Pharmacovigilance - Management Forum
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| Pharmacovigilance - Management Forum | |
|---|---|
| Date | 19-21 Jun 2018 & 3-5 Dec 2018 |
| Place | London, UK |
Understanding PhV today a training course for those working on drug safety monitoring in the EU, USA and Japan
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, 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.
Key topics to be addressed at this 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
Contents
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Key topics to be addressed at this 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
Speakers
- Carol MarkwellDrug Safety Solutions Ltd, UKFind out more
- Dr Bill RichardsonMedical Advisor at NDAFind out more
- Dr Glyn BelcherConsultant, PV Consultancy LtdFind out more
- Dr Ian DouglasLecturer in Pharmacoepidemiology at London School of Hygiene & Tropical MedicineFind out more
- Dr John ParkinsonConsultant Expert in Data and PharmacoepidemiologyFind out more
- Dr John TalbotSenior Lecturer at University of HertfordshireFind out more
- Professor Saad ShakirDirector, Drug Safety Research UnitFind out more
- Shelley GandhiDirector, Pharmacovigilance & Drug Safety, NDA Regulatory Science Ltd
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