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An active approach to comparisons of ADR reports from patients and HCPs 

The purpose of this document is to advocate for an active approach to performing comparisons of adverse drug reaction (ADR) reports from healthcare professionals (HCPs) and patients across European Union Member States and to provide national competent authorities (NCAs) with case studies as examples of different approaches to research. The case studies were chosen to illustrate different settings in which the research was performed. By using these studies as a reference point, NCAs can choose the most suitable approach they wish to take to perform their own studies.

What does this document cover?

1. Introduction

2. SCOPE survey results

3. Case studies of an active approach to scientific research into comparison of ADR reports from HCPs and patients

  • Case study – Italy
  • Case study – Denmark
  • Case study – The Netherlands
  • Case study – United Kingdom

4. Call for action and conclusions

5. Annexes  

Target audience

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

Duration

Document: 39 page pdf.

Click here to access the white paper on active approach to comparisons of ADR reports from patients and HCPs.

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