Thomas Zimmer, PhD, is the Vice President of European Operations at ISPE. He previously served as Senior Vice President of the Corporate Division for Safety, Quality & Environmental Protection at Boehringer Ingelheim, where he worked from 1981 to 2015. During his tenure, he held various positions in pharmaceutical development, manufacturing, and management operations across the Americas and Europe. He also led the Project Production Alliance Europe and later became Head of Pharma Operations in France.
Thomas chaired the Anti-Counterfeiting Ad Hoc Group for nine years and was a member of the Scientific, Technical, and Regulatory Policy Committee (STPR) at the European Federation of Pharmaceutical Industries Associations (EFPIA). He also chaired the Industry Advisory Board for the Institute for Packaging at the University of Applied Sciences in Berlin. At ISPE, he is a member of the International Leadership Forum (ILF) and serves on the board of the Pharmaceutical Security Institute (PSI), an organisation of major pharmaceutical companies dedicated to combating counterfeit medicines. Additionally, he actively participates in several global ISPE initiatives, including those focused on Drug Shortages.
Thomas is a member of the French Académie Nationale de Pharmacie (ANP) at the University of Paris. He studied pharmacy at Johann Wolfgang Goethe University in Frankfurt/Main, where he completed 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....