Pharmacovigilance 2019

Topics

• Risk management, causality assessment and PASS/PAES studies
• Principles of pharmacovigilance and data resources
• Proactive pharmacovigilance pre- and post-marketing, risk-benefit assessment
• Pharmacoepidemiological studies and evolution of PSURs, PBRERs and DSURs
• Post-marketing surveillance: observational cohort studies
• Pharmacovigilance regulations, clinical trial ADR reporting requirements n Drug surveillance in countries outside Europe
• An overview of signal detection and risk management plans

Who should Attend

Attendees with responsibilities in:

• Adverse reaction monitoring
• Drug safety
• Regulatory affairs
• R&D
• Registration