Dr. Randy Perez retired from the position of Director of Information Governance and Management for Novartis Pharmaceuticals in 2015. During his 32-year tenure at Novartis his responsibilities included a wide range of IT Compliance issues, such as GxP, Sarbanes-Oaxley, and data privacy. He served on several global teams dealing with computer systems compliance issues and authored many of the...
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....
This virtual ISPE Global Pharmaceutical Regulatory Summit, held on 28 April 2021, brought together eleven regulators from different parts of the world to discuss how their approach to GMP inspections have adapted to the COVID-19 pandemic. Such a large number of regulators at a single forum is unprecedented for ISPE.
