EMA Information Day on Services and Systems in Pharmacovigilance
Preparing for Business Change

New European Union (EU) Pharmacovigilance legislation foresees various information systems to enhance pharmacovigilance, particularly to support the
collection, management and analysis of data, information and knowledge. These systems will contribute to the promotion and protection of public health through optimisation of the safe and effective use of medicines. They should also facilitate pharmacovigilance, delivering rationalisation and efficiency gains and to improve the relevant business functions to maximise the benefits for stakeholders.
This information day is primarily aimed at providing marketing-authorisation holders (MAHs) with information on the development of the enhanced systems, helping MAHs prepare for the business change to come and to allow detailed discussions on recently launched services.
The topics to be addressed relate to key system and service developments including – new functionalities for adverse drug reaction reporting (including discussion of the Change Management Plan), medical literature monitoring, the database of medicinal products (Article 57) as well as the Periodic Safety Update Report (PSUR) Repository.