EFSPI Statistical Leaders Meeting

8th June 2011

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Welcome

• 2nd European Statistical Leaders Meeting

• Thank you to organising team– Chrissie– Stephen– Maylis– Lesley– Ian

• Thank you Amgen– for Hosting the Meeting

• Introductions2

AgendaTime Topic Presenter/Facilitator 9:00- 9:15 EFPSI President Welcome Address

Organisers welcomeFrancois AubinLesley France

9:15-10:45 Model Based Drug Development Stephen Pyke / Ian Hirsch

10:45-11:00 Break

11:10-12:30 Comparative Drug Effects – Network Meta-analyses Maylis Coste / Chrissie Fletcher

12:30-13:30 Lunch break

13:30-13:45 Update from last Meeting• HTA Update• Risk Benefit

Chrissie Fletcher / Lesley France

13:45 – 14:15 Accreditation of Pharmaceutical Statisticians Egbert Biesheuvel

14:15 – 14:30 Update from last Meeting Professional Development for Statisticians

Hans Uli Burger

14:30 – 14:45 Break14:45 – 16:15 Totality of Evidence – Can we make better use of

ResourcesIan Hirsch / Lesley France

16:15 Meeting summary and Actions

16:30 Meeting Close3

What is EFSPI?

• EFSPI = European Federation of Statisticians in the Pharmaceutical Industry

• Founded in 1992 • EFSPI is an “umbrella”, non-profit making

organisation• A federation of National European Groups• Now have 10 national groups• No individual members• Our national organisations collectively represent

2800 members

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EFSPI - Our members

SFdS SSL APF DSBS PSDM

BIAS PSI SBS/BVS BBS FMS

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EFSPI Objectives

• To promote professional standards of statistics and the standing of the statistical profession in the pharmaceutical industry

• To offer a collective expert input on statistical matters to national and international authorities and organisations

• To exchange information on and harmonise attitudes to the practise of statistics in the European Pharma Industry and within member groups

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EFSPI websitewww.efspi.org

Statistical Leaders Meeting

• Develop a forum for Statistical Leaders to– Network and share ideas – Shape and influence our environment

• Education & Continuing Professional Development• Methodology Development & Identification of Best

Practice• Regulatory and Industry policies• Effective working with differing resourcing models

– Help to shape the strategy for EFSPI

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Objectives of this meeting

• To identify up to 3 priority actions for the strategic direction of EFSPI in– Professional Development for Statisticians– Model Based Drug Development

– Comparative Drug Effects – Network Meta-analyses.– Utilising the Totality of Evidence

• Provide feedback from our last meeting• Identify experts who would like to be engaged in

European initiatives

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Format of the meeting

• Each topic will be introduced by a presenter• Facilitated discussion to identify 3 priority

actions• Facilitators will summarise key actions at the

end of each discussion

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End of meeting

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Summary and Close

• Review priorities from each session• Identify experts• Take the recommendations to the next council

meeting• Feedback to participants of this meeting in

Autumn

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