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This training course covers the use of the ISO ICSR/ICH E2B(R3) format and related ISO standard terminology for pharmaceutical form and route of administration for reporting individual cases of suspected side effects to EudraVigilance.
It is is aimed at all EudraVigilance users who have to report and analyse suspected adverse reactions in the pre- and post-authorisation phase. This includes:
Using the ISO ICSR/ICH E2B(R3) format and related terminologies becomes mandatory on 30 June 2022. For more information, see:
Sumber : https://www.ema.europa.eu
It is is aimed at all EudraVigilance users who have to report and analyse suspected adverse reactions in the pre- and post-authorisation phase. This includes:
Using the ISO ICSR/ICH E2B(R3) format and related terminologies becomes mandatory on 30 June 2022. For more information, see:
Sumber : https://www.ema.europa.eu