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EMA closes the circle between ICSR and XEVMPD by requiring the ISO IDMP´s controlled vocabularies also for ICSRs

by Ursula Tschorn | Feb 8, 2015 | EMA

The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union (EU). The so-called ISO ICSR standard improves the reporting of suspected side effects...
    Clinical Trials Extended Eudravigilance Product Dictionary - XEVMPD Abbreviations ICSR ISO IDMP Standards Structured Product Labeling - SPL IDMP Solutions Pharmacovigilance E-Subscription pharmazie.com Database




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