Working Groups

EFSPI has 4 permanent working groups:


Regulatory Affairs

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The EFSPI regulatory committee co-ordinates regulatory activities across the European Pharmaceutical Statistical community. The key areas of engagement are the Review of regulatory guidance to provide consolidated cross industry responses and identification regulatory statistical issues that are concern across industry for discussion with regulators.

Chair: Dr. Christoph Gerlinger Bayer Pharma AG
Global Clinical Statistics
13342 Berlin, Germany
Tel: (49) 30 468 11829
Fax: (49)30 468 91829
Email: christoph.gerlinger@bayer.com

 

Scientific Affairs

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EFSPI's Scientific Affairs Committee organises European Scientific Meetings (ESM) and European Scientific Conferences (ESC). The committee aims to organise around three scientific events each year at various European locations. We provide a platform for key opinion leaders from regulatory, academia and industry to speak. Details and slides on past events can be found under EFSPI International Events.

Chair: Egbert Biesheuvel PhD
Uppsalalaan 12, 3584 CT Utrecht
PO Box 80141, 3508 TC Utrecht
The Netherlands

T: +31 30 2095 000
M: +31 646 869 728
E-mail: egbert.biesheuvel@danone.com

 

Communications

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The Communications Officer is responsible for writing and distributing quarterly newsletters, maintaining the EFSPI website, co-ordinating collaborations with other organisations and seeking opportunities to raise the profile of EFSPI.

Chair: Chrissie Fletcher AMGEN LTD
Amgen Offices
1 Uxbridge Business Park
Sanderson Road
Uxbridge
UB8 1DH
Tel: (44) 1223 436264
Email: fletcher@amgen.com

 

Data Transparency

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EFSPI has a data transparency working group led by Uli Burger (Roche, Switzerland) and Sally Hollis (AstraZeneca, UK). The objectives are to:

  • To identify and prospectively prioritize statistical issues in data transparency
  • To co-ordinate statistical contributions across Europe to the data transparency debate
  • To disseminate relevant information on the topic across the statistical community
  • To develop and share a vision of the potential longer term impact of data transparency.

There are 5 work streams: one is focused on providing input into EMA/EFPIA related data transparency activities, a second is developing recommendations for re-analysis practices, a third is assessing the future impact to Biostatistics with increased data transparency, a fourth is establishing what are the minimum requirements for sharing data, and a fifth is how to ensure patient confidentiality. If anyone is interested to learn more about these activities, or contribute, please contact Uli Burger (hans_ulrich.burger@roche.com) or Sally Hollis (Sally.Hollis@astrazeneca.com).

Chair: Uli Burger Roche
Int Global Head Oncology Biostatistics
Biometrics pRED Liaison
Site head biostatistics Basel
CH 4070 Bldg 670 R 5.09
Switzerland
Tel: +41 (0) 61 68 81499
Email: hans_ulrich.burger@roche.com

Chair: Sally Hollis AstraZeneca
Parklands,
Alderley Park
Macclesfield
Cheshire
SK10 4TG
United Kingdom
Email: sally.hollis@astrazeneca.com