Workshop on the draft guideline on registry-based studies

• Date:
  Lundi, 19 octobre 2020, Journée Entière
• Lieu:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This half-day virtual workshop will give an overview of the draft guideline on registry-based studies. Stakeholders will have the opportunity to discuss questions, perspectives on the usefulness of the document and recent experience on methodological aspects of registry-based studies, such as the use of a large registry for clinical trials.

EMA’s cross-committee task force has developed the draft guideline. It is open for public consultation until 31 December 2020. For more information, see the EMA Patient registries web page.

Documents

Agenda - Workshop on the draft guideline on registry-based studies

Reference Number: EMA/428155/2020

Draft guideline on registry-based studies

Draft: consultation closed Consultation dates: 24/09/2020 to 31/12/2020 Reference Number: EMA/502388/2020

Submission of comments on ‘Guideline on registry-based studies’ (EMA/484811/2020)

Presentation - 1.3 Overview of core recommendations of the draft guideline and comments received (Xavier Kurz, Valerie Strassmann)

Presentation - 2.6 Industry perspective on registry (Chris Chinn)

Presentation - 2.6 Registry holders perspective (Eoin McGrath)

Presentation - 2.6 Patients association perspective (Mariette Driessens)

Presentation - 2.6 Regulators example MS registry (VMarion Haberkamp)

Presentation - 2.6 Stakeholder perspective regulator (Milena Stain)

Presentation - 3.8 Experience of randomisation within a registry (Barbara Casadei)

Presentation - 3.9 Data quality and data verification in registries - results of a stakeholders survey (Carla Jonker)

Presentation - 3.10 Survey on the collection of data on adverse events related to medicinal products through registries (Kelly Plueschke)