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Developing a Regulatory CMC Strategy for Global Markets, with an Emphasis on ICH Guidance
Manage episode 445290875 series 3603634
Contenido proporcionado por Despina & Ethan at Enkrisi and Ethan at Enkrisi. Todo el contenido del podcast, incluidos episodios, gráficos y descripciones de podcast, lo carga y proporciona directamente Despina & Ethan at Enkrisi and Ethan at Enkrisi o su socio de plataforma de podcast. Si cree que alguien está utilizando su trabajo protegido por derechos de autor sin su permiso, puede seguir el proceso descrito aquí https://es.player.fm/legal.
In this podcast, Desi and Ethan discuss the importance of a robust Global CMC regulatory strategy for pharmaceutical companies seeking global market access. It emphasizes the need to understand the regulatory requirements of each target market, harmonize CMC data and documentation across regions, and establish a comprehensive quality system. The article also highlights the role of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in harmonizing regulatory requirements and supporting a cohesive approach to CMC globally.
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