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Additional Monitoring Document and E-learning module

Additional monitoring document and e-learning module aim to provide an overview of the main aspects of the additional monitoring process, summarise Member States’ (MS) experiences with regard to additional monitoring and provide an overview of examples of good practice.

Target audience

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

Identification, Management and Raising Awareness of ADR Reports for Drugs Subject to Additional Monitoring Document

What does this document cover?

1. Introduction

2. Additional monitoring

  • Identification of adverse drug reaction (ADR) reports reports for drugs subject to additional monitoring in the national ADR database
  • Management of ADR reports for drugs subject to additional monitoring
  • Raising awareness on additional monitoring
  • Measuring the impact of additional monitoring

3. Conclusions

4. Annexes (case studies: UK - MHRA, Czech Republic - SKUL, Translation of the NOMA black triangle poster) 

Duration

20 page pdf.

Click here to access this document.

Additional Monitoring e-learning module 

What does this e-learning module cover?

1. Additional monitoring introduction

2. Case study 1: UK (MHRA)

3. Case study 2: Czech Republic (SUKL)

4. Summary

Duration

15 - 20 minutes completion time.

Click here to access additional monitoring e-learning module. 

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