GVP – Module V: Risk management systems

REVISION 2 in force from: 31. 3. 2017

MODULE - FULL TEXT

GVP – Module V: Risk management systems (full text)

MODULE - DETAILS

V.A. Introduction

V.A. Introduction

V.A.1. Terminology

V.B. Structures and processes

V.B.1. Principles of risk management

V.B.2. Responsibilities for risk management

V.B.3. Overview of the format and content of the risk management plan (RMP)

V.B.4. RMP part I “Product(s) overview”

V.B.5. RMP part II “Safety specification”

V.B.6. RMP part III “Pharmacovigilance plan (including post-authorisation safety studies)”

V.B.7. RMP part IV “Plans for post-authorisation efficacy studies”

V.B.8. RMP part V “Risk minimisation measures (including evaluation of the effectiveness of risk minimisation activities)”

V.B.9. RMP part VI “Summary of the risk management plan”

V.B.10. RMP part VII “Annexes to the risk management plan”

V.B.11. The relationship between the risk management plan and the periodic safety update report

V.B.12. Quality systems and record management

V.C. Operation of EU network

V.C.1. Requirements for the applicant/marketing authorisation holder in the EU

V.C.2. Submission of a risk management plan to competent authorities in the EU

V.C.3. Assessment of the risk management plan within the EU regulatory network

V.C.4. Transparency