The European Medicines Agency (EMA) has scheduled a one-day expert workshop on 30 June 2026 to discuss regulatory pathways for adaptive and probabilistic AI models in Good Manufacturing Practice (GMP), according to a draft agenda published on 23 June 2026. The virtual meeting, chaired by EMA's Roberto Conocchia, will bring together regulators and industry representatives to address six topics including strategic risk and compliance limits, human oversight, technical reliability, validation lifecycle management, and cybersecurity for outsourced activities.
The workshop, running from 09:00 to 18:00 CET, opens with welcomes from EMA officials Brendan Cuddy (Chair of GMDP IWG) and Marcel Hoefnagel (Chair of QIG), along with rapporteur Ib Alstrub from the Danish Medicines Agency. Industry opening comments are delivered by Lori Otto of EFPIA. Each topic is followed by a Q&A session, with industry presenters from EFPIA, PDA, and ISPE covering specific areas: Michael Schousboe on AI models, Volkan Kocak on risk limits, Andrea Kurz on human oversight, Toni Manzano on technical reliability and cybersecurity, and Martin Heitmann on validation. The agenda includes coffee and lunch breaks, with closing remarks from the chair and industry representatives Gert Thurau and Linda Wilding.
No prior coverage of this workshop exists in the last 180 days. The meeting is part of EMA's ongoing work to update Annex 22 of the EU GMP guidelines, which covers the use of computerized systems and is expected to incorporate AI-related provisions. Stakeholders impacted include pharmaceutical manufacturers who will need to adapt to new AI validation and oversight requirements, EMA and national competent authorities responsible for enforcement, industry associations like EFPIA and PDA representing developers of AI-based manufacturing tools, and contract manufacturing organizations facing cybersecurity obligations for outsourced activities. The workshop's outcomes may influence future regulatory guidance on AI in pharmaceutical production, balancing innovation with patient safety and data integrity.