Need To Improve Your Change Management? Regulators Can Help With That

25 January, 2024
Benjamin Stevens
Director of CMC Policy & Advocacy

In an interview with Bioprocess Online, Ben Stevens, Director of CMC Policy and Advocacy at GSK and member of the International Society for Pharmaceutical Engineering (ISPE), provides guidance and insights on the state of change management protocols, what strategies are available to minimize bottlenecks, and how enhanced protocols may be forthcoming in the future. These insights are important to consider, as organizations strive to keep increasingly complex products and processes in compliance with global regulatory authorities.

Ben is part of the ISPE working group focused on ICH Q12. The ISPE ICH Q12 working group, which has been active since 2019, is aimed at helping sponsors navigate their first post-approval change management protocols (PACMPs). Its mission is to support and facilitate adoption of ICH Q12 by regulatory agencies as well as the industry’s implementation of ICH Q12 principles. Ben had previously worked for the US Food and Drug Administration (US FDA) where he reviewed comparability protocols, the US FDA equivalent of PACMPs.

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About Bioprocess Online

Bioprocess Online is part of the Life Science Connect media group. The publication provides technical information, industry knowledge, and content for the biotherapeutic community. Audiences include bioprocess engineers, scientists, bioprocessing managers, biotechnology producers, consultants, QA/QC, project managers, directors, purchasers, marketers, and those involved in biopharm supply chain or facilities management.