Early Bird deadline - 4th September

Are you estimating what you think you are? De-mystifying Estimands

Monday 28th September 2015, GSK, Stevenage, Hertfordshire, UK

Controversy and confusion exist on the definition and selection of appropriate estimands in the clinical trial context. As a result the ICH Steering Committee endorsed a final Concept Paper in October 2014 with the goal of developing a new regulatory guidance, suggested to be an Addendum to ICH E9. The aim of the addendum is to promote harmonised standards on the choice of estimands in clinical trials and an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data. A working group sponsored by ICH has been established to develop the addendum and is due to report findings in December 2015. This meeting will provide a forum to hear about the latest developments and discussions on this topic.  Speakers include members of the ICH working group as well as representatives from academia, European regulatory bodies and industry. The day will end with a panel discussion including all speakers.

9:00am to 5:30pm

Presenters include:

Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK

Ann-Kristen Leuchs (to be confirmed)
Federal Institute for Drugs and Medical Devices, Bonn, Germany

Chrissie Fletcher
Executive Director, Global Biostatistical Science, Amgen Ltd, UK

Frank Bretz
Global Head Statistical Methodology group, Novartis, Basel, Switzerland

James Carpenter
Professor, London School of Hygiene and Tropical Medicine, UK

James Roger
Director, LiveData (UK) Ltd

Registration Costs 

Fee includes lunch & refreshments

Registration on or before 4th September
PSI Member £120 (plus VAT)  
Non-Member £160 (plus VAT)
Academic £60 (plus VAT)

Registration after 4th September
PSI Member £160 (plus VAT)  
Non-Member £220 (plus VAT)
Academic £90 (plus VAT)

To register visit www.psiweb.org > Events > PSI Events  

For information regarding the scientific content, contact:
Carly Barnett 
Tel: +44 208 990 3781
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Egbert Biesheuvel 
Tel: +31 6 46869728
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