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Regulatory Submissions, Information, and Document Management Forum


Session 3: Other Regions Update

    Session Chair(s)
      Michiel  Stam

      Michiel Stam

      • Regulatory Information Scientist
      • eCTDconsultancy B.V., Netherlands
    Receive updates about developments in other regions including Canada, European Union, and Japan. Hear agency and industry representatives speak about electronic submissions, development of new data standards, local implementation plans, and Health Authority IT strategies.
    Speaker(s)
      Vikesh  Srivastava

      Speaker

      Vikesh Srivastava

      • Associate Director, Business Informatics Division, HPFB
      • Health Canada, Canada
      Mickel  Hedemand, MSc

      Speaker

      Mickel Hedemand, MSc

      • Special Advisor, Medicines Licensing, Workflow
      • Danish Medicines Agency, Denmark
      Harv W Martens

      Speaker

      Harv W Martens

      • Technical Expert for JPMA on ICH M2 and M8 Expert Working Groups
      • United States