Real-world evidence

Objectives of the workshop

• Develop a common ground of knowledge between ESC, EMA and Industry on CV RWE potential value and current limitations and set a common vision for the future.
• Share with EMA CV RWE activities conducted by ESC as well as Industry across various geographies/databases and for various purposes.
• Discuss the current challenges and opportunities when it goes to generate RWE of robust scientific value.
• Understand EMA perspective on CV RWE potential value to enable registration as well as update label.

Programme

• 09:00-09:10 - Arrival and welcome coffee
• 09:10-09:15 - Welcome – Background and objectives of the workshop by Chairpersons
• 09:15-09:35 - Introductory talk: Current and future EU Health agenda – main initiatives relevant to real world evidence collection and use by Dr. Andrzej Rys (DG Sante, via Zoom)
• 09:35-09:45 - Patient perspective by Mr. Rogier Veltrop (ESC Patient Forum member)
• 09:45-11:00 - Session I: Impact of registry-based studies on drug development and clinical practice
  • 09:45-10:00 - How RWD impact drug development – description of how registries impact by Dr. Charles Lee (AstraZeneca)
  • 10:00-10:15 - Current and planned use of RWD in regulatory approval processes – examples from other specialties and learnings for the CVDs field by Dr. Carla Jonker (EMA)
  • 10:15-10:30 - How RWD can impact on guidelines and clinical practice – how RWD made a difference in patient management by Prof. Stefan James (ESC)
  • 10:30-11:00 - Panel discussion
• 11:00-12:30 - Session II: Examples of real world evidence generation across Europe
  • 11:00-11:15 - Data analysis and Real World Interrogation Network (DARWIN EU) – current status and future perspectives by Andrej Segec (EMA)
  • 11:15-11:30 - EUROHEART as a registry use case by Prof. Lars Wallentin (ESC)
  • 11:30-11:40 - The role of industry in establishing effective registry network in CVD by Dr. James O’Kelly (Amgen)
  • 11:40-12:30 - Panel discussion
• 12:30-13:30 - Lunch
• 13:30-15:15 - Session III: How to improve the quality of RWE/registry derived data
  • 13:30-13:40 - Database for monitoring lipid-lowering therapy: a research experience with the web-based national PCSK9i registry of AIFA by Prof. Marcello Arca (University Hospital Policlinico Umberto I, Rome)
  • 13:40-13:50 - Post-marketing RWE for DOAC’s by Dr. Jose Chaves (Pfizer)
  • 13:50-14:05 - The role of Electronic Health Records (EHR) in providing and supporting RWE by Prof. Dipak Kotecha (ESC)
  • 14:05-14:20 - Regulatory perspective on utilizing RWD, gaps to fill and ongoing opportunities by Kelly Plueschke (EMA, via Zoom)
  • 14:20-15:00 - Panel discussion
  • 15:00-15:15 - Wrap-up, conclusions, next steps and publication
• 15:15 - End of the workshop