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...March ema rev eu individual case safety report icsr implementation guide first version adopted by pharmacovigilance risk assessment december committee prac revision agreed member states governance structure for june the business team of submitted to eudravigilance expert working group october information clinical trials facilitation ctfg nov january oversight february it directors contains following updates deletion references ich eb r as appropriate in view mandatory use iso standard based on modalities new guidance edqm terms routes administration and dosage forms update registration process legal general data protection regulation gdpr i e dpr rules related no gateway protocol have been removed en health informatics reports icsrs part human pharmaceutical reporting requirements see websites contact details european medicines agency www europa is heads agencies hma an union reproduction authorised provided source acknowledged table contents a introduction b structures processes inter...