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)
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09:00 - 09:10 |
Arrival and welcome coffee |
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09:10 - 09:15 |
Welcome – Background and objectives of the workshop |
Chairpersons |
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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 |
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09:35 - 09:45 |
Patient perspective |
Mr. Rogier Veltrop - ESC Patient Forum member |
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09:45 - 11:00 – Session I - Impact of registry-based studies on drug development and clinical practice |
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09:45 - 10:00 |
How RWD impact drug development - description of how registries impact. |
Dr. Charles Lee - AstraZeneca |
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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 |
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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 |
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10:30 - 11:00 |
Panel discussion |
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11:00 - 12:30 – Session II - Examples of real world evidence generation across Europe |
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11:00 - 11:15 |
Data analysis and Real World Interrogation Network (DARWIN EU) - current status and future perspectives. |
Andrej Segec - EMA |
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11:15 - 11:30 |
EUROHEART as a registry use case. |
Prof. Lars Wallentin - ESC |
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11:30 - 11:40 |
The role of industry in establishing effective registry network in CVD. |
Dr James O’Kelly - Amgen |
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11:40 - 12:30 |
Panel discussion |
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12:30 - 13:30 |
Lunch |
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13:30 - 15:15 – Session III - How to improve the quality of RWE/registry derived data |
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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 |
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13:40 - 13:50 |
Post-marketing RWE for DOAC’s |
Dr. Jose Chaves - Pfizer |
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13:50 - 14:05 |
The role of Electronic Health Records (EHR) in providing and supporting RWE. |
Prof. Dipak Kotecha - ESC |
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14:05 - 14:20 |
Regulatory perspective on utilizing RWD, gaps to fill and ongoing opportunities. |
Kelly Plueschke – EMA via ZOOM |
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14:20 - 15:00 |
Panel discussion |
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15:00 - 15:15 |
Wrap-up, conclusions, next steps and publication |
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15:15 |
End of the workshop |
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Our mission: To reduce the burden of cardiovascular disease.