Individual case safety report (ICSR) information day
EventCorporate
Date
- Tuesday, 26 April 2016, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
This information day will provide pharmacovigilance experts of medicines regulatory authorities and marketing authorisation holders an update on the latest developments on the implementation of the new ICSR format as part of the enhanced EudraVigilance functionalities, the revision of the guideline on good pharmacovigilance practices (GVP) 'Module VI - Management and reporting of adverse reactions to medicinal products' as well as plans for the future integration with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards.