Thomas Zimmer, PhD, is ISPE Vice President, European Operations. He previously was Senior Vice President of the Corporate Division, Safety, Quality & Environmental Protection at Boehringer Ingelheim, where he worked from 1981 to 2000 and held several positions in pharmaceutical development and pharmaceutical manufacturing and in the area of management operations for the Americas and Europe. He was also Head of the Project Production Alli-ance Europe and later Head of Pharma Operations at Boehringer Ingelheim France. Thomas is Chair of the Anti-Counterfeiting Ad Hoc Group and a mem-ber of the Scientific, Technical and Regulatory Policy Committee at the European Federation of Pharmaceutical Industries and Associations. He is Chair of the Industry Advisory Board for the Institute for Packaging of the University of Applied Sciences in Berlin, a member of ISPE’s International Leadership Forum, and a board member of the Pharmaceutical Security Institute. He studied pharmacy at the Johann Wolfgang Goethe University in Frankfurt/Main, where he wrote his doctoral thesis in pharmaceutical technology.
The fifth Pharma 4.0™ conference was held December 2022 in Vienna, Austria, in combination with the Aseptic Processing conference. Nearly 500 participants attended either in person or online to learn about the latest developments.
The upcoming challenges and opportunities of digital transformation were the topic of a panel discussion held on 9 May 2023 at the 2023 ISPE Europe Annual Conference in Amsterdam, The Netherlands.
The ninth ISPE Europe Annual Conference was the first in-person conference after a break of over two years due to the pandemic. For travel-related reasons, some attendees participated remotely. With 450 participants on-site and nearly 490 total attendees, the usual atmosphere of an
Annex 1 of the EC GMP Guide "Manufacture of Sterile Medicinal Products" has a long history. First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015. The first draft for comments from industry stakeholders was...
ISPE’s Pharma 4.0™ initiative provides guidance, aligned with the regulatory requirements specific to the pharmaceutical industry, to accelerate Pharma 4.0™ transformations. Also known as the Smart Factory, the objective of Pharma 4.0 is to enable organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of...
ISPE continues to work with a group of industry associations to assist the European Union (EU) and the European Medicines Agency (EMA) with implementation of revision of Annex 1, Manufacture of Sterile Products....