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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