Rick Friedman, Deputy Director of the US Food and Drug Administration (US FDA) Office of Manufacturing Quality, opened the 2026 ISPE Aseptic Conference with a frank look at how far pharmaceutical manufacturing has come—and a candid reminder of how much is still at stake.
The rapid evolution of AI is reshaping medicine regulation, shifting the technology from exploratory pilots to becoming a structural capability. A keynote presentation by Hilmar Hamann, PhD, Head of the Information Management Division at the European Medicines Agency (EMA), explored the “shifting frontiers” of the current landscape that will define how AI is developed, governed, and trusted...
At the 2026 ISPE Aseptic Conference, John Arigo, PhD, Division Director of the Division of Pharmaceutical Manufacturing Assessment 2 in the Office of Pharmaceutical Manufacturing Assessment (OPMA) at the US Food and Drug Administration (US FDA),...
The following insights were presented by Ib Alstrup, GxP-IT Medicines Inspector, Danish Medicines Agency, at the 2025 ISPE Pharma 4.0™ Conference on 9 December in Barcelona, Spain, and summarized.
The Medicines and Healthcare products Regulatory Agency (MHRA) is leading a transformative shift in pharmaceutical manufacturing with the introduction of the DM framework.
For decades, pharmaceutical companies have grappled with a frustrating reality: bringing a post-approval change to market globally could take up to seven, or in some cases more, years. That meant patients in some countries had to wait years longer than others to benefit from manufacturing improvements, new production sites, or process enhancements. But a shift is underway in the regulatory...
