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Tryp Barcelona Apolo

Nov 10, 2014 9:00 AM - Nov 11, 2014 4:00 PM

Avinguda del Parallel, 57-59, 08004 Barcelona, Spain

Joint DIA/AEMPS Statistics Workshop

Session 1 continued: LACK OF ADHERENCE AND THE CHOICE OF THE RIGHT ESTIMAND IN CLINICAL TRIALS

Session Chair(s)

Norbert  Benda, PHD

Norbert Benda, PHD

Head of Biostatistics and Special Pharmacokinetics, Federal Institute For Drugs and Medical Devices (BfArM), Germany

William  Malbecq, DRSC

William Malbecq, DRSC

Head of Biostatistics Europe, MSD, Belgium

Speaker(s)

Ann-Kristin  Leuchs

Ann-Kristin Leuchs

Statistician, Bfarm, Germany

Applicability and appropriateness of de-facto and de-jure estimands in drug approval

David  Brown, MSC

David Brown, MSC

Head of Statistics Team, Healthcare, Quality and Access, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Estimands and the Handling of Missing Data: Regulatory Evolution

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