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Holiday Inn London Kensington Forum

Jan 26, 2016 8:30 AM - Jan 27, 2016 3:20 PM

97 Cromwell Road, London, SW7 4DN, United Kingdom

Pre-Marketing Clinical Safety

The course offers an overview of all the current major methodological approaches and hands-on solutions for day-to-day challenges.

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SESSION 1: FUNDAMENTALS

Session Chair(s)

Michael Forstner, PhD, MPH, MSc

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)

Jan Petracek, MD, MSc

FUNDAMENTALS

Jan Petracek, MD, MSc

Ivigee, Czech Republic

CEO

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