About this SESSION
This session of the Clinigen Virtual Insights Week will explore the role of data from early access programs in supporting Health Technology Assessment (HTA) submissions. Key discussions will include aligning the data that HTA bodies consider, specific situations where early access data can be leveraged, and the strategic use of this data to address uncertainties. The session will provide valuable insights into how early access programs can inform clinical trial design, demonstrate patient needs, and ultimately substantiate a product's value proposition.
What we'll cover
- Aligning data from early access programs with HTA requirements.
- Specific scenarios where early access data can effectively support HTA submissions.
- The relevance of early access data in EU HTA submissions, including Joint Clinical Assessments (JCA).
- Strategies for managing data uncertainty and maximising the value of early access data, particularly in rare diseases.
Meet the speakers
Susanne Michel
- Former Department of Health England/Department of Health in Berlin
- Former Head of PWC European Health Research Center
- Physician in traumatology
Prof Marc Bardou
- Former member of the Commission de Transparence
- Former President of the Commission to evaluate ATU at ANSM
- Physician in gastroenterology
Who should attend
- Professionals involved in Health Technology Assessment.
- Individuals working in regulatory affairs and market access.
- Pharmaceutical industry stakeholders interested in optimising early access programs.
- Clinicians and researchers focused on rare diseases and innovative treatments.
Register to attend
Join us live or watch on demand after the event.
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