For several years, ISPE has steadfastly organized hands-on training sessions to enrich classroom learning. Despite the challenges posed by the pandemic, we have successfully developed a program that integrates practical, experiential learning, leveraging ISPE's comprehensive training materials. We are thrilled to announce our partnership with the European Aseptic and Sterile Environment (EASE)...
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.1
In the beautiful city of Barcelona, Spain, ISPE will host members, vendors, pharmaceutical companies, consulting firms, and design companies for the 2023 ISPE Pharma 4.0™ and Annex 1 Conference on...
The updated EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products released in August 2022 introduced changes which require more stringent sterile manufacturing processes, including implementing a contamination control strategy and new technology to reduce the risk of contamination. Regulators discussed those changes and how they impact manufacturing practices during panel...
A panel of regulators representing BfArm, Germany; the Therapeutic Goods Administration, Australia; and the US FDA took place at the 2021 ISPE Biotechnology Conference and Workshop. 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....
