Technical workshop on real-world metadata for regulatory purposes

• Date:
  Monday, 12 April 2021
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

Data characterization and discoverability are goals for the scientific community and for medicines regulation. The HMA-EMA joint Big Data Task Force recommended “to promote data discoverability through the identification of metadata” as part of its Priority recommendations of the HMA-EMA joint Big Data Task Force, which is reflected in the Big Data Steering Group work plan.

The objective of this workshop is to review and gather stakeholders’ feedback on:

• preliminary list of metadata required for characterising real-world data sources and definitions to fulfil regulatory use cases;
• proposed options for metadata from real-world data sources collection and maintenance processes;
• proof-of-concept catalogue of data sources and metadata.

Documents

Summary report - Technical workshop on real-world metadata for regulatory purposes

Reference Number: EMA/139729/2021

Agenda - Technical workshop on real-world metadata for regulatory purposes

AdoptedReference Number: EMA/139729/2021

Presentation - Technical workshop on real-world metadata for regulatory purposes - Opening remarks (Nikolai Brun)

Presentation - Overview of the project Metadata for data dIscoverabilityaNdstudy rEplicabilityin obseRVAtionalstudies (MINERVA) (EMA/2017/09/PE/16) (Susana Perez-Gutthann)

Presentation - Overview of the HMA-EMA Big Data Taskforce priority 3: recommendation to enable data discoverability (Stefania Simou)

Presentation - Stakeholders feedback from pre-meeting survey: Session 1 Feedback process overview (Susana Perez-Gutthann)

Presentation - Session 1: Overview of the regulatory use case (Romin Pajouheshnia)

Presentation - Session 1: Overview of the regulatory use case (Romin Pajouheshnia)

Presentation - Session 1: Conceptual framework (Rosa Gini)

Presentation - Session 2: Preliminary list of metadata (Romin Pajouheshnia)

Presentation - Session 2: Stakeholders feedback from pre-meeting survey: metadata (Romin Pajouheshnia)

Presentation - Session 3: FAIR catalogue sustainability (Miriam Sturkenboom)

Presentation - Session 3: Stakeholders feedback from pre-meeting survey: sustainability & collection

Presentation - Session 4: Preliminary proof-of-concept catalogue tool (Morris Swertz)

Presentation - Session 4: Stakeholders feedback from pre-meeting survey: proof-of concept catalogue tool (Morris Swertz)

Multimedia