Mr. Mark Birse

Parexel
Vice President Technical
Mark is a strategically orientated regulatory compliance professional, with a career spanning the regulation of pharmaceuticals and medical devices. Mark has a passion for ensuring patient safety through delivering pragmatic, risk proportionate and innovative approaches to regulation, with a demonstrated success in building and leading high performing teams responsible for multimillion- pound income. Prior to joining Parexel, Mark previously worked at the MHRA where held a number of leadership roles, including Deputy Director Inspection, Enforcement & Standards Division and Head of MHRA Inspectorate and Process Licensing Group, a team with over 75 GXP inspectors. In these roles, Mark worked extensively with international regulators including FDA, EMA and TGA developing compliance and risk-based inspection methodologies with a focus on inspection collaboration and reliance. He was an Executive Bureau member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and also assessed the capability and performance of regulators and provided international training for both regulators and industry. Mark also held leadership roles in the MHRA Medical Device Division with responsibilities for Devices Safety and Surveillance & Software and Apps. Mark’s background is in GMP having initially joined the MHRA in 2002 as a GMP Inspector where he performed inspections globally. Prior to joining MHRA he spent 10 years in Industry with responsibilities for technology transfer and supplier auditing.

Mark is a chemist, a Fellow of the Royal Society of Chemistry and he holds Chartered Chemist and Chartered Scientist status. Mark has been an eligible Qualified Person since 2003 and is an IRCA Principal Auditor under the PQMS-GMP scheme. He also completed an MBA in 2020.

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Regulatory Panel Discussions: Annex 1 Implementation from the Regulators’ Point of View
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Regulatory Panel Discussions: Annex 1 Implementation from the Regulators’ Point of View

The updated EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products released in August 2022 introduced changes which require more stringent sterile manufacturing processes, including implementing a contamination control strategy and new technology to reduce the risk of contamination. Regulators discussed those changes and how they impact manufacturing practices during panel...