Pharmacovigilance
Course
In The Rembrandt Hotel, London
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Indian Biological-science and Research Institute
Course Online£ 290 -
Indian Biological-science and Research Institute
Course Online£ 338
Description
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Type
Practical seminar
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Level
Beginner
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Location
The rembrandt hotel, london
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Class hours
8h
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Duration
3 Days
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in Drug safety.
KEY TOPICS TO BE ADDRESSED AT THE PHARMACOVIGILANCE 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 and DSURs * Pro-active Pharmacovigilance Pre- and Post Marketing
Clinical Trial ADR reporting requirements
Risk/Benefit Assessment
Drug Surveillance in countries outside Europe
Examples of pharmacoepidemiological studies used in risk management
Introduction to Signal detection
Introduction to Risk Management plans
Practical Pharmacovigilance Workshop
Facilities
Location
Start date
Start date
About this course
This 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.
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.
Reviews
Subjects
- Surveillance
- Risk
- Risk Management
- Marketing
- ADR
- Global
- Clinical Trial
- IT risk
- Management of Risk
- Regulations
Teachers and trainers (5)
Carol Markwell
Drug Safety Solutions Ltd
Dr Bill Richardson
Medical Advisor at NDA
Dr Glyn Belcher
Senior Director of Drug Safety & Risk Management, Biogen Idec Ltd.
Dr Ian Douglas
Lecturer in Pharmacoepidemiology at London School of Hygiene
Dr John Parkinson
Head of General Practice Research Database – MHRA
Course programme
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in Drug safety.
KEY TOPICS TO BE ADDRESSED AT THE PHARMACOVIGILANCECONFERENCE
- 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 and DSURs * Pro-active Pharmacovigilance Pre- and Post Marketing
- Clinical Trial ADR reporting requirements
- Risk/Benefit Assessment
- Drug Surveillance in countries outside Europe
- Examples of pharmacoepidemiological studies used in risk management
- Introduction to Signal detection
- Introduction to Risk Management plans
- Practical Pharmacovigilance Workshop
This 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.
Additional information
Pharmacovigilance
-
Indian Biological-science and Research Institute
Course Online£ 290 -
Indian Biological-science and Research Institute
Course Online£ 338