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
•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
