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Pharmacovigilance

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Start Date: 2014-12-01
End Date: 2014-12-03
Time: 9:00 am to 5:00 pm

Phone: 01483 730071

Location: Rembrandt Hotel, 11 Thurlow Place, London SW7 2RS, United Kingdom

Website

Description

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

Registration Information

http://atnd.it/17089-1

Price
Standard: GBP 1750

Organizers

Organized by :  Management Forum Ltd

About the Organizers :