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 of regulatory statistical issues that are concern across industry for discussion with regulators.
Chair: Dr. Christoph Gerlinger Bayer Pharma AG
Email: christoph.gerlinger@bayer.com
Scientific Affairs
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The 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. click here to view
Chair: Egbert Biesheuvel PhD
E-mail: egbert.biesheuvel@danone.com
Communications
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The Communications Officer is responsible for writing and distributing monthly newsletters, updating the EFSPI website, co-ordinating collaborations with other organisations and seeking opportunities to raise the profile of EFSPI.
Chair: Chrissie Fletcher AMGEN LTD
Email: fletcher@amgen.com
Data Transparency
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EFSPI has a data transparency working group led by Rebecca Sudlow (Roche). The objectives are:
- 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 Rebecca Sudlow
Chair: Rebecca Sudlow (Roche)
Email: rebecca.sudlow@roche.com