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. 

What does this document cover?

1. Introduction

2. Deliverables

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

• Medicines and Healthcare products Regulatory Agency – ADR IT reporting system
• Spanish Agency of Medicines and Medical Devices – Integration wither other systems
• Danish Medicines Agency – Implementation of business rules

Target audience

The target audience is primarily pharmacovigilance staff working at EU National Competent Authorities.

Duration

46 page pdf