European Platform for Regulatory Science Research meeting

• Date:
  Tuesday, 20 May 2025, 14:00 - 16:30 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

The EMA/HMA European Platform for Regulatory Science Research was launched in March 2025. The Platform brings together academic and not-for-profit researchers and regulators, as well as other stakeholders, with the overall goal to advance research in regulatory science.

During the Platform’s first participant meeting in May 2025, the following topics were discussed:

• introduction to the strategic approach to regulatory science research, the Platform and agenda topics;
• within the broad research need ‘Perform studies to develop optimal PK (and PD) designs in children to support extrapolation from adults’: starting point pharmacological modelling research;
• use of regulatory data in research projects: spotlight on the assessment report.

Registration

The meetings of the Platform are by invitation to Platform participants only. Researchers and regulators who would like to participate in the Platform and its meetings are invited to express their interest by completing the form available via:

• Form for expression of interest

Documents

Agenda - European Platform for Regulatory Science Research meeting

Presentation - Welcome and introduction to the strategic approach to regulatory science research

Presentation - Introduction to the Platform and agenda topics

Presentation - Session 1: Perform studies to develop optimal PK (and PD) designs in children to support extrapolation from adults

Presentation - Session 1: Researcher perspective on state, gaps and opportunities

Presentation - Session 2: Session 2 Use of regulatory data in research projects: spotlight on the assessment report

Presentation - Session 2: EPAR Search for the CONFIRMS Non-Proportional Hazards Research Project

Presentation - Session 2: How can we utilize the large and rich documents that are the EPAR?