FDA Seminar on Data and Technology

The Danish embassy in Washington DC and the U.S. Food and drug Administration (FDA) presents a two-day seminar in Copenhagen on 9 -10 May. The Seminar will focus on data and technology in device and drug development.

The Embassy of Denmark in Washington, DC is proud to present again in Copenhagen its unique two-day seminar in collaboration with the U.S. Food and Drug Administration (FDA).
 
Focus on Data & Technology
This seminar 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 

Seating is limited, so indicate your interest now by replying to:
 
Elizabeth Dempsey Becker
elibec@um.dk
 

Kontakt

Christian Fomsgaard Johansen
Kommunikationschef
+45 4918 4704