Compos AE is a system in the Compos family dedicated to documenting adverse events in the correct way. It is used for both legal requirements as well as for research and safety studies (PASS).
Adverse events must be reported to Swedish Medical Product Agency (LV). Compos AE integrates Compos DS with LV’s system and secures that reports are correctly made.
Using a standardized classification of AE gives the possibility to better understand and monitor the events, even over multiple countries.
medDRA is available for all to use in the registration, documentation and safety monitoring of medical products both before and after a product has been authorized for sale. Products covered by the scope of medDRA include pharmaceuticals, biologics, vaccines and drug-device combination products. www.meddra.org
Compos DS includes classification support and the latest medDRA coding version available. This will benefit correct reporting and keeping documentation collected at one place – at hand for research and safety study purposes.