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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.
      Vikesh  Srivastava


      Vikesh Srivastava

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


      Mickel Hedemand, MSc

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


      Harv W Martens

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