Upcoming EFSPI/PSDM event 2017JUN23: Analysis of Safety Data in Clinical Trials

Friday June 23, 2017, Leiden (NL)

Safety data are the most common and one of the most important type of data collected in clinical trials. However, in general, the emphasis is on the efficacy data. In this meeting, we will take a look at various aspects of safety data in a clinical trial. Colleagues from industry, academia and regulatory agencies will come together to discuss latest developments for statistical analysis of adverse events, current practices in the conduct of data monitoring committees, and related topics on safety data in clinical trials. We will also hear thoughts on personalized safety analyses.

Confirmed speakers include Maria Costa (GSK), Adam Crisp (GSK), Johanna Gillhaus (or colleague, Pfizer), Bernd Heinen (JMP), Kit Roes (University of Utrecht), Gerd Rosenkranz (University of Vienna), and Robert Snijder (Astellas).

Flyer

Venue

Astellas Pharma Europe B.V.,
Sylviusweg 62,
2333BE Leiden,
Netherlands 


Register here


For more information, go to:
http://www.efspi.org


For information regarding the scientific content, contact:
Axel Krebs-Brown
Tel: +31 (0)71 545 5968
axel.krebs-brown@astellas.com

 

EVENTS 2016

Date

Title

2016
December 12016
June 24
PSDM Event “Data Sharing” 
Abott, Weesp, The NetherlandsEFSPI/PSDM Meeting “Biomarkers and Subgroups”
Astellas, Leiden, The Netherlands

 

EVENTS 2015

Date

Title

2015
September 14
Implementation of CDISC Standardization
SAS Institute, Huizen

 

PREVIOUS EVENTS

Date

Title

2013
September 02
Risk-based Monitoring: opportunities and challenges in clinical development
Astellas, Leiden
2012
November 08
Adaptive Designs in Drug Development Workshop
MSD, Oss
2012
June 19
Open Source Software in Clinical Research:
cost-saving opportunity or high-risk solution?

Julius Clinical Research B.V., Zeist
2011
November 18
European Statistical Meeting
Advances in the Treatment of Missing Data

Bristol-Myers Squibb, Brussels
2011
June 22
The Future of PSDM Disciplines
Abbott, Weesp
2010
November 25
Statistical and Practical Issues of Patient Reported Outcomes (PROs)
(including annual PSDM meeting)
MSD, Oss
2009
June 26
SETTING EQUIVALENCE MARGINS IN CLINICAL RESEARCH
(including annual PSDM meeting)
Danone Research, Wageningen

 

ARCHIVE

Date

Title

November 28th, 2008 Program Validation Issues in Clinical Research
How to validate clinical databases and one-shot programs
Schering-Plough Corporation, Oss
2008
May 22
SAE Data Reconciliation: What’s your approach?
Solvay, Weesp
2007
November 22
EDC: EXPERIENCES AND BEST PRACTICES
Xendo, Groningen
2007
October 02
PHARMACOVIGILANCE: THE CHANGING LANDSCAPE
FIGON Dutch Medicine Days 2007
De Werelt, Lunteren
2007
April 17-18
PSDM/PSI Course: Interim analysis and adaptive designs
no link to summary yet
Organon, Oss
2007
March 07
CDISC: Refresh your knowledge of the CDISC basic models
Implementation of the models: strategies and stories
Organon, Oss
2006
June 21
 Statistical and Data Management aspects of dealing with Data Safety Monitoring Boards
(including annual PSDM meeting)
Solvay, Weesp
2006
February 09
EDC Workshop
Astellas, Leiderdorp
2005
November 29
Autumn meeting BMS/ANED (incl. PSDM)
Utrecht
2005
June 15
PSDM Workshop: How to improve efficiency and quality within Clinical Data Management
Amsterdam 
archief/2005/20050615-2.htm
2005
February 3
PSDM Workshop: Recent draft ICH/ CPMP Guidelines revisited
Leiderdorp 
archief/2005/20050203.htm
2004
May 26
PSDM Workshop: Where Data Management and Statistics Meet 
Oss 
archief/2004/20040526a.htm
2003
December 2
SBS/BVS/PSDM Workshop: Challenges for the next 10 years in Biostatistics
Beerse 

archief/2003/20031202.htm
2003
November
20-21
PSDM Course: Survival Analysis 
Oss 
archief/2003/20031120.htm
2003
June 10
PSDM Workshop on CDISC
Weesp 
archief/2003/20030610.htm
2002
November 1
PSDM Workshop: Practical Issues on Statistics and Data Management 
Oss 
archief/2002/01112002.htm
2001
November
27-28
Cursus Mixed Models in Clinical Research
Oss 

archief/2001/27112001.htm
2001
October 11
Regulatory Guidelines & Clinical Statistics
Weesp 
html archief/2001/11102001.htm
2001
October 04
Data Management: System Validation & Guidelines 
CHIRON BV, Amsterdam
info, program html archief/2001/04102001.htm
2000
December 14
Clinical Data Base Management Systems & Electronic Submissions 
Weesp 
html archief/2000/14122000.htm
1997
January 23/24
”Modelling Categorical Data”
Cursus met docenten van Reading University
1996 Annual report 1996
1996 Foundation PSDM 
during BMS year meeting