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Update on ICH Safety Topics
Session Chair(s)
Andreas Hartmann, PhD
Executive Director
Novartis Pharma, Switzerland
Jan Willem van der Laan, PhD
Senior Assessor Pharmacology and Toxicology
Medicines Evaluation Board, Netherlands
Update on ICH safety topics
Speaker(s)
Introduction: Current ICH “S” topics and related initiatives
Andreas Hartmann, PhD
Novartis Pharma, Switzerland
Executive Director
S1 Carcinogenicity testing – nearby Step 2
Jan Willem van der Laan, PhD
Medicines Evaluation Board, Netherlands
Senior Assessor Pharmacology and Toxicology
S5 Reproduction Toxicity Testing – the final issues
Paul Barrow
Roche, Switzerland
Distinguished Scientist
S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines
Luc M De Schaepdrijver, DVM
Janssen R&D, Belgium
Scientific Director/Fellow Toxicology
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