Individual case safety report (ICSR) information day

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TitleIndividual case safety report (ICSR) information day
Date26/04/2016 - 26/04/2016
LocationEuropean Medicines Agency, London, UK
SummaryThis 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.

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Name Language First published Last updated
Agenda and registration form - Individual Case Safety Report (ICSR) information day: 26 April 2016 (English only) 11/03/2016  

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