Skip to main Content

Exchange of Information between PV Assessors and PV Inspectors

WP7 created a best practice guidance document and an e-learning module focusing on the topic of exchange of information between pharmacovigilance (PV) assessors and inspectors.

Exchange of Information between PV Assessors and PV Inspectors Best Practice Guide

This best practice guide aims to provide practical guidance on how National Competent Authorities (NCAs) who have separate departments or teams for the conduct of pharmacovigilance assessment and inspections can effectively exchange information within their NCA to maintain a high level of public health protection.

What does this document cover?

Best Practice Guide document split into seven sections:

1. Introduction

2. Recommendations for the exchange of information between PV departments and PV inspectors

3. Best practice in accessibility and sharing information between PV departments and PV inspectors

4. Technical training in relation to PV topics

5. Conclusion

6. References and related documents

7. Annexes

Annex 1. Checklist for information sharing

Annex 2. The Agency for Medicinal Products and Devices (HALMED) of Croatia non-compliance tracking sheet

Annex 3. The MHRA report for overview of MAH compliance with ICSR reporting

Annex 4. The Italian Medicines Agency (AIFA) template to request a pharmacovigilance inspection

Annex 5. The MHRA rolling programme of training presentations of Vigilance and Risk Management of Medicines (VRMM)           

Target audience

The target audience is primarily pharmacovigilance staff working at EU NCAs.

Duration

39 pages PDF. 

Click here to access this document.


Good practice in the exchange of information between pharmacovigilance assessors and pharmacovigilance inspectors within NCAs e-learning

This e-learning module is addressed to pharmacovigilance staff at NCAs – including new starters and existing staff, and aims to increase their knowledge of the importance of information sharing between pharmacovigilance assessors and pharmacovigilance inspectors.

What does this e-learning module cover?

1. Introduction

2. Types of Marketing Authorisation Holder compliance information

3. How to access Marketing Authorisation Holder compliance information

4. Sharing information

5. Using a checklist to aid activities

Target audience

The target audience is primarily pharmacovigilance staff working at EU NCAs.

Duration

10-12 minutes completion time.

Click here to access this e-learning module.



Our Progress
90%