Pharmacovigilance 2019

Pharmacovigilance 2019 is a course that addresses regulatory developments in pharmacovigilance in Europe, the USA, and Japan.

Key Topics

• 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

Who should Attend

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.