Rob Harris, PhD

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Harris Pharma Consultancy
Director
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 Pfizer Inc. He led a team overseeing manufacturing site changes for Pfizer’s small molecule portfolio, having previously been responsible for the CMC dossiers supporting international submissions for new small molecule drug products. Prior to Pfizer, Rob spent two years at Wyeth Pharmaceuticals, responsible for the CMC dossiers supporting EU submissions for new small molecule products. Rob was Head of Regulatory Affairs in the UK office for Sanofi for nine years; during this time, he chaired the ABPI UK Regulatory Committee for one year. Rob earned his PhD in the pathophysiology of cerebral ischemia from the University of London.

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An Evaluation of Postapproval CMC Change Timelines
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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)...