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