Master the complexities of running expanded access programs (EAPs) across multiple jurisdictions. In this webinar, you’ll learn how to navigate compliance, anticipate common challenges, leverage EAPs for real-world data (RWD) collection, and design sustainable EAPs that fit the needs of your patients and organization.
Access the webinar recording to gain actionable insights from proven case studies.
Navigating jurisdictions: Key lessons from expanded access case studies beyond the US
Date: May 23, 2024
What you will learn:
Design a sustainable EAP that aligns with organizational objectives, patient needs, and exit strategies—ensuring a smooth transition post-program.
Recognize the three critical regulatory frameworks essential for EAPs and learn strategies to navigate and comply with these regulations across different jurisdictions.
Develop robust mitigation plans for handling supply chain issues and tackling the specific challenges related to cell and rare disease therapies.
Discover tactics for collecting fit-for-purpose RWD in your EAP program through real-world case study examples.
Anke is an immunologist who earned her PhD at the University of Marburg, Germany. She has held various medical affairs positions in small start-up to mid-size companies, including Miltenyi Biotec, Cell Medica, bluebirdbio, and Atara Bio. Currently, she supports Pierre Fabre as senior consultant with a focus on expanded access programs and real-world evidence. Anke’s career is dedicated to advancing gene and cell therapies to treat infections and cancer.
Karlijn Doorn, PhD
Head of Pharma Partnerships & Customer Success, myTomorrows
Karlijn has 7+ years of expanded access experience as the former Head of Operations at myTomorrows. She is currently responsible for building partnerships with BioPharma companies to facilitate access to pre-approval treatments through clinical trials or expanded access programs incl. RWD collection. Prior to joining myTomorrows, Karlijn obtained her PhD in neurodegenerative diseases and worked as lecturer at the University of Amsterdam.
