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MINISTRY OF FOREIGN AFFAIRS OF DENMARK
THE EMBASSY OF DENMARK, WASHINGTON, DC
SAVE THE DATE!
FDA Seminar – March 18-19, 2015
Copenhagen, Denmark
Eigtveds Pakhus
The Embassy of Denmark in Washington, DC is proud to present again its unique two-day FDA
Seminar in collaboration with the U.S. Food and Drug Administration (FDA) – the Center for
Drug Evaluation and Research (CDER) and the Office of Pediatric Therapeutics under the
Office of the FDA Commissioner.
Preliminary program topics
The program has been developed to provide a post-FDASIA review and update on such topics
as Compliance/Inspections, Supply Chain/Shortages, Review Process, Advisory Committees,
New Trends in Class REMS & REMS, Direction of the Pharmaceutical Quality Office,
International Collaboration, PERC updates, Trial Design & Endpoints, Extrapolation, Ethics of
Trials and more.
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
Watch for more information in the coming weeks
Seating is limited so indicate your interest now by replying to
kasohr@um.dk