FDA Combination Products Seminar

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FDA Combination Products Seminar

Date: 27 Apr 2016 - 28 Apr 2016, 8:00 - 17:00

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

FDA Seminar on Combination Products

Registration deadline – April 12, 2016
Seating is limited, early registration is advised.

View agenda and register by completing the form here: FDA Seminar on Combination Products – April 27-28 2016 – Announcement Program Registration,  and emailing it to Justin Origen at jusori@um.dk.


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) and
its Office of Combination Products (OCP) and the Center for Devices and Radiological Health
(CDRH). The seminar provides the latest updates and forward-thinking from FDA speakers.

The program has been developed to provide a review/update on such topics as:

  • Role of OCP
  • Classification and assignment
  • Premarket review issues
  • Human factors
  • cGMP for combination products
  • Postmarket adverse events
  • Case studies on regulatory considerations
  • Hot topics

Why Attend

  • An opportunity for one-on-one meetings with FDA officials
  • Understand the critical changes to create successful strategies in the US
  • Benchmark your regulatory strategy against agency requirements
  • Network with peers during lunch and refreshment breaks

Registration fee

7.500 DKK per person which includes two-day seminar participation, materials, lunches/refreshments, and individual consultations with FDA officials. A certificate of participation will be issued after the seminar.

Information & Registration

See enclosed program, speaker biographies, and registration form.

Questions?

Contact Justin Origen at jusori@um.dk

Learn more about the FDA Office of Combination Products here.

 

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