Pharmacovigilance regulations and regulatory process: Pharmacovigilance in the product lifecycle

9 Outubro 2019, 19:00 • Paula Alexandra Gomes Barão de Sousa Ferreira

Fundamental concepts, drug life cycle and limitations of clinical trials

National Pharmacovigilance System

Spontaneous Reporting System – Portal RAM

European Pharmacovigilance System

Risk Management Methodologies in Pharmacovigilance

Decision Making Process and Communication

Case submission – Portal RAM