At the 2024 ISPE Europe Annual Conference, held in Lisbon, Portugal, 16-18 April, Richard L. Friedman, MS, Deputy Director of the US Food and Drug Administration’s (US FDA) Office of Manufacturing Quality, in...
Insight from Austria’s Regulatory Authority Representative
At the 2024 ISPE Aseptic Conference, held March 12-13 in Vienna, Austria, Christina Meissner, a European Union Good Manufacturing Practice (GMP) inspector at the Austrian Agency for Health and Food Safety since 2013, and Chair of the PIC/S Drafting Group on Annex 2A and 2B, published in May 2021, offered a presentation titled...
On 17 April 2024 at the 2024 ISPE Europe Annual Conference in Lisbon, Portugal, a panel discussion titled “Harmonization to Break Down Barriers to Robust Supply Chains” featured an international panel of experts who discussed drug recalls, drug shortages, risks that can lead to poor drug product quality, quality risk management, Annex 1 implementation and its effect on the supply chain,...
In a prerecorded interview shown during a keynote session at the 2023 ISPE Annual Meeting & Expo, Tom Hartman, ISPE President and CEO, and Dr. Robert M. Califf discussed several far-ranging and important topics. Califf, the US Food and Drug Administration (FDA) 25th Commissioner is a recognized expert in cardiovascular medicine, health outcomes research,...
A fireside chat featuring Robert M. Califf, MD, FDA’s 25th Commissioner of Food and Drugs, and Thomas B. Hartman, President and CEO of ISPE kicked off the 2023 ISPE Annual Meeting & Expo. The following is a brief summary of the session. Look for complete coverage of the interview in an upcoming issue of Pharmaceutical Engineering® magazine.
Annex 1, the European Union’s revised GMP requirements for the manufacturing of sterile medicinal products, will take effect on 25 August 2023. In this panel, experts involved in industry’s commenting of the draft versions of Annex 1 offered background information on how the document was developed and answered questions on its implementation.
