Meike Vanhooren

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Pfizer
Sr. Director Global Mfg Compliance
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 and has global responsibility for CMC. Her portfolio at Pfizer touches the complete product life cycle, from investigational new drug applications and investigational medicinal product dossiers for first-in-human clinical studies and new drug applications and MAAs through postapproval life cycle maintenance. Meike has extensive experience in drug development of accelerated programs as well as programs with novel technologies such as continuous manufacturing processes, including successful NDA/MAA approvals. She has been responsible for executing CMC strategies for manufacturing site changes and successfully completed more than 900 transfers impacting more than 22,000 licenses globally. Meike is engaged in discussions on ICH Q12 Lifecycle Management and ICH Q13 Continuous Manufacturing. She earned her PhD in organic synthesis of carbohydrate structures at the University of Hamburg, Germany.

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An Evaluation of Postapproval CMC Change Timelines
Features
An Evaluation of Postapproval CMC Change Timelines

As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. As a result, Boards of Health (BoHs) are challenged with approving these applications in an accelerated timeframe and accommodating the submission of postapproval chemistry, manufacturing, and controls (CMC)...