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STATISTICAL HOT TOPICS IN SCIENTIFIC ADVICE
Session Chair(s)
Robert Hemmings, MSc
Partner
Critical Path Institute, United States
This session is intended to focus on statistical subjects that have been recently of particular interest in the regulatory arena. The “hot topics” are presented as a case-study for recurrent event data in cardiovascular diseases, multiplicity issues in the context of a European regulatory guideline and clinical development considerations when different agencies require different primary endpoints.
Speaker(s)
Recurrent Event Data Approaches in Cardiovascular Outcome Trials
Mouna Akacha, PhD
Novartis Pharma AG, Switzerland
Group Head of Statistical Methodology
Feedback from the EMA 2012 Workshop on Multiplicity Issues in Clinical Trials
Norbert Benda, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Head of Biostatistics and Special Pharmacokinetics
Clinical Development Considerations when Different Agencies Require Different Primary Endpoints
David Wilson
AstraZeneca, United Kingdom
Statistical Science Director
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