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.
ISPE’s Q12 Implementation Team continued its series of training events with a well-attended course for Singapore’s Health Sciences Authority (HSA) in November.
ISPE’s Q12 Implementation team, a working group under the auspices of ISPE's Product Quality Lifecycle Implementation (PQLI)® committee, continued their series of training events with a well-attended course delivered to Singapore’s Health Sciences Authority (HSA) in November 2024.
At the 2024 ISPE Annual Meeting & Expo held in Orlando, Florida, USA, in October, a panel of global regulators and industry professionals addressed harmonization and regulatory convergence, digitalization, particularly the use of artificial intelligence (AI), and supply chain resilience.
In 2023, ISPE launched an expansive and significant initiative, Enabling Global Pharmaceutical Innovation: Delivering for Patients, to address the barriers to technological innovation in the pharmaceutical industry. The first activity of the initiative was to conduct a three-part survey of ISPE members to understand the circumstances and confirm the sources that create barriers to...
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.Acosta, A., E. P. Vanegas, J. Ronvira, B. Godman, and T. Bochenek. “Medicine Shortages: Gaps Between Countries and...