Taking place Thursday, 1 October, from 15:00 to 16:00 CEST in Room 4, this 60-minute symposium, chaired by Hemme Hijma and Elisabeth Wischnitzki, covers basic principles and current clinical and methodological topics in EU medicines regulation as applied directly to ophthalmology.
If you are developing new therapies, designing clinical trials, or navigating the rapid arrival of artificial intelligence in ophthalmology, Thursday afternoon’s EMA symposium is an essential destination. Grounded by a keynote presentation from Jane Moseley, Senior Scientific Officer at the European Medicines Agency (EMA), the session addresses the pivotal questions facing modern drug and digital tool development: where we want to go with AI in medicines, where regulation stands today, and how developers can actively engage with regulators to get there.
For congress delegates, the session offers a rare and direct bridge between cutting-edge retinal science and the regulatory frameworks that ultimately determine whether new treatments reach patients. As the ophthalmic landscape rapidly expands beyond traditional therapeutics into novel mechanisms, surrogate endpoints, and AI-driven clinical tools, alignment with European regulators has never been more critical. Moseley’s address highlights the EMA’s commitment to a human-centered approach to AI and early engagement, offering practical clarity on how both commercial developers and non-commercial academic sponsors can seek formal regulatory guidance early in the evidence generation process.
Beyond artificial intelligence, the session delves into the exact clinical flashpoints preoccupying retina specialists today. From establishing primary and surrogate endpoints in pivotal trials to digesting key takeaways from the recent European Medicines Regulatory Network workshop on Geographic Atrophy, the speakers provide actionable methodological insights that directly impact trial design and clinical translation. Arriving at a time when regulatory standards are evolving alongside rapid technological shifts, this forum gives EURETINA attendees an unprecedented opportunity to hear straight from active regulators—and to voice their own questions during the closing live Q&A.
