Pharmacovigilance
December 1 - 3, 2014 - Rembrandt Hotel, 11 Thurlow Place, London SW7 2RS UKManagement Forum Ltd
sarah@management-forum.co.uk
Phone:01483 730071
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