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UKConference

Pharmacovigilance


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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.

Details

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

WHY YOU SHOULD ATTEND

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.

Prices

TBC

Contact

Leigh White
info@management-forum.co.uk

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