Increasingly, companies across Europe are recognizing the value of implementing Early Access Programmes to provide patients with access to life-changing medicines. However, challenges remain in adhering to a variety of cross-border regulations, clarifying rules around real-world data collection, and accurately anticipating supply volumes. To overcome these hurdles, it is essential for the industry to collaborate and share solutions.

Welcome to the 3rd Operationalise Early Access Programmes Summit Europe, dedicated to fostering open dialogue and sharing experiences in navigating the complex regulatory and operational landscape of Early Access Programmes. This October, join a community of over 140 experts in Access, Clinical Operations, Medical Affairs, and Clinical Supply from leading companies such as Novartis, Biogen, Eli Lilly, Gilead, Incyte, and more. Together, we will elucidate country-specific regulatory pathways in Europe and beyond, bridge the gap between clinical research and commercial supply, and streamline access to life-changing therapies outside the clinical trial setting.



Category: Conferences | Science, Health and Medicine | Pharmaceuticals | Regulatory Affairs

Drug Developer Pricing – Conference + Pre-Conference Workshop Day: GBP 3597.00,
Drug Developer Pricing – Conference Only : GBP 2599.00,
Academic Pricing – Conference + Pre-Conference Workshop Day: GBP 2997.00,
Academic Pricing – Conference Only: GBP 2199.00,
Vendor Pricing – Conference + Pre-Conference Workshop Day: GBP 4297.00,
Vendor Pricing – Conference Only: GBP 3099.00

Speakers: Abdul Kahil, Associate Director – Managed Access Programs, Alexion Pharmaceuticals, Alberto Calabro, Patient Access Program and Supply Lead, Roche, Ann Watkins, Associate Director EUR/ INR Medical Affairs Ops and Planning, Jazz Pharmaceuticals, Benjamin Rotz, Associate Vice President, Global Medical Policy Strategy and Operations, Eli Lilly and Co, Bethany Jordan, Global Medical Affairs Oncology Managed Access Program Lead, GSK, Carole Scrafton, Co-Founder and Chair, Director – Social Medical Coordinator and Website Manager, Patient and Health Advocate, Flutters and Strutters, Carolina Cela, Ramos Medical Affairs Operations Manager, Incyte Corp, Chiara Troncatti, Head, Commercial Operations, EMEA, Amylyx Pharmaceuticals, Dennis Akkaya, Chief Commercial Officer, myTomorrows, Eva Gallagher, Vice President Global Medical Affairs, Agios Pharmaceuticals, Gordon Lundie, Executive Director – Market Access, Gilead Sciences, Helen Dean, Associate Director – Medical Affairs International Operations and Planning, Jazz Pharmaceuticals, Karen Frascello, Senior Director – Medical Affairs, Alnylam Pharmaceuticals, Katja Berg, Innovation Value and Access Strategy, Global Market Access and Pricing, AstraZeneca, Michael Bethel, Global Head of Access Mechanisms, Biogen, Nora Pontynen, Global Capability and Early Access Treatments, Boehringer Ingelheim, Pat Garcia-Gonzalez, Chief Executive Officer, The Max Foundation, Rachel Harrison, Pre-Approval Access Program Lead, Global Medical Affairs, argenx, Ramona Reichenback, Head of Managed Access Centre of Excellence, Novartis, Sara Radenovic, Director – Managed Access Program, GSK, Scott Siegert, Executive Director – Strategy and Operations – Clinical Science and Development, Neurocrine Biosciences, Simone Behre, Lead Medical Advisor EMEA, Amylyx Pharmaceuticals, Vilem Guryca, Expanded Access Programs, BeiGene, Daniel O’Connor, Director – Regulatory Policy and Early Access, Association of the British Pharmaceutical Industry, Jake Popyura, Patient Advocate, Ana Tediosi, Head of Expanded Access Strategy, WEP Clinical, Marjan Sepassi, Vice President – Medical Affairs, Clene Nanomedicine, Rebecca Bibby Group Director of Medicines Access and UK General Manager BAP Pharma