Whitepaper: Implementation of EUDRAVIGILANCE data analysis system (EVDAS) in signal detection
This whitepaper outlines how to prepare for a scheduled inspection
This whitepaper outlines how to prepare for a scheduled inspection
On 22nd November 2017, the European Medicine’s Agency (EMA) launched the new Eudravigilance system which was followed by the launch of EVDAS on 22nd February 2018 and a list of active substances on the pilot scheme. Marketing Authorisation Holders (MAHs) with products on the list are required to implement EVDAS as part of routine signal detection activities.