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Change is Coming… Getting the Questions Right in Clinical Development
Session Chair(s)
Jürgen Kübler, PHD
Owner
Quantitative Scientific Consulting, Germany
The need for greater clarity in the articulation of the scientific questions to be answered with randomised clinical trials has recently resulted in regulations that aim at the development of clear scientific questions as a prerequisite of adequate study design and analysis. The session will discuss challenges and opportunities for clinical development both for the evaluation of efficacy and safety as well as implications on benefit-risk evaluations and product labeling.
Speaker(s)
Getting the Questions Right in Efficacy
Wolfgang Kothny, MD
Novartis Pharma AG, Switzerland
Global Head Clinical Sciences
Getting the Questions Right in Safety
Reinhard Fescharek, MD
CSL Behring GbmH, Germany
Vice President
Implications on Benefit-Risk and Labelling
Robert Hemmings, MSC
Critical Path Institute, Netherlands