DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/4l8cpq/pharmacovigilance) has announced the addition of the "Pharmacovigilance - A Basic Training for Those Working on Drug Safety Monitoring in the EU, USA and Japan (Course, London)" conference to their offering.
The "Pharmacovigilance - A Basic Training for Those Working on Drug Safety Monitoring in the EU, USA and Japan" course will take place on 16-18th December 2013 at the The Rembrandt Hotel, London.
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
- Pro-active Pharmacovigilance Pre and Post Marketing
- Pharmacovigilance Regulations (clinical trials & post marketing) including new EU Pharmacovigilance Legislation
- Risk/Benefit Analysis
- Drug Surveillance in countries outside Europe
- Post-marketing Surveillance: Observational Cohort Studies
- Global pharmacovigilance regulations and systems and their link with EU pharmacovigilance
- Practical Pharmacovigilance Workshop
Day One:
Professor Saad Shakir, Director Drug Safety Research Unit, UK
Dr. Barry Arnold, EU Qualified Person for Pharmacovigilance, AstraZeneca R&D, UK
Day Two:
Dr. Barry Arnold, EU Qualified Person for Pharmacovigilance, AstraZeneca R&D, UK
Day Three:
Dr. Glyn Belcher, Consultant, PV Consultancy Ltd
WHY YOU SHOULD ATTEND
This Management Forum course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.
WHO SHOULD ATTEND
This three-day introductory course is aimed at personnel in research and development departments, adverse reaction monitoring units, regulatory affairs and registration departments; pharmaceutical physicians and drug safety officers. It will also be of direct benefit to all those who are involved and interested in the daily practice of pharmacovigilance.
ATTENDANCE LIMITED TO 40
This limitation, a unique feature of all MANAGEMENT FORUM seminars, will give participants the opportunity for a thorough discussion of the complex issues to be covered by the programme.
A Certificate of Attendance for Professional Development will be given to each participant who completes the course
For more information visit http://www.researchandmarkets.com/research/4l8cpq/pharmacovigilance.
