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| Contact |
800 Enterprise Road, Suite 200
Horsham, Pennsylvania
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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?
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