4th Operationalise: Early Access Programs Summit Europe

Welcome to the 4th Operationalise: Early Access Programmes Summit Europe

When patients can't afford to wait, Expanded Access Programmes become a vital lifeline. With growing demand in rare diseases, oncology, and advanced therapies - and increasing expectations from regulators, physicians, and patients - the pressure to execute programmes effectively has never been higher. With 18 of the 27 EU countries having their own compassionate use guidelines, access teams are navigating a complex and high-stakes landscape. Faced with inconsistent regulations, limited internal resources, and heightened scrutiny over compliance, data, and supply, success demands precision, collaboration, and expertise.

Join 120+ leaders from Access, Clinical Operations, Medical Affairs, Regulatory, and Supply Chain at the 4th Operationalise: Early Access Programs Summit Europe, the only forum designed to tackle these realities head-on. Whether you’re navigating access for the first time or scaling a complex, multi-country programme, you’ll leave equipped with practical takeaways, proven frameworks, and peer-led case studies to tackle your biggest executional challenges head-on.

Speakers: Annmarie Galli, Head, Global Medical Affairs Research and Compassionate Use / Managed Access Programs, GSK, Antoine Robert, Post-Trial Access Global Lead, Sanofi, Ben Rotz, Associate Vice President - Global Medical Policy, Strategy, and Operations, Eli Lilly and Co., Cassandra Slader, Global Head of Managed Access Programs, UCB, Catherine Singfield, Senior Director and Head of Medical, Evidence Optimisation and Managed Access Programmes Team, Jazz Pharmaceuticals, Katy Mulleady, Director, Pre-Approval Access Operations, Abbvie, Lisa Seifert, Distribution Expert - IMP Delivery, Boehringer Ingelheim, Maja Gallic, Head of Global Medical Affairs Operations and Excellence, Teva Pharmaceuticals, Martina Vanek, Manager for Special Programs, Boehringer Ingelheim, Nicola Gillott, Global Head of Expanded Access, Chiesi, Nina Heiss, Director Global Regulatory Affairs and Scientific Policy, PhD, Merck, Olga Andreeva, Global Medical Excellence Director, Novo Nordisk, Rachel Harrison, Director, Pre-Approval, Post-Trial Access Programmes, Medical Affairs and Evidence Generation, Argenx, Simon Morgan, Team Lead, Qualified Person, Pfizer, Zoe Zeliku, Associate Director, Clinical Development, Value Evidence, Outcomes and Oncology, GSK, Bethany Bearden, Associate Director, Early Access Programmes Operations, Blueprint Medicines, Chiara Troncatti, Head of Business Operations, EMEA , Avidity Biosciences, Dorian Readnour, Executive Director - global patient access, Sarepta Therapeutics, Kjersten Teeter, Director, Head, Medical Affairs, Blueprint Medicines, Magali Taiel, Chief Medical Officer, GenSight Biologics, Mallory Fredericks, Associate Director - Global Patient Access, SpringWorks Therapeutics, Michela Pantaleoni, Chief Market Access Officer, Napo Therapeutics, Natalia Kashtalian, Medical Excellence Manager, Sobi, Sara Tagliatatela, Senior Director, Global Quality Systems and Compliance, Kedrion Biopharma, Sarah Moore, Associate Director, Medical Affairs, ImmunoGen Switzerland GmbH (now a part of AbbVie), Suzanne Webster, Director - International Patient Services and Global Access Post Clinical Trial, Sarepta Therapeutics, Tamara Popov, Global Medical Lead Nephrology, Vifor Pharma, Chris Hendriksz, Chief Community Impact Officer, A Rare Cause, Harpreet Ram, President, GARDaccess, Tanya Collin-Histed, Chief Executive Officer, International Gaucher Alliance, Dennis Akkaya, Chief Commercial Officer, myTomorrows