Pharmacovigilance

A basic training for those working on Drug Safety monitoring in the EU, USA and JAPAN.

Key Topics To Be Addressed At This Conference: -

Principles of Pharmacovigilance and Data Resources
Risk Management and Risk Minimisation
Causality Assessment: Clinical Diagnosis of Adverse Events
PASS and PAES studies
Regulatory Framework
European Post-Marketing Pharmacovigilance Regulations
Pharmacoepidemiological Studies
Evolution of PSURs, PBRERs, DSURs
Pro-active Pharmacovigilance Pre- and Post-Marketing
Clinical Trial ADR reporting requirements
Risk/Benefit Analysis
Drug Surveillance in countries outside Europe
Post-marketing Surveillance: Observational Cohort Studies
Introduction to Signal detection
Introduction to Risk Management plans
Practical Pharmacovigilance Workshop

Speakers: Professor Saad Shakir Drug Safety Research Unit, Shelley Ghandi NDA Regulatory Science Ltd, Dr. John Talbot University of Hertfordshire, Dr. John Parkinson CPRD Consultant Expert, Dr. Glyn BelcherPV Consultancy Ltd