1. EFSPI Statistical Leaders Meeting 8 th June 2011 1

2. Welcome 2nd European Statistical Leaders Meeting Thank you to organising team –Chrissie –Stephen –Maylis –Lesley –Ian Thank you Amgen –for Hosting the Meeting Introductions 2

3. Agenda TimeTopicPresenter/Facilitator 9:00- 9:15EFPSI President Welcome Address Organisers welcome Francois Aubin Lesley France 9:15-10:45Model Based Drug DevelopmentStephen Pyke / Ian Hirsch 10:45-11:00Break 11:10-12:30Comparative Drug Effects – Network Meta-analysesMaylis Coste / Chrissie Fletcher 12:30-13:30Lunch break 13:30-13:45Update from last Meeting HTA Update Risk Benefit Chrissie Fletcher / Lesley France 13:45 – 14:15Accreditation of Pharmaceutical StatisticiansEgbert Biesheuvel 14:15 – 14:30Update from last Meeting Professional Development for Statisticians Hans Uli Burger 14:30 – 14:45Break 14:45 – 16:15Totality of Evidence – Can we make better use of Resources Ian Hirsch / Lesley France 16:15Meeting summary and Actions 16:30Meeting Close 3

4. 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 4

5. EFSPI - Our members SFdS SSL APF DSBS PSDM BIAS PSI SBS/BVS BBS FMS 5

6. 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 6

7. EFSPI website www.efspi.org

8. 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 8

9. 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 9

10. 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 10

11. End of meeting 11

12. 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 12