ok QbD理念深析：色譜技術與風險評估在分析開發中的應用-國際制藥項目管理協會（IPPM）-蒲公英 - 制药技术的传播者 GMP理论的实践者

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蒲公英 - 制药技术的传播者 GMP理论的实践者»蒲公英論壇 › 教育＆平台 › 國際制藥項目管理協會（IPPM） › QbD理念深析：色譜技術與風險評估在分析開發中的應用

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[課程會議] QbD理念深析：色譜技術與風險評估在分析開發中的應用

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发表于 2025-2-18 09:55:36 | 只看該作者 |只看大圖回帖奖励

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前言

新药的安全性与有效性的验证及获取上市许可的核心关键在于药品注冊申报。鉴于医药行业日新月异的发展态势及监管部门对药品质量标准的持续提升，质量研究在药品注冊过程中占据了重要地位。

“药品注冊申报中的质量研系列课程旨在构建一套详尽且条理清晰的质量研究指导体系，从辅助药品研发、注冊及质量控制团队，深化对质量研究基本原理等关键点出发，促使药品的研发与注冊流程严格遵循既定的法律规章与质量标准，为公众用药的安全性与有效性提供坚实保障。

本課程專注于QbD理念的分析方法開發與案例解析，旨在幫助學員深入理解QbD概念與分析方法開發的風險評估。由上海臨港産業大學生物醫藥學院藥物分析專業分院明捷醫藥與蒲公英教育聯合主辦，特邀迪哲醫藥CMCRA副總監曾文亮博士進行授課。

課程將深入剖析QbD理念，全面介紹色譜參數及色譜柱知識，並著重講解分析方法開發中的風險評估技巧。此外，課程還將通過解析分析方法開發的一般流程與具體案例，幫助學員更好地理解和掌握相關技能。

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医药及生物技术行业研发、注冊、质量、法规及相关领域的管理及技术人员。

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本主題由 System 于 2025-2-25 17:00 解除限时高亮

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