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Xinjiang Plaza

Aug 14, 2016 8:30 AM - Aug 15, 2016 5:30 PM

Attn: Miss Ying Zhao, No. 7 Sanlihe Road, 100027 Beijing, China

2016 Quantitative Science Forum

Overview

Since 2013, DIA China held 3 editions of Quantitative Science Forum, which were successful event series that provided a multi-functional forum within China to discuss quantitative science topics in pharmaceutical product development. DIA and China Clinical Trial Statistics (CCTS) Working Group will co-hold the 4th “quantitative science forum” in 2016 again. In the last few years, we have seen significant advance in quantitative decision making and regulatory sciences. Globally, ICH has gone through a significant reform and has established multiple working groups including the revision of the ICH E6 (GCP), E9 (Statistics), M4E (CTD efficacy and benefit-risk), and new guidance ICH E17 (multiple regional clinical trial). In China, CFDA also issued a new guidance on MRCT and a revised draft guidance on statistics principle. Nowadays, the Chinese industry faces greatly severe test on clinical trial data self-inspection and audit. The 2016 forum, with the theme of “Quantitative Sciences and New Regulatory Guidance”, will interpret the new regulatory guidance and share knowledge of quantitative issues in safety, efficacy, risk- benefit, and potentially cost-effective utilization to provide scientific and standardized statistics for the qualified or excellent clinical trials, as well as how to provide complete, effective data with high quality. Dedicated sessions featuring consensus from the key statistics opinion leaders and experts from CCTS will be presented to the participants.

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Featured topics

  • China Statistics Guidance
  • China MRCT guidance and ICH E17
  • China Data management guidance/ regulation interpretation
  • New CDISC standards and trends
  • ICH Risk-benefit guidance and quantitative evaluation on risk-benefit
  • Safety data management and statistical analysis
  • ICH E6 update
  • Statistical methods in Biosimilar
  • Updated Progress in Scientific Programming
  • Elevation of the Quantitative Profession in Drug Development

Featured

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Continuing-Education

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Who should attend?

  • Statisticians
  • Clinicians
  • Data Management Professionals
  • Regulatory Scientists
  • Quantitative and Clinical Scientists in Academia
  • Quantitative and Clinical Scientists in Regulatory Agencies
  • Scientific Programming Professionals

Learning objectives

  • A better understanding of the new regulatory guidance and its impact on the implementation of quantitative science in drug development
  • Discuss different ways to evaluate pharmaceutical products from multiple angles in in the regulatory environment
  • Discuss the importance of guidance, standards, and scientific validity in medical product development

Program Committee

  • Feng Chen, PHD
    Feng Chen, PHD Professor, Dean
    School of Public Health, Nanjing Medical University, China
  • William Wang, PHD
    William Wang, PHD Executive Director
    Merck & Co, Inc, United States

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