About Event
The Operationalise: Early Access Programmes Summit Europe remains the premier European forum dedicated to defining global regulations and sharing real-world case studies for Early Access Programmes. From exploring the potential of harmonized regulatory frameworks to delving into best practices for establishing robust forecasting models for proactive supply planning, and identifying the types of data that are optimal for research and compliance, this summit is essential for those looking to revolutionize their Early Access Programmes.
Featuring in-depth industry discussions and actionable case studies, the 2024 event offered a unique exploration of the most pressing topics and industry bottlenecks. Those who joined the summit were able to:
Engage in the "Guiding Principles for Launching Effective Early Access Programs" and "Advanced Strategies for Optimizing Established Programs" workshop day, providing valuable insights for EAP experts of all experience levels, hosted by Jazz Pharmaceuticals, Neurocrine Biosciences, The Max Foundation, Incyte, Boehringer Ingelheim, Biogen, Agios Pharmaceuticals, and Novartis.
Learn how organizations handle named-patient requests efficiently, review the diverse formats companies use for EAPs across different indications, and explore strategies for balancing affordable patient access with successful commercial availability and reimbursement, featuring insights from GSK, Roche, and AstraZeneca.
Explore the regulatory and practical aspects of providing access to LATAM, Africa, and other regions without commercial launch plans through case studies on Humanitarian Donation Programs and Free-of-Charge Donations, with expert insights from The Max Foundation, Incyte, GSK, and AstraZeneca.
Participate in dedicated networking sessions designed to facilitate rapid yet meaningful connections, all focused on accelerating the availability of life-changing therapeutics to patients.
Who Attends?
Heads of Managed / Early / Expanded / Pre-Approval Access, Named Patient, Compassionate Use, Medical Affairs, Medical Operations, Clinical Operations and Supply from large pharma, biotechs and patient advocates will be in the same room to discuss actionable methods to better operationalise access programmes.
What Your Peers Have to Say:
“It is a non-competitive intelligence forum between key stakeholders that share the common hope and dedicate their engagement to bring new treatment options and innovations for patients” -
“Anne Raimond, Global Evidence Generation Director Medical Affairs Oncology, Servier
“A great exchange from pharma, regulatory, patient organization and patient representatives stakeholders”
“Philipp Schlatter, Patient Access & Drug Supply, Community of Practice Leader, Roche
““There were presentations on a wide range of interesting topics. I also really enjoyed learning from other Pharma companies' experiences”
Monique Smith Senior Manager, Medical Affairs Research, Vertex Pharmaceuticals