GVP – Module IV: Pharmacovigilance audits

REVISION 1 in force from: 12. 8. 2015

MODULE - FULL TEXT

GVP – Module IV: Pharmacovigilance audits (full text)

MODULE - DETAILS

IV.A. Introduction

IV.A. Introduction

IV.A.1. Terminology

IV.B. Structures and processes

IV.B.1. Pharmacovigilance audit and its objective

IV.B.2. The risk-based approach to pharmacovigilance audits

IV.B.3. Quality system and record management practices

IV.C. Pharmacovigilance audit policy framework and organisational structure

IV.C.1. Marketing authorisation holders in the EU

IV.C.2. Requirements for audit reporting in the EU

IV.C.3. Confidentiality

IV.C.4. Transparency