Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory
Risk Management
Center for Biologics Evaluation and Research
Center for Devices and Radiologic Health
Prescription Drug User Fee Act
Prescription Drug User Fee Act: Five-Year Plan
Food and Drug Administration Act (FDAAA) of 2007
FDA Reauthorization Act of 2017
What is Expected from Drug Companies by the FDA?
What is Expected from Consumers and Healthcare Professionals by the FDA?
Chapter 9The European Medicines Agency
Registration Procedures in the EU
EudraVigilance — The EU Safety Database
What Is Not in the Scope of EMA?
The Pharmacovigilance Risk Assessment Committee
Post-marketing PV EU Regulation
European Network of Centers for Pharmacoepidemiology and Pharmacovigilance
Agence Nationale de Sécurité des Médicaments et Produits de santé
Chapter 10The EU Qualified Person for Pharmacovigilance
Frequent QPPV Inspection Findings by the EMA
Chapter 11The Uppsala Monitoring Centre
WHO Programme for International Drug Monitoring
Chapter 12Council for International Organizations of Medical Sciences