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EFSPI activities


Event Date File
EFSPI - Generating Evidence for Health Technology Assessment September 2014 View Document
EFSPI - Survival Analysis and it's Applications in Drug Development November 2013 View Document
EFSPI/PSI Structured Benefit Risk Assessment - 17th September 2013 - London September 2013 View Document
EFSPI/PSI Workshop EMA Clinical Trial Data Transparency – 22nd August, London August 2013 View Document
Health Technology Assessment - Joint BBS/EFSPI Seminar Programme On June 4th 2013, the EFSPI and BBS organized a one day meeting on Health Technology Assessment. Over 115 attendees with various backgrounds attended this meeting. June 2013 View Document
European Statistical Meeting on Subgroup Analysis
Friday 30th November 2012, Brussels
Subgroups analyses are important for a comprehensive assessment of confirmatory trials in marketing authorisation application. Indeed, the CHMP is currently preparing a guideline on this topic. This meeting aims to bring together statisticians from regulatory agencies, academia and the pharmaceutical industry, to gain an insight into current thinking with regards to methodology and guidelines.
November 2012 View Document
Joint European Statistical Meeting - EFSPI/BBS/MSB - Modelling and Simulation and applications to longitudinal data
Basel, Switzerland, 13th September 2012
Modelling and Simulation is a broad area appealing to many quantitative scientists and increasingly applied in clinical drug development. The meeting will include presentations on the role of M&S in drug development as well as contributions focusing on applications of M&S to longitudinal data.
September 2012 View Document
Joint European Workshop FMS/EFSPI/DSBS: Benefit-Risk Assessment Methodology Workshop
Malmo, Sweden, 7th June 2012
An increase in the use of quantitative Benefit-Risk Assessment methods has been proposed to aid in the evaluation of new medicinal products by regulatory bodies and reimbursement committees throughout the world. This workshop will provide a forum to hear about the latest developments in the applications of these methods from a world-leader in this area – keynote speaker Larry Phillips -- from representatives of European regulatory bodies, and from practitioners in the pharmaceutical industry and academia. The workshop includes presentations from each of these perspectives, as well as an opportunity to interact with the speakers in a panel discussion.
June 2012 View Document
European Statistical Meeting: Advances in the Treatment of Missing Data
Brussels,18 November 2011
The treatment of missing data continues to be a challenge in the analysis of clinical trials, potentially affecting the integrity and validity of trial results if not handled appropriately. This meeting aims to bring together statisticians from regulatory agencies, academia and the pharmaceutical industry, to gain an insight into recent advances in methodology and guidelines.
November 2011 View Document
EFSPI-SFdS-B&S Joint European Statistical Meeting
Paris, 18-19 November 2010
The European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmacy and Health Group of the SFdS (“Société Française de Statistique”, French Society for Statistics) held their joint one and a half day European Statistical Meeting in Paris, on 18 and 19 November 2010
The following topics were discussed: meta-analyses, multi-regional development plans, biomarkers and the future of the European statistical guidance.
November 2010 View Document
Joint EFSPI-BBS meeting, Basel, 24th June 2010
European Statistical Meeting on Oncology
The meeting was aimed at statisticians who have an interest in Oncology or wish to gain a greater understanding.
June 2010 View Document
Joint EFSPI-MHRA meeting, London, 29th and 30th March 2010
Statistics at the frontier of drug development
The meeting intended to provide a unique opportunity for discussion amongst industry, regulatory and academic scientists.
May 2010 View Document
European Statistical Meeting on Meta-Analysis
The Basel Biometric Section (BBS) in cooperation with the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) held a one day European Statistical Meeting on Meta Analysis.
Speakers from industry, academia and regulatory shared their views on Meta - Analysis.
June 2009 View Document
European Statistical Meeting on Non-Inferiority
Verona, Italy, November 20th 2008
This meeting was a joint venture between EFSPI, BIAS and SSFA.
Non-inferiority trials have been around for many years, but are still controversial. Experts from industry, academia and regulatory bodies have presented and discussed a range of issues concerning these trials.
November 2008 View Document
Joint PSI-EFSPI Conference, Brussels, May 18th-21st, 2008 This was a European Conference aimed at Statisticians in the Pharmaceutical Industry.
Many opinion leaders from industry, academia and regulatory have spoken. The conference contained many parallel sessions to provide variety and free tutorials on Adaptive and Sequential Designs.
June 2008 View Document
EFSPI/BBS joint meeting on Adaptive Designs in Drug Development Basel, June 15th, 2007 June 2007 View Document
EFSPI Scientific Meeting on Adaptive Randomisation – Today and Tomorrow December 2006 View Document
EFSPI session at annual PSI Conference, Bristol May 2003 View Document
3nd International Workshop on Statistical Methodology in Non-Clinical R&D, Barcelona, Sep 2002 August 2002 View Document
Henry Stewart briefing: "Coping with the Conflicting Requirements for Control", London, Oct 2001 September 2001 View Document
2nd International Workshop on Statistical Methodology in Non-Clinical R&D, Montreux, Sep 2000 August 2000 View Document
DIA Workshop on "New ICH Guideline on Choice of Control Group in Clinical Trials: The Key Statistical Issues", Brussels, Nov 1999 October 1999 View Document
ISI 52th session in Helsinki, incl. EFSPI presentations, Aug 1999 July 1999 View Document
1st International Workshop on Statistical Methodology in Non-Clinical R&D, Nice, Nov 1998 October 1998 View Document
DIA Workshop on "New ICH Guideline on Statistical Principles for Clinical Trials", Nice, Oct 1997 September 1997 View Document
DIA Workshop on "Statistical Methodology in Clinical Research & Development", Copenhagen, Apr 1996 March 1996 View Document
DIA Workshop on "Statistical Methodology in Non-Clinical & Toxicological Studies", Bruges, Mar 1996 February 1996 View Document
Presentation on Annual DIA Meeting, Washington DC, June 1994 May 1994 View Document
DIA Workshop on " A European concept for Good Statistical Practice in Global Drug Development", Edinburgh, Apr 1994 March 1994 View Document
DIA Forum on "European Biostatistics Guidelines", London, Oct 1993 September 1993 View Document
Presentation on ISI 49th session in Florence, Aug 1993 July 1993 View Document
EFSPI_MHRA_2010
EFSPI_BBS_Oncology_2010
EFSPI_SFdS-B&S_2010
EFSPI/PSI/PDSM/BMS Advances in the Treatment of Missing Data Nov 2011
EFSPI/FMS/DSBS
EFSPI/BBS/MSB Modelling & Simulation Sept 2012
EFSPI/Subgroup Analysis
HTA/Joint BBS/EFSPI Seminar
EFSPI/PSI - EMA Clinical Trial Data Transparancy - August 2013
EFSPI/PSI - Structured Benefit-Risk Assessment - September 2013 - London
EFSPI - Survival Analysis and it's Applications in Drug Development
EFSPI - Generating evidence for Health Technology Assessment