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2024 年 eCTD v4.0 热门问题解答

网络研讨会

The rollout of eCTD v4.0 is accelerating. Timing for this industry-wide transition is no longer in the distant future but rather now. One health authority is already live, one is going live this year (2024), and multiple are planning to implement within the next year. Certara has hosted webinars on eCTD v4.0, held GlobalSubmit user workshops, and collaborated with health authorities on their technical pilots in order to keep you abreast of the latest updates. With questions on eCTD v4.0 pouring in, we have compiled the most burning questions for 2024. Join us as we reveal these top questions and provide answers.

演讲嘉宾
Trevor Standish
Trevor Standish
Product Director
Trevor Standish 是 Certara 产品总监,在制药、金融和营销等多个行业创建和实施创新软件产品方面拥有十多年的经验。他是一位以客户为中心的团队领导者,在产品 SDLC 管理、UI/UX 设计、人工智能/ML 系统和创新等多个领域拥有专业知识。Trevor 在管理软件开发生命周期、确定全球产品战略和路线图以及领导团队向敏捷方法过渡方面拥有丰富的经验。他曾在各种行业会议上发表演讲,协助全球销售团队,并在高管圆桌会议上发言。他曾在 Certara、Concentric、Synchrogenix 和 Fifth Third Bank Corp 等公司任职,展现了出色的领导能力,管理产品组合,并制定了战略性产品路线图。
Maryanne Loscalzo
Maryanne Loscalzo
Associate Director, Regulatory Operations
Maryanne 是一位成就卓著、以结果为导向的监管事务专业人士,擅长 eCTD 递交、FDA 互动和项目管理。她拥有20多年的工作经验,在向各种监管机构成功提交监管申请方面成绩斐然。
Somya pic 3
Somya Agarwal
Product Owner

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