Centre Hospitalier Luxembourg (CHL) Amphithéâtre 4, rue Barblé L-1210 Luxembourg
Ingrid Klingmann, MD, PhD: Chairman, European Forum for Good Clinical Practice (EFGCP)
Lisbeth Tofte, MD: Drug Safety Consult, Copenhagen, member of EFGCP
13:30-13:40 Welcome and Introduction
13:40-14:00 What is new in the ICH-GCP Guidelines with Integrated Addendum E6 (R2)? (Ingrid Klingmann)
14:00-14:45 Sponsor responsibility: Focus on quality management
14:45-15:15 Break
15:15-16:00 Practical aspects of a risk-based monitoring approach
16:00-17:00 Site management with validated computerized systems in Europe and US (CRF part 11)
17:00-17:30 Final test
17.30-17:45 Review and discussion of correct answers
17:45 Closing remarks
In the framework of the Luxclin conference, LIH CIEC organizes an interactive and certified training in “Good Clinical Practice”, focusing on updated ICH GCP guidelines (E6 R2 Update).
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