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Home News About EFSPI Statistics Leaders Meetings SIGS Publications Events Activities Links Advertisements Contact Us Members

EFSPI Meetings

1st EFSPI Workshop on Regulatory Statistics

 

Date: 12-13th September 2016

Venue:

Biozentrum,
University of Basel,
Klingelbergstrasse 50/70,
CH - 4056 Basel
Switzerland

 

Flyer

 

Presentations

1.0. Tom Permutt - The Per Protocol Principle
1.2. Nobert Benda & Frank Petavy - Estimands: One Way Forward
1.3. Mouna Akacha - Estimands: Are we estimating what we intend to estimate?
2.1. Ann Kristine Leuchs - Regulatory considerations on estimands in pain studies
2.2. Kaspar Rufibach & Hans Ulrich Burger - Estimands for time to event endpoints in oncology and beyond
2.3. Chrissie Fletcher - Incorporating estimands in the clinical trial protocol
2.4. Christoph Gerlinger - Some Thoughts on Estimands in a Chronic Pain Indication
3.2. Kristina Weber - On the road to clinical extrapolation
3.3. Steffen Ballerstedt & Thomas Dumortier - Supporting a Pediatric Investigational Plan in liver transplantation
4.1. David Wright - Practical Benefit Risk Assessment
4.2. Alexander Schacht - What's going on in benefit-risk and what is our role as a statistician?
4.3. George Quartey - Benefit-Risk Assessment via Case Studies: Key Considerations & Best Practices
5.1. EFSPI Lamerz - The role of statistics
5.2. Bruno Boulanger - Assessment of analytical biosimilarity
6.1. Norbert Benda - Quality issues in biosimilars
6.2. Valentine Jehl - Short Topics: Quantitative Safety and Epidemiology
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© 2021 European Federation of Statisticians in the Pharmaceutical Industry. The association is registered in Denmark– CVR Nummer: 39780909
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