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SESSION 1: FUNDAMENTALS
Session Chair(s)
Michael Forstner, PhD, MPH, MSc
Head of Global Safety Science
SOBI, 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, Czech Republic
CEO
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