The operational expert group is established under the Committee for Medicinal Products for Human Use (CHMP) and the Methodology Working Party (MWP).
Its tasks include writing and maintaining product specific bioequivalence guidelines, clinical pharmacology Q&As and supporting the Committee for Medicinal Products for Huma Use (CHMP), Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) and the Scientific Advice Working Party (SAWP) on questions related to generic products and clinical pharmacology topics.
EMA will provide information on the mandate, responsibilities and procedures of this working party as soon as available.
The operational expert group is composed of European experts that the CHMP nominates. This process takes into consideration the best available expertise needed to deliver on the group’s commitments.
The current members are listed below, in alphabetical order of surname. Their declarations of interest are available in the European expert list.