Sponsors of clinical trials must submit reports of suspected unexpected serious adverse reactions to EudraVigilance, the electronic system for managing and analysing information on suspected adverse reactions to medicines in the European Economic Area (EEA).
In this section
In other sections
Sponsors should also consider the regulatory information in the sections below:
- Good pharmacovigilance practices: see Modules I (Pharmacovigilance systems) and II (Pharmacovigilance system master file)
- Patient registries
- Risk management
- Pre-authorisation guidance - see section 3.4 on pharmacovigilance system master file (PSMF) and Eudravigilance
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