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eCTD 4.0: FDA 递交材料的新标准 【亚太地区网络研讨会】

Thu, June 20th 2024
网络研讨会点播

Video Coming Soon

The world of electronic regulatory submissions is about to change with the introduction of eCTD (Electronic Common Technical Document) v4.0. This latest version of the standard includes updated specifications and guidelines for the preparation and submission of electronic regulatory documents.

During this webinar, we will cover the similarities and differences between the FDA’s eCTD v4.0 and previous versions, as well as the FDA’s current plans for rolling out this new standard. A brief demo of GlobalSubmit Publish will help show exactly how eCTD v4.0 will appear when preparing a submission using this new standard.

网络研讨会对谁最有帮助:

  • 制药和生物技术公司的监管运营团队
  • CROs that support regulatory submissions for FDA

网络研讨会的持续时间和时区:

  • 30 分钟包含问答
  • 网络研讨会将在亚太时区举行,中国为下午 2 点,日本和韩国为下午 3 点。

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