根据EMA网站最近的一条新闻，EMA将采用数字应用程序数据集成 (DADI) 取代电子申请表，并将于CET（欧洲中部时间）1月18日10:30 - 12:00（即北京时间1月18日17:30 - 19:00）举行线上研讨会。研讨会链接如下，无需注册即可收看：
The Digital Application Dataset Integration (DADI) project will replace PDF electronic application forms (eAF) used for regulatory submissions with online forms, making the future form-filling and submission-handling process more efficient.
DADI is a European medicines regulatory network project that addresses eAFs for both centrally authorised products (CAPs) and nationally authorised products (NAPs). The new web-based forms will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the Fast Healthcare Interoperability Resources (FHIR) data standard.
The implementation of these new forms supports the EU requirement to integrate ISO IDMP (Identification of Medicinal Products) standards for human medicines.
This first public webinar is for stakeholders from the human & veterinary medicines industry and national competent authorities wishing to learn more about the following:
DADI roadmap & objectives for CAPS & NAPS
DADI’s connection to EMA’s Regulatory Business Optimisation
Main changes introduced by DADI and impacts for the pharmaceutical industry
The event will be broadcast live. A video recording will be made available after the event.
数字应用数据集集成 (DADI) 项目将用在线表格取代用于监管提交的 PDF 电子申请表 (eAF)，从而使未来的表格填写和提交处理过程更加高效。
DADI 是一个欧洲药品监管网络项目，旨在解决集中授权产品 (CAP) 和国家授权产品 (NAP) 的 eAF。新的基于网络的表格将使用快速医疗保健互操作性资源 (FHIR) 数据标准，与欧盟人类和兽药数据描述实施指南保持一致。
这些新表格的实施支持了欧盟整合人用药物 ISO IDMP（医药产品识别）标准的要求。
第一次公开网络研讨会面向希望了解以下内容的人用和兽药行业的利益相关者和国家主管部门：
DADI CAPS 和 NAPS 的路线图和目标
DADI 与 EMA 监管业务优化的联系
DADI 带来的主要变化及对制药行业的影响
该活动将进行现场直播。活动结束后将提供视频记录。
以下为研讨会的Agenda：
