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Session 4: SAFETY AND QUALITY
Session Chair(s)
Steven Spanhaak, MSC
Scientific Director
Janssen Research & Development, Belgium
This session aims to provide information regarding a number of (evolving) ICH Safety and Quality guidelines. The presented spectrum ranges from more specific Safety (ICH S10, photosafety) and Quality (ICH Q7, GMP) topics to a clear area of overlap between Safety and Quality: impurity management (ICH Q3D, elemental impurities and ICH M7, DNA reactive impurities). Especially in the area of impurity management the last decade has provided a series of guidance documents to industry ranging from mutagenic impurities to metal catalysts. Although it is obvious that the common goal is to guarantee patient safety and quality of the products, the ever increasing challenge for industry and regulators is to strike a balance between perceived risks, (technical) capabilities and various guidelines.
Speaker(s)
S10 Photosafety Evaluation
Ulla Wändel Liminga, DrMed, MS, RPH
Medical Products Agency (MPA), Sweden
Scientific Director Pharmacology/Toxicology
M7 Assessment and Control of DNA Reactive Impurities in Pharmaceuticals
Steven Spanhaak, MSC
Janssen Research & Development, Belgium
Scientific Director
Q3D Elemental Impurities
Michael J. James, PHD, MSC
GlaxoSmithKline R&D, United Kingdom
Director of CMC Regulatory Advocacy and Intelligence
Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Stephan Roenninger, DRSC
Amgen (Europe) GmbH, Switzerland
Director, Quality Compliance External Affairs