FDA Seminar on Data and Technology

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FDA Seminar on Data and Technology

Date: 9 May 2017 - 10 May 2017, All Day

Host: Ministry of Foreign Affairs, Eigtveds Pakhus, Asiatisk Plads 2G, Copenhagen

This unique two-day seminar was arranged again by The Embassy of Denmark in Washington in collaboration with the U.S. Food and Drug Administration (FDA)

This FDA seminar, held in Copenhagen, has been developed to provide insights on digital health regulation, cybersecurity, QS regulation, risk management, IMDRF, CDRH initiatives among other related topics. The seminar also includes the opportunity to reserve a 1-on-1 meeting with FDA officials.

The seminar will include the following sessions

  • Digital Health Regulation
  • Digital Health Technology within Clinical Trials
  • Overview of QS Regulation
  • Risk Management
  • Advanced Topics within the Regulatory Space for Digital Health
  • IMDRF
  • Changing Landscape of Evidence Generation
  • Cybersecurity
  • Cases, New Programs and “Hot Topics”

Why Attend?

  • Opportunity for “one-on-one” meetings with FDA officials
  • Understand the critical changes to create successful strategies in the USA
  • Benchmark your regulatory strategy against agency requirements
  • Learn and network with your colleagues

Download the PDF with registration form here or contact Christian Mørch Frederiksen at chrfre@um.dk for more details.

 

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