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OVERVIEW OF CURRENT DISCUSSIONS IN ICH
Session Chair(s)
Klaus Olejniczak, DVM
Non-Clinical Regulatory Consultant, Germany
The major impacts of this session will be to enumerate acceptable levels and to describe potential approaches to the control of genotoxic and metal impurities in pharmaceuticals during development (clinical trials) and for marketing. The discussions will clarify when and how a genotoxic or a metal impurity should be identified and how it can be qualified and controlled.
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
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