THINK TANK: Use of Cardiovascular Registry Data in European Regulatory Pathways

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THINK TANK: Use of Cardiovascular Registry Data in European Regulatory Pathways: Part l

Date: September 8th, 2023. Rotterdam, NL

PART I: Conceptualization

Ernest Spitzer (NL) Introduction to EU-MDR Cardiovascular Collaboratory
Jan Tijssen (NL) Use of Informed Consent for Registry Data Collection: Academic vs. Regulatory Research
Eugene McFadden (IE) Are clinical registries the ultimate all-comers design for interventional cardiology trials?
Jose M. de la Torre (ES) Academic Collaborations leading to Clinical Trials and Registries

PART I: Cardiovascular Registries in Europe

Armando Perez de Prado (ES) EPIC: the Spanish Experience
Claude Hanet (BE) The Belgian Experience
David Erlinge (SE) SCAAR: the Swedish Experience (online)
Ingibjörg Jona Gudmundsdottir (IS) The Icelandic Experience (online)
Ernest Spitzer (NL) Cardialysis: the European Perspective.

PART III: Future considerations

Claire Ren (NL) Echocardiography Core Lab operations within Academic vs. Regulatory Research
Claes Held (SE) Role of Endpoint Adjudication within Clinical Trials vs. Registries
Jeroen Bax (NL) Clinical Value of Imaging Databanks: The Leiden Experience

PART IV: Implications

Eric Boersma (NL) Data requirements for reliable and consistent statistical reports and interpretation
Victoria Delgado (ES) Evidence-based medicine: Data Requirements and Role of Clinical Registries

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