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Session Chair(s)
Klaus Olejniczak, DVM
Non-Clinical Regulatory Consultant, Germany
Speaker(s)
Introduction to the ICH Topic M7 and Q3D
Klaus Olejniczak, DVM
Non-Clinical Regulatory Consultant, Germany
The ICH Guideline on Mutagenic Impurities in Drugs – Current status, options and issues for drug development
Lutz Mueller, PHD
F. Hoffmann-La Roche Ltd., Switzerland
Lead Late Stage Projects - Toxicology
ICH S10 - Photosafety: Preclinical Safety Harmonisation Topics Currently at Step 2
Ulla Wändel Liminga, DrMed, MS, RPH
Medical Products Agency (MPA), Sweden
Scientific Director Pharmacology/Toxicology