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Session 4: KEY TOPICS IN REGULATORY STATISTICS
Session Chair(s)
Norbert Benda, PhD
Head of Biostatistics and Special Pharmacokinetics
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Hans Ulrich Burger, PhD
Senior Director of Biostatistics
F. Hoffmann-La Roche Ltd., Switzerland
This session will pick up two relevant topics which are important for regulatory bodies as well as for industry. For each of the topics we will have one presentation from a more regulatory view and a panel discussion. The first topic will deal with issues in developing new therapies in small populations, rare diseases and paediatric indications. The second issue will discuss issues around censoring for time to event analyses and what the right primary analysis should be.
At the end of the session panel discussion with Q&A will take place.
Speaker(s)
Overview on Issues in Developing New Therapies in Small Populations, Rare Diseases and Paediatric Indications
Kit B. Roes, PhD
University Medical Center Utrecht, Netherlands
Professor of Clinical Trial Methdology
20 Years of ICH E4 -Dose-Response / Dose-Finding Quo Vadis?
Andrew Peter Grieve, DrSc, PhD, MSc
Aptiv Solutions, Germany
Senior Vice President Clinical Trial Methodology
Statistical Analysis in Alzheimer’s Disease
David Brown, MSc
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of Statistics Team, Healthcare, Quality and Access
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