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EMA/DIA EU Statistics Forum

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Overview

Analyses of observational data have played a central role in assessing post authorisation drug safety for many years. However, systematic collection of clinical practice records in electronic form has increased the range and quality of possible analyses and the use of such data in other areas of clinical research. This raises important questions for those designing and conducting both pre- and post-approval research and those attempting to base regulatory decisions on the results.

Registration fees for this Information Day

  • Standard :  € 600.00
  • Academia/Charitable/Government/Non-Profit (full time):  € 300.00
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      What you will learn

      • How to select the most reliable methods from the diverse range of study designs used in observational analyses

      • Which types of questions can be addressed using observational data alone and which require interventional techniques and, in particular, randomisation of alternative treatments

      • How the observational data can best be used to enhance and extend the current methods used in clinical research

      • Follow-up through routine clinical data collection
      • Value of additional non-randomised control data: concurrent or historical

      • How to assess research based on observational studies and, in particular, how to pre-specify criteria of ‘success’ in an observational study in a way that would allow confident design of a research programme to meet regulatory requirements

        

      Who should attend?

      Statisticians and researchers involved in drug research based on observational data such as Real-World Data Specialists, Statisticians in R&D, Epidemiologists, and PRAC members

       

      Program Committee

      • Sigrid  Behr, PhD
        Sigrid Behr, PhD Group Head Quantitative Safety & Epidemiology
        Novartis Pharma AG, Switzerland
      • Hans Ulrich  Burger
        Hans Ulrich Burger Senior Director of Biostatistics
        F. Hoffmann-La Roche Ltd., Switzerland
      • Stephen JW Evans, MSc, FRCP
        Stephen JW Evans, MSc, FRCP Professor of Pharmacoepidemiology
        The London School of Hygiene & Tropical Medicine, United Kingdom
      • Jürgen  Kübler, PhD
        Jürgen Kübler, PhD Quantitative Scientific Consultant
        QSciCon, Germany
      • Jim  Slattery, MSc
        Jim Slattery, MSc Statistician, Pharmacovigilance Department
        European Medicines Agency, United Kingdom
      • Andrew  Thomson
        Andrew Thomson Statistician, Biostatistics & Methodology Support Office
        European Medicines Agency, United Kingdom
      • Richardus J Vonk
        Richardus J Vonk Head of Research and Clinical Sciences Statistics
        Bayer AG, Germany
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      +41 61 225 51 51


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