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