GVP – Module I: Pharmacovigilance systems and their quality systems

MODULE - FULL TEXT

Module I: Pharmacovigilance systems and their quality systems (full text)

MODULE - DETAILS

I.A. Introduction

I.A. Introduction

I.B. Structures and processes

I.B.1. Pharmacovigilance system

I.B.2. Quality, quality objectives, quality requirements and quality system

I.B.3. Quality cycle

I.B.4. Overall quality objectives for pharmacovigilance

I.B.5. Principles for good pharmacovigilance practices

I.B.6. Responsibilities for the quality system within an organisation

I.B.7. Training of personnel for pharmacovigilance

I.B.8. Facilities and equipment for pharmacovigilance

I.B.9. Specific quality system procedures and processes

I.B.10. Record management

I.B.11. Documentation of the quality system

I.B.12. Monitoring of the performance and effectiveness of the pharmacovigilance system and its quality system

I.B.13. Preparedness planning for pharmacovigilance in public health emergencies

I.C. Operation of the EU network

I.C.1. Overall pharmacovigilance responsibilities of the applicant and marketing authorisation holder in the EU

I.C.2. Overall pharmacovigilance responsibilities within the EU regulatory network

I.C.3. Data protection in the EU

I.C.4. Preparedness planning in the EU for pharmacovigilance in public health emergencies