IT Systems for ADR Reporting: Best Practice Guide
This best practice guide aims to provide guidelines that can be used by Member States (MSs) to increase knowledge about adverse drug reaction (ADR) IT systems. The guidance document provides insight into ADR IT systems used and into good practice regarding ADR reporting. Materials developed should facilitate improved skills, awareness, education and capability of reporters reporting an ADR to national reporting systems.
What does this document cover?
3. Basic systems
- SCOPE findings
- ADR IT systems
4. A well-developed and operative system
- System features
5. Advanced systems
- Advanced systems features
6. Case studies
The target audience is primarily pharmacovigilance staff working at EU National Competent Authorities.
46 page pdf
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