ISPE Appoints John Berridge, PhD, as European Regulatory Affairs Advisor

01-16-2008: ISPE, a global not-for-profit association of 25,000 pharmaceutical professionals, has appointed John Berridge, PhD, as Europe Regulatory Affairs Advisor. He will take the post 1 February 2008. In this position Berridge will assist ISPE in its interactions with European regulatory authorities as well as helping to move forward ISPE's new Product Quality Lifecycle Implementation (PQLI) initiative.

Berridge retired from Pfizer Global Research and Development at Sandwich, England at the end of January 2006 as European Vice President of Pharmaceutical Sciences. Since then he has been a consultant and advisor to a portfolio of international clients, and a leader and visionary in ISPE's Product Quality Lifecycle Implementation (PQLI) initiative, which was launched in 2007. PQLI brings together industry and regulators in the United States, Europe, and Asia-Pacific to help industry find solutions to the challenges in implementing ICH guidances.

Berridge spent more than 31 years at Pfizer, starting as an analytical chemist, and more recently responsible for all aspects of chemistry, pharmacy, analytical, and regulatory CMC in Europe. His research interests have been directed toward high-performance liquid chromatography, with special emphasis on the use of chemometrics to aid method development. More than 40 papers and a book have been published and this research has been recognized by the award of the Chromatographic Society's Jubilee medal in 1989.

Berridge was involved in the ICH processes from their inception, representing EFPIA in the quality topics discussions. He has contributed to guidelines on impurities in drug substances and their dosage forms, specifications, was the industry rapporteur for the Common Technical Document (Quality) and was the rapporteur for the Pharmaceutical Development Guideline (Q8 and its addendum which reached Step 2 in November of this year). At FIP's 55th World Congress in Stockholm in 1995 he was presented with an IPS award for his outstanding contribution to industrial pharmacy, and in September 1997 he was awarded the Royal Pharmaceutical Society Chiroscience award for his services to the pharmaceutical industry and for his work within ICH.