Pharmacovigilance - A Basic Training for those working on Drug Safety Monitoring in the EU, USA and Japan
10th December 2012 — 12th December 2012
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 the development of the Pharmacovigilance Plan
- Causality Assessment: Clinical Diagnosis of Adverse Events
- Pharmacoepidemiological Studies
- PSURs and the link with DSURs and the EU risk management plan
- Proactive Pharmacovigilance Pre- and Post Marketing
- Pharmacovigilance Regulations (clinical trials & post-marketing)
- Risk/Benefit Analysis
- Dug Surveillance in countires outside Europe
- Post-marketing Surveillance: Observational Cohort Studies
- Global pharmacovigilance regulations and systems and their link with EU pharmacovigilance
- Practical Pharmacovigilance Workshop
CHAIRMEN:
Dr. Barry Arnold, Qualified Person for Pharmacovigilance, AstraZeneca R&D, UK
Dr. Glyn Belcher, Consultant, PV Consultanty Ltd. .
Professor Saad Shakir, Director Drug Safety Research Unit, UK
SPEAKERS
Dr. Carol Markwell, Drug Safety Solutions Ltd, UK
Dr John Parkinson, Director, Clinical Practice Research Datalink - MHRA, UK
Dr John Talbot, Senior Lecturer at University of Hertfordshire
Dr Lynda Wilton, Research Fellow, Centre Paediatric Pharmacy Research, School of Pharmacy, University of London.
Speaker from MHRA to be confirmed
Expected Number of Attendees
0-50
View Conference Website: Pharmacovigilance - A Basic Training for those working on Drug Safety Monitoring in the EU, USA and Japan
Contact
Name: Leigh White
Email: info@management-forum.co.uk
Tel.: +44 (0) 1483 730071
URL: Website
Price of Attendance
£1675 + VAT
Brochure
Location
The Cavendish Hotel
81 Jermyn Street
London
United Kingdom
SW1Y 6JF