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Standards of evidence for regulatory decision making

  • In: Symposium D3: Benefit-risk planning through the product life cycle on Tuesday, 23 May 2017, 15:10-15:45
  • At: Stockholm (Sweden) (2017)
  • Type: Presentation
  • By: HEMMINGS, Robert (MHRA, Licensing Division, London, United Kingdom)
  • Co-author(s): Robert Hemmings: Licensing Division, MHRA, London, United Kingdom
  • Abstract:

    Regulators encourage early dialogue with companies planning strategies for global drug development, licensing and commercialisation.  That diagloue helps to define a path for the development, including standards for licensing, different methodological approaches in clinical trial design, conduct and analysis, and regulatory tools to support


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Last update 28 September 2023

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