Biostatistics Operational Expert Group

The Biostatistics Operational Expert Group (BSOEG) provides regular product-related support to the European Medicines Agency's (EMA) Scientific Advice Working Party on clinical trial methodology and statistical topics.

This operational expert group is established under the Committee for Medicinal Products for Human Use (CHMP) and the Methodology Working Party (MWP).

Its tasks include supporting the Scientific Advice Working Party on questions related to clinical trial methodology and statistical topics.

Mandate and rules of procedure

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

Composition

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 interests are available in the European expert list:

• European experts

Members

• Alexandra Karin
• Andreas Brandt
• Angelika Geroldinger
• Anja Schiel
• Ann-Kristin Leuchs
• Armin Koch
• Aysun Cetinyurek Yavuz
• Bergrún Tinna Magnúsdóttir
• Borja García López-Rey
• Bruno Delafont
• Dana Gabriela Marin
• Elina Asikanius
• Fabrice Eroukhmanoff
• Ferran Torres
• Heidi Mestl
• Joerg Zinserling
• John Aspegren
• Lukas Malte Aguirre Davila
• Norbert Benda
• Steven Teerenstra
• Susanne Urach
• Tommi Nurminen
• Xiaofei Liu