Chris Potter graduated from the University of Exeter with a degree in chemistry and completed a PhD at Imperial College London University in organic chemistry. He started work at Beecham Research Laboratories, and moved to Sterling-Winthrop to take management positions in both pharmaceutical and analytical development. During this period he worked on both ethical and over-the-counter drug development. For the later period of his career, Potter moved to ICI Pharmaceuticals, later Zeneca, then AstraZeneca where he had a senior position as manager of Analytical Development and R&D QA and CMC Project Management Group with responsibility in both the UK and US. He finished his career as Director of External Pharmaceutical Programmes. Potter retired at the end of October 2007 and is now performing part-time CMC consultancy work. He is currently part time Technical Project Manager for ISPE's PQLI Program. Potter was a member of EFPIA's ad hoc Quality Group from 1996 to 2007, and during this period was EFPIA topic leader for ICHQ6A, Specifications for New Drug Substances and New Drug Products, and ICH Q4B, Regulatory Acceptance of Pharmacopoeial Interchangeability. Potter led EFPIA's PAT Topic Group, which produced a Mock P2 to promote discussion and understanding regarding how ICH topics Q8 and ICH Q9 could be implemented.
At the 2023 ISPE Annual Meeting & Expo held in Las Vegas, NV, USA on 18 October 2023, a panel of global regulators answered questions submitted by attendees. The panel consisted of Paul Gustafson, PIC/S...
Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic. Many regulators have instituted requirements for reporting potential or actual drug shortages.1
1Acosta, A., E. P. Vanegas, J. Ronvira, B. Godman, and T. Bochenek. “Medicine Shortages: Gaps Between Countries and...
ISPE has launched an important new initiative, “Enabling Global Pharma Innovation: Delivering for Patients,” in support of the aspirations of many regulatory agencies globally to promote introduction of innovative pharmaceutical manufacturing.
A one-day seminar titled ICH Q9(R1): The Next Frontier was hosted by the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (TU Dublin) on 1 June 2023. Professor Anne Greene of TU Dublin and Marty Lipa, Merck & Co., co-chaired the seminar....
An informative and lively regulatory panel discussion was held at the 2023 ISPE Europe Annual Conference in Amsterdam, The Netherlands on 9 May 2023. The session included regulators from the European Medicines...
The ISPE Drug Shortages Initiative Team conducted a webinar on 9 February 2023 to discuss regulatory and industry insights on drug shortage prevention with a focus on the Asia-Pacific region. The webinar was moderated by Vivien Santillan, Regional Director, Asia, Novatek International. Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the...