Karen Facey | Senior HTA Advisor
University of Edinburgh

Karen Facey worked as a senior statistician in Pharma and medicines regulation before moving to Scotland in 2000 to setup their first national HTA agency. Since 2003 she has been an independent consultant working with all stakeholders on matters relating to HTA in Europe and Canada, with special interests in patient involvement, real-world evidence and rare diseases. Karen has been involved in a range of multi-stakeholder EU-funded proejcts relating to development of HTA with positions at the Universities of Edinburgh, Utrecht and Oxford. She is lead editor on the book on Patient Involvement in HTA and is senior advisor to the RWE4Decisions learning network.

Appearances:

Day 1 (2nd March) @ 09:40

Keynote panel: The future of European JCA: From Assessments to National implementation

Focus: HTA alignment, pricing and reimbursement impact, regulatory mechanics, and what "market readiness" really means under the EU HTA Regulation.

What do the first assessments reveal about evidence requirements, timelines, and the operational bottlenecks HTA bodies are facing on the ground?
How are unified European clinical assessments translating into pricing, reimbursement, and economic decision-making at Member State level?
Where can - and can't - Member States realistically align their processes? What national differences are proving durable, and why?
Building a predictable pathway - What changes to the JCA framework would give developers greater certainty, while still accelerating equitable patient access across Europe?

Anne Willemsen, Chair JCA Subgroup, Zorginstituut Nederland

Fabienne Bartoli, Inspector General, French National Authority for Health

Thomas Müller, Head Of Directorate General 1 - Drugs, Medical Devices, Biotechnology, Federal Ministry of Health Germany

Antonella Cardone, CEO, Cancer Patients Europe

Rimma Berenstein, Deputy Head, Pharmaceuticals Department, G-BA

Moderator: Karen Facey, Senior HTA Advisor, University of Edinburgh