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USA and EUROPE Looking Ahead to 2020

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  1. Individual Case Safety Report (ICSR) standard (ISO 27953-2:2011) and the modalities on how to implement this standard, as defined in the ICH E2B(R3) guideline;
  2. Terminology on pharmaceutical dose forms and routes of administration (ISO/FDIS 11239:2012), in line with EMA’s Referential Management Service (RMS).