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, pharmacokinetics, pharmacogenomics, 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

The three-year work plan is available below:

Revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Consultation dates: 01/11/2023 to 30/11/2023Draft: consultation closedReference Number: EMA/CHMP/478317/2023Summary:

The Methodology Working Party workplan constitutes the roadmap of MWP activities on the basis of evolving identified priorities. The updated workplan has been adopted by EMA’s human medicines committee (CHMP) and is now open for public consultation.

All key stakeholders are therefore encouraged to provide their feedback through the EU survey by 30 November 2023.

If you respond on behalf of a company that is affiliated with an EU (trade) industry organisations, you are encouraged to share your comments to the respective affiliated EU (Trade) Industry organisation.

EMA will provide information on the mandate, responsibilities and procedures of this working party as soon as available.

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