Global Chemistry, Manufacturing and Controls (GCMC) within Pfizer Inc at the Groton, CT site. He received his bachelor’s...
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Lindsey Saunders Gorka
Associate Director in Global CMC
PfiZer
Lindsey Saunders Gorka is an Associate Director in Global CMC at Pfizer, located in Peapack, New Jersey. She supports the development of CMC regulatory strategies...
Megan E. McMahon
Senior Director and Team Leader, Global CMC
Pfizer
Megan E. McMahon is a Senior Director in Global CMC at Pfizer in Connecticut. Megan received her BSc in chemistry from Purdue University and an...
Roger Nosal
Head of Global Regulatory Strategy and Submissions
NGT Biopharma
Roger Nosal is currently Principal Consultant with Roger Nosal PharmaCMC Regulatory Consultants and serves as Head of Regulatory Strategy for NGT BioPharma Consultants, a consortium...
Timothy J.N. Watson, PhD
Vice President – Head of CMC Regulatory Affairs
Gilead Sciences
Dr. Timothy Watson, Ph.D. is Vice President-Head of CMC Regulatory Affairs, Gilead Sciences. Prior to Gilead, Tim lead Pfizer' CMC Advisory Office is a collection...