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

Save the dates already now for this unique two-day seminar arranged by The Embassy of Denmark in Washington in collaboration with the U.S. Food and Drug Administration (FDA)

Register by April 25th! See instructions below.

This FDA seminar, held in Copenhagen, will focus on the latest developments and use of data and technology in device and drug development in the following sessions

  • Cybersecurity (latest guidance, NIST framework, ecosystem, expectations, data privacy)
  • Apps working with drugs (what are they, regulatory science/use of, Apps & enforcement)
  • Interoperability (multi-vendor interoperable ecosystem, responsibility and expectations)
  • Drug delivery devices (developments, managing connectivity, regulatory science)
  • Clinical Trials (wearables, commercial grade v. medical grade, assessing endpoints)
  • Medical Device Development Tools (what is it/how to use)
  • CDRH Patient Preference Initiative (gathering information, regulatory decision making)
  • General Wellness (definition, guidance document, affect in device regulation)

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 chrfre@um.dk for more details.


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