GVP – Module IX: Signal management

REVISION 1 in force from: 22. 11. 2017 / 22. 2. 2018 (Sections IX.C.1.1., IX.C.3., IX.C.4.)

MODULE - FULL TEXT

MODULE - DETAILS

IX.A.: Introduction

IX.A. Introduction

IX.A.1. Terminology

IX.B. Structures and processes

IX.B.1. Sources of data and information

IX.B.2. Signal detection

IX.B.3. Evaluation during signal validation and further assessment

IX.B.4. Signal prioritisation

IX.B.5. Quality requirements

IX.C. Operation of the EU network

IX.C.1. Roles and responsibilities

IX.C.2. Emerging safety issues

IX.C.3. Monitoring of EudraVigilance data

IX.C.4. Notifications and procedural options for signals detected by the marketing authorisation holder in the EU based on the continuous monitoring of EudraVigilance data

IX.C.5. Signal confirmation by the PRAC rapporteur or (lead) Member State

IX.C.6. Signal analysis, prioritisation and assessment by the PRAC

IX.C.7. Recommendations on signals from the PRAC

IX.C.8. Record management in the European Pharmacovigilance Issues Tracking Tool (EPITT)

IX.C.9. Transparency

IX. Appendix 1. Figures on the EU signal management process