GVP – Module VIII: Post-authorisation safety studies

REVISION 3 in force from: 13. 10. 2017

MODULE - FULL TEXT

GVP – Module VIII: Post-authorisation safety studies (full text)

MODULE - DETAILS

VIII.A.: Introduction

VIII.A Introduction

VIII.A.1. Terminology

VIII.B. Structures and processes

VIII.B.1. Principles

VIII.B.2. Study registration

VIII.B.3. Study protocol

VIII.B.4. Reporting of pharmacovigilance data to competent authorities

VIII.B.5. Publication of study results

VIII.B.6. Data protection

VIII.B.7. Quality systems, audits and inspections

VIII.B.8. Impact on the risk management system