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SESSION 7: MATHEMATICS OF DRUG SAFETY AND SAFETY RISK MANAGEMENT
Session Chair(s)
Michael Forstner, PHD, MPH, MSC
Managing Director, Head of Pharmacoepidemiology Practice
Mesa Laubela-Consulting, Switzerland
• Mathematics of Drug Safety
• Risk Assessment in Clinical Trial
• Development Risk Management Plan
• Links to EU-RMP, REMS, DSUR and PSUR
Speaker(s)
MATHEMATICS OF DRUG SAFETY AND SAFETY RISK MANAGEMENT
Jan Petracek, MD, MSC
iVigee Services a.s., Czech Republic
CEO
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