Methodology European Specialised Expert Community

The Methodology European Specialised Expert Community (Methodology ESEC) is a platform for information-sharing among European experts on scientific and methodological topics relevant to the European medicines regulatory network.

The Methodology ESEC operates under the Methodology Working Party (MWP) and Committee for Medicinal Products for Human Use (CHMP).

Role

This Methodology ESEC provides a platform for:

• contributing to delivering the MWP workplan, including providing expertise for temporary drafting groups and operational expert groups (OEGs);
• interacting with stakeholders;
• knowledge transfer, information sharing and communication, including training in methodological topics.

The group does not initiate any regulatory actions or decisions on product-related activities.

Its work is organised into topic areas to support the identification of experts, communication flows and stakeholder interaction:

• AI and data science
• Biostatistics
• Clinical pharmacology
• Modelling and simulation
• Pharmacogenomics
• Real-world data

New topic areas may be formed based on scientific and regulatory needs.

Mandate, rules of procedure and work plan

Mandate, objectives, and rules of procedure for the European Specialised Expert Community (ESEC) for Methodology

Reference Number: EMA/125839/2023

For details on the work programme for the Methodology ESEC, see Methodology Working Party. 

Composition

The Methodology ESEC consists of European experts nominated according to their specific knowledge and/or strong interest in a particular field. These include statistics, clinical trial methodology, modelling and simulation, real world evidence and artificial intelligence and pharmacogenomics.

EMA's scientific committees and the Scientific Advice Working Party (SAWP) are responsible for nominating the members.

All members have signed a public declaration of interests and confidentiality undertaking form.

Members can join multiple topic areas.

Members

Methodology European Specialised Expert Community (ESEC): Members

Reference Number: EMA/76344/2024 Summary:

List of members in the Methodology European Specialised Expert Community.