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SESSION 1: FUNDAMENTALS
Session Chair(s)
Michael Forstner, PHD, MPH, MSC
Managing Director, Head of Pharmacoepidemiology Practice
Mesa Laubela-Consulting, Switzerland
• The Concepts, Principles and Terminology
• CIOMS, ICH, ISO, Investigators Brochure, Informed Consent
• European Clinical Trial Directive
• European Guidelines (Volume 10 and 9A)
• Examples of National Implementation
Speaker(s)
FUNDAMENTALS
Jan Petracek, MD, MSC
iVigee Services a.s., Czech Republic
CEO
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