The Biostatistics Working Party was set up by the Committee for Medicinal Products for Human Use (CHMP) in order to carry out specific tasks related to the use of biostatistical methods in the assessment of medicines.
The Working Party's work includes:
- preparing, reviewing and updating of guidelines and concept papers;
- contributing to Scientific Advice Working Party activities upon request;
- contributing to product-related assessment following specific CHMP requests;
- preparing specific position papers and question-and-answer documents following specific CHMP requests;
- interacting with stakeholders under the supervision of the CHMP;
- European and international co-operation under the supervision of the CHMP;
- contributing to other committees' needs;
- training assessors.
Mandate, rules of procedure and work programme
More information on the Working Party's responsibilities and composition is available in these documents:
- Mandate, objectives and rules of procedure for the temporary working parties and drafting groups
- Work plan
The Working Party is composed of European experts selected from or associated with the national agencies with specific expertise in biostatistics. Nominations for members are adopted by the CHMP.
Additional experts may also be invited to participate in the work of the Working Party for particular topics for which specific expertise is required.
Below (in alphabetical order of surname) are the current members of the Biostatistics Working Party. The members' declarations of interests are available in the European expert list.
- Norbert Benda
- David Brown
- Christian Gartner
- Robert James Hemmings
- Armin Koch
- Thomas Lang (Vice-Chair)
- Steven Teerenstra
- Ferran Torres
- Joerg Zinserling