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. She is a member of the Scottish Health Technologies Group Council (HTA appraisal committee).
Moving beyond isolated advocacy to accelerate diagnosis, this workshop will holistically explore how early diagnosis fits within the rare disease ecosystem from development of diagnostic technologies, to care pathways and policy frameworks. It will be based on a three-part discussion to:
- Move beyond purely technical debates
- Elicit a range of opinions and different practices
- Align with European policy developments in rare diseases.
- How can joint clinical assessments reshape patient access across Europe?
- How can joint scientific consultations influence global evidence strategies?
- Strategic implications of EUHTA for global clinical development
- Lessons for orphan medical products (OMPs), practical implications and decision-maker learnings
- The IHI RealiseD project – Improving evidence generation
- The HTAi Rare Disease Interest Group – Improving evidence assessment