Methodology Working Party

The Methodology Working Party (MWP) was established by the Committee for Medicinal Products for Human Use (CHMP) in order to pool and use expertise in key areas such as biostatistics, modelling and simulation, clinical pharmacology and pharmacokinetics, pharmacogenomics and diagnostics, artificial intelligence and data science, and real-world evidence.

The MWP's tasks include:

• providing product-related support when requested by EMA Committees and the Scientific Advice Working Party; 
• engaging with stakeholders including international regulators, associations of pharmaceutical companies, and patient and healthcare professional organisations;
• preparing, reviewing and updating guidelines and concept papers;
• providing training and workshops to assessors.

Mandate, rules of procedure and work programme

Mandate, objectives, and rules of procedure for working parties under the quality, non-clinical, methodology, clinical and veterinary domains

Reference Number: EMA/299541/2025

Consolidated 3-year rolling work plan for the Methodology Working Party 2025-2027

Adopted Reference Number: EMA/324489/2024

Composition

The MWP is composed of European experts nominated by CHMP members taking into consideration the best available expertise needed to deliver its commitments.

The current members are listed below, in alphabetical order of surname.

Their declarations of interests are available in the European expert list:

• European experts