March 24, 2023
American Sociaty for Testing Materials, ASTM, British Pharmacopoeia, College Cork, Compliance Information, E55, EFPIA, eipg, Graham Cook, guideline, ICH, ICH Q12, MQEG, PIER, Product development, Product Lifecycle Management, Q12, Quality Intelligence, Technical Comittee, webinar
Next EIPG webinar is to be held on Tuesday 18th April 2023 at 17.00 CEST (16.00 BST) in conjunction with PIER and University College Cork. Graham Cook, former Pfizer’s Quality Intelligence and Compliance Information team leader and chair of EFPIA’s Manufacturing and Quality Expert Group (MQEG) will explain the context for the development of the ICH Q12 guideline on Product Lifecycle Management.
The ICH Q12 Product Lifecycle Management guideline reached step 4 in the ICH process in November 2019 – where are we with the adoption of this guideline? This webinar will provide an overview of the content, and discuss the opportunities and implications for implementation of Q12 by industry and regulators.
Graham Cook is a pharmacist with a Ph.D. in pharmaceutics. He was appointed to the British Pharmacopoeia Commission between 2010 and 2021 and chairs the Medicinal Chemicals (MC2) Expert Advisory Group and the Analytical Quality by Design Working Party. Between 2012-2018 he was Chairman of the American Society for Testing Materials (ASTM) International E55 Technical Committee developing pharmaceutical manufacturing standards and continues to serve as a member of the E55 Executive Committee. He was a past chair of Pfizer’s Quality by Design Council and previous roles include Technical Director supporting Wyeth Europa Manufacturing and External Supply, and Director Formulation Development for Wyeth Consumer Healthcare (Richmond, Virginia, USA).
This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.
