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How Can International Guidances Enable Global Regulatory Convergence?
Session Chair(s)
Mark Rosolowsky, PhD
Vice President, Global Regulatory Sciences, CMC
Bristol-Myers Squibb Company, United States
This session will focus on how international organizations such as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), International Medical Device Regulators Forum (IMDRF) and International Coalition of Medicines Regulatory Authorities (ICMRA) enable global regulatory convergence in particular for quality topics. The impact of some recent quality guidances on impurities (e.g., ICH M 7 and ICH Q3D) will be discussed in detail.
Learning Objective : Describe the goals and evolution of international organizations such as International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); Discuss regulatory expectations for important quality attributes.
Speaker(s)
Trends in Global Regulatory Convergence: ICH, IMDRF and ICMRA
Toshiyoshi Tominaga, PhD
SunFlare Co., Ltd, Japan
Life Science Department, Advisor
Control of Genotoxic Impurities: Is ICH M7 a Paradigm Shift?
Ramani Raghavan, MS, MSc
Genentech, A Member of the Roche Group, United States
Senior Regulatory Program Director
Elemental Impurities: Approaches for Conducting Product Assessments
Mark G. Schweitzer, PhD
Novartis Pharmaceuticals Corporation, United States
Global Head, Analytical Science and Technology