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In July 2021, the secretariat of the International Council for the Coordination of Technical Requirements for Human Drugs (hereinafter referred to as "ICH") decided to establish the guidance of "M14: General Principles on Planning and Designing Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of A Medicine" Informal Expert Working Group on Principles
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As the only member of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) that represents China's local pharmaceutical industry, the China Pharmaceutical Innovation Promotion Association has been screened internally and the two recommended experts have been successfully elected and will participate in the drafting, formulation and revision of the M14 guidelines And the implementation of the later landing conversion
Team Leader: Wang Cunlin, Vice President of Yasheng Pharmaceutical Safety and Pharmacovigilance
Expert: Guo Tong, Executive Vice President of ZeroKr Technology
In the future, the two experts will also represent the China Association for the Promotion of Pharmaceuticals and the Chinese pharmaceutical industry to speak out on the world stage, strengthen China's right to speak in international organizations, and promote the transformation and implementation of ICH guidelines in China