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SESSION 5: AGGREGATE REPORTING
Session Chair(s)
Michael Forstner, PhD, MPH, MSc
Head of Global Safety Science
SOBI, Switzerland
• Development Safety Update Report (ICH E2F)
• Regional - EU Annual Safety Report and US IND Annual Report
• Clinical Study Reports, ICH E3 & Lab Data
Speaker(s)
AGGREGATE REPORTING
Jan Petracek, MD, MSc
Ivigee, Czech Republic
CEO
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