International Workshop on Statistical Methodology in Clinical R&D

Venue: Auditorium Madrid Hotel

Location: Madrid, Spain

Event Date/Time: Oct 17, 2007 End Date/Time: Oct 19, 2007
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Description

The workshop aims to provide the opportunity to listen to and interact with key opinion leaders and influential statisticians from regulatory agencies, academia and industry across a broad range of topics pertaining to Phase I – Phase IV clinical trials.

The sessions combine new ways of looking at old problems with up-to-date contributions on current thinking from EU and US regulators. The workshop will include theoretical, philosophical and practical contributions.

Key Topics
• Joint one-day meeting of Statistics, Data Management and Medical Writing
• Statistics in oncology
• Latest regulatory developments in ‘biosimilarity’ and ‘conditional approval’
• The use of factorial designs
• Validating ‘safety’ biomarkers
• A new model for non-inferiority?

Venue

Avenida de Aragon, 400
Madrid
Spain
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