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Real-world evidence

A one-day workshop organised with the contribution of the European Medicines Agency

28/06/2022 09:00 28/06/2022 15:15 Europe/Paris Real-world evidence

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Chairpersons: Prof. Piotr Szymanski (Chairman of the ESC Regulatory Affairs Committee), Prof. Stefan James, Prof. Franz Weidinger (ESC President-elect and ESC Chair of the CRT), Dr. Isabelle Lordereau-RIchard (Amgen), Prof. Anders Himmelmann (AstraZeneca)

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.

Session 1

Session 2

Session 3



09:00 - 09:10

Arrival and welcome coffee

09:10 - 09:15

Welcome – Background and objectives of the workshop


09:15 - 09:35

Introductory talk - Current and future EU Health agenda - main initiatives relevant to real world evidence collection and use.

Dr. Andrzej Rys - DG Sante via ZOOM

09:35 - 09:45

Patient perspective

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.

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.

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.

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.

Andrej Segec - EMA

11:15 - 11:30

EUROHEART as a registry use case.

Prof. Lars Wallentin - ESC

11:30 - 11:40

The role of industry in establishing effective registry network in CVD.

Dr James O’Kelly - Amgen

11:40 - 12:30

Panel discussion

12:30 - 13:30


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.

Prof. Marcello Arca - University Hospital Policlinico Umberto I - Rome

13:40 - 13:50

Post-marketing RWE for DOAC’s

Dr. Jose Chaves - Pfizer

13:50 - 14:05

The role of Electronic Health Records (EHR) in providing and supporting RWE.

Prof. Dipak Kotecha - ESC

14:05 - 14:20

Regulatory perspective on utilizing RWD, gaps to fill and ongoing opportunities.

Kelly Plueschke – EMA via ZOOM

14:20 - 15:00

Panel discussion

15:00 - 15:15

Wrap-up, conclusions, next steps and publication


End of the workshop