The Cancer Drug Development Forum (CDDF) will hold a live webinar on “Compassionate Use and EAP for Cancer Drugs – From Fragmentation to a Common Framework in Europe under the New Legislation” on 26 October at 16:00 CET. This webinar will include a 15-minute lecture by François Houÿez (Eurordis) followed by a 15-minute lecture by Ramona Reichenbach (Novartis), closed with a 25-minute panel discussion moderated by Ruth Plummer (CDDF) and Nina Heiss (Merck).
WEBINAR OUTLINE
Compassionate Use (CU) provides early access to unauthorized medicines for seriously ill patients who cannot join clinical trials. European CU access is fragmented because cohort programmes and individual patient requests follow different legislative frameworks, creating country-level inequalities and delays for patients. Key gaps include limited visibility of CU opportunities for patients and physicians, and there is no systematic collection of real-world data leading to missed opportunities.
The new EU pharmaceutical legislation, which comes into force in 2028, has introduced potentially significant changes into the Regulation. These changes could enable a more common approach across Member States, facilitate greater visibility and transparency, and introduce the possibility to make better use of real-world evidence.
The webinar will discuss the challenges and opportunities from a patient and industry perspective.
LEARNING EXPECTATIONS
- Understand the complexities and challenges of operationalizing a CU request that lie in the nature of the current legislation that leads to fragmentation at the country-level
- Understand the need for a common approach and what needs to change
- Learn about the opportunities that aligned implementation of the new legislation could bring
Agenda: (CET time zone)
16:00 – 16:05 Introduction – Ruth Plummer (CDDF) & Nina Heiss (Merck)
16:05 – 16:20 Lecture by François Houÿez (Eurordis)
16:20 – 16:35 Lecture by Ramona Reichenbach (Novartis)
16:35 – 17:00 Panel discussion – moderated by Ruth Plummer (CDDF) & Nina Heiss (Merck)
Ramona Reichenbach
Ramona Reichenbach is Head of Managed Access Center of Excellence and Medical Policy at Novartis, working in the enterprise-wide Chief Medical Office. She leads global efforts to advance standards, governance, and operational excellence across medical and patient-focused programs. With more than 20 years of experience spanning various roles in Drug Development, Medical Affairs and Technical Operations she has played a pivotal role in designing and implementing global frameworks for Managed Access Programs (MAPs), Post-Study Drug Supply (PSDS), and other areas. Throughout her career, Ramona has led major transformation and remediation projects, established frameworks and standards, and driven cross-functional collaboration to ensure patient rights, quality, compliance, and integrity are upheld worldwide. She is recognised for her expertise in managed access and is an active contributor to industry dialogue, conferences and more.
François Houÿez
François has been advocating for patients’ rights since 1989, first joining the HIV/AIDS advocacy movement, and rare diseases in 2003. He now is director of Treatment Information and Access at Eurordis, which he represents at the European Medicines Agency, and at the HTA stakeholder Network. His role is to ensure patient involvement in all decisions that can affect their lives, with equal credibility as other experts.