Pharmacovigilance 2019 is a course that covers topics such as:
- 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
Pharmacovigilance 2019 brings together attendees with responsibilities in:
- Adverse reaction monitoring
- Drug safety
- Regulatory affairs
- R&D
- Registration
