Registry Workshop - Preparing for Future Requirements

The large claims databases in US are extensively being used, not least due to the large amount of data. Extraction of data directly from patient records is under development. In addition to medicine post approval studies, US is now implementing “device post approval studies”. Prospective data collection in “pregnancy registries” is currently ongoing in 50 product specific registries. FDA are now placing “pregnancy registries” in the Nordic countries with a population of almost 30 mill. People. Why go to a region with 10 times less people than in USA? This session will share the position of FDA, and give an insight in the benefit/challenges using data in US versus Nordic Countries, which in many ways exemplifies the current status for Registries/Databases.