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.
The target audience is primarily pharmacovigilance staff working at EU National Competent Authorities.
What does this document cover?
2. Additional monitoring
4. Annexes (case studies: UK - MHRA, Czech Republic - SKUL, Translation of the NOMA black triangle poster)
20 page pdf.
Click here to access this document.
What does this e-learning module cover?
1. Additional monitoring introduction
2. Case study 1: UK (MHRA)
3. Case study 2: Czech Republic (SUKL)
15 - 20 minutes completion time.
Click here to access additional monitoring e-learning module.