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Wednesday, February 6 • 15:15 - 16:15
#S0403: Change is Coming… Getting the Questions Right in Clinical Development

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Component Type: Session

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.


Jürgen Kübler, PhD


Getting the Questions Right in Efficacy
Wolfgang Kothny, MD

Getting the Questions Right in Safety
Reinhard Fescharek, MD

Implications on Benefit-Risk and Labelling
Robert Hemmings, MS, MSc


Reinhard Fescharek

Vice President, CSL Behring GbmH
avatar for Robert Hemmings

Robert Hemmings

Statistics and Pharmacokinetics Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA)
Rob has been with MHRA for 16 years and heads up the team of statisticians and pharmacokineticists. Much of Rob’s time is spent educating colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a co-opted member of the... Read More →
avatar for Wolfgang Kothny

Wolfgang Kothny

Global Head Clinical Sciences, Novartis Pharma, Switzerland
Dr. Wolfgang Kothny is a physician who did his clinical training in the department of cardiology at the University Munich before joining the industry in 1999. Wolfgang joined Novartis in 2007 and currently is holds the Position of Global Head Clinical Sciences. Before that, he was... Read More →
avatar for Jürgen Kübler

Jürgen Kübler

Owner, QSciCon
Dr. Kübler has over 25 years of experience in the pharmaceutical industry. He has published in statistical and scientific journals, regularly gives scientific - presentations and organized various sessions at scientific conferences. He has a Masters and PhD in Statistics from the... Read More →

Wednesday February 6, 2019 15:15 - 16:15 CET
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  04 Modern Clinical Research, Session
  • Featured Topics Clinical Development
  • Tags Session