Pharmacovigilance

Pharmacovigilance is a course that addresses regulatory developments in pharmacovigilance in Europe, the USA, and Japan.

Pharmacovigilance covers topics such as:

  • Risk Management and the development of the Pharmacovigilance plan
  • Principles of Pharmacovigilance and Data Resources
  • Pharmacoepidemiology Studies
  • Causality Assessment: Clinical Diagnosis of Adverse Events
  • Pro-active Pharmacovigilance Pre- and Post Marketing
  • Evolution of PSURs, PBRERs and DSURs
  • Risk/Benefit Analysis
  • Pharmacovigilance Regulations (clinical trials & post marketing) including new EU Pharmacovigilance
  • Post-marketing Surveillance: Observational Cohort Studios
  • Drug Surveillance in countries outside Europe
  • Introduction to Risk Management plans
  • Introduction to Signal detection
  • Practical Pharmacovigilance Workshop

Pharmacovigilance brings together Those Working On Drug Safety Monitoring and concerned with pharmacovigilance In The EU, USA And Japan including: personnel in adverse reaction monitoring units, R&D departments, registration departments and regulatory affairs as wel as drug safety officers and pharmaceutical physicians.

Future Events

Pharmacovigilance 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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