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

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