EUROPEAN MEDICINES AGENCY - Overarching methodologies workshop on 22-23 November 2023

With a view to progress the alignment process and ensure stakeholder needs are recognised and incorporated, an on-site multi-stakeholder Methodology Workshop will be held on 22-23 November 2023. The focus will be on discussing key topics related to Methodology guidance, with the aim to identify guidance needs and to propose scopes.

date: 29/06/2023

A call for participants will be published in August 2023, also providing the opportunity for stakeholders to propose topics for discussion. In addition, participants from the European Medicines Regulatory Network (EMRN) will focus on aligning and consolidating guidance development processes.

ACT EU Priority Action 8 works towards an aligned clinical trial guidance development across the EMRN resulting in high impact guidance documents implemented in practice.