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FREE WEBINAR: RBQM OF CRITICAL DATA: Insights and Strategies from CRO-Biostatisticians


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  • Date: 28-September 2023
  • Time: 9 AM EST/3 PM CET/4 PM IDT/3 PM SA
  • Webinar description:
    • Join Sharon and Paul, Bioforum’s leading biostatisticians to discuss their experiences with the Risk-Based Quality Management (RBQM) and review of critical trial data. During the webinar we will demonstrate flexible strategies to support varying trial and customer requirements around critical data related processes.
  • Agenda:
    • Introduction to RBQM and critical data
    • Biostatistician’s perspective on critical data
    • Factors that complicate critical data identification and review
    • CRO approach to RBQM of critical data
    • Critical data review examples


  • Short overview of presenter’s experience:
    • Sharon Rossouw; Director, Biostatistics
      • Overview: A biostatistician with over 25 years of experience providing biostatistical and medical writing services to the pharmaceutical industry and academic institutions. Sharon was one of the founders of the CRO data services industry in South Africa.
      • Sharon holds a strong passion for nurturing the growth of biostatisticians and statistical programmers, with a particular focus on advancing process development and its effective implementation.
    • Paul Malan; Vice President, Biostatistics
      • Overview: Paul has 20 years of experience in planning and executing clinical trials, study designs, statistical analysis, and reporting. He began his career working for IQVIA as a statistician in 2003. Over the years, Paul held roles of increasing responsibility, moving up the ranks to serve as Country Manager for the IQVIA Biostatistics and Statistical Programmers in South Africa.
      • In addition, Paul led a major FSP program for IQVIA, overseeing the work of more than 235 biostatisticians and statistical programmers dedicated to a large, multinational pharmaceutical company.



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