An Evaluation of Postapproval CMC Change Timelines

About the Author

Director

Harris Pharma Consultancy

Rob Harris, PhD, is a Director of Harris Pharma Consultancy. Previously, Rob was a Senior Director in Global Regulatory Affairs, Chemistry, Manufacturing, and Controls at...

Meike Vanhooren

Sr. Director Global Mfg Compliance

Pfizer

Meike Vanhooren, PhD, has more than 25 years of experience in the pharmaceutical industry covering regulatory, manufacturing, and quality areas. She is based in Germany...

Kara Follmann, PhD

Executive Director for Anti-Infectives

Pfizer

Kara Follmann, PhD, is the Executive Director for Pfizer’s Anti-Infectives, Hospital, Global Brands and Sterile Injectable CMC portfolio within Pfizer Global Regulatory Sciences and is...

Beth Kendsersky

Consultant

Retired

Beth Kendsersky was a Senior Director in Global Regulatory Affairs, Chemistry, Manufacturing, and Controls at Pfizer; she has retired. Beth led a team and managed...

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...

Melinda Imperati

Associate Director

Pfizer

Melinda Imperati is an Associate Director at Pfizer Global Regulatory Affairs Chemistry Manufacturing & Controls in Peapack, New Jersey. She has 26 years of experience...

S. Connor Dennis, PhD

CMC Regulatory Consultant

Pfizer

S. Connor Dennis, PhD, is a CMC regulatory consultant for Pfizer. He is a research scientist with industry experience in drug product development and global...

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...

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