DIA 全球年会 2022

无论您是监管递交流程的老手还是新手，都不能轻视电子通用技术文档 (eCTD) 提交被拒的风险，尤其是考虑到监管环境的不断变化和日益复杂。更不用说各地区 eCTD 提交标准的差异、整个文档生命周期的管理，以及实现企业加快产品上市的目标。有了 Certara GlobalSubmit™ eCTD 申报管理软件，您就可以为监管团队提供高效发布、验证和审查 eCTD 提交文件所需的工具。这意味着您可以通过简化的 eCTD 提交流程来消除风险并避免不必要的步骤，从而为您的监管团队提供支持，帮助他们赶在截止日期前向患者提供治疗。

Certara’s Synchrogenix™ Writer is designed specifically to assist your medical writers in creating patient safety narratives through an easy-to-use interface that streamlines writing deliverables through automation, reusability, and advanced technology. Unlike traditional methods of manually writing patient narratives, the cloud-hosted and validated regulatory software ensures consistency and quality, as well as decreased production times and costs.

Pinnacle 21 Enterprise 5.1.0 offers immense value to experts in biostatistics and biometrics, and clinical and statistical programming. Pinnacle 21 Enterprise validates data quality and compliance with Clinical Data Interchange Standards Consortium (CDISC) standards, enabling a clean data pipeline from worldwide sponsors to health authorities. Pinnacle 21 Enterprise customers include 22 of the top 25 biopharmaceutical companies by R&D spend, as well as the US FDA and Japan’s Pharmaceutical and Medical Devices Agency.

Exhibit Hall Theater #1 Narratives are a key component of clinical study reporting. To present a concise & medically relevant patient story, writers must analyze large volumes of data for patients. Implementing technology will ensure quality, consistency, and decreased turn-around times. We will discuss the automated approach to work through complex sources to produce streamlined narratives for submission. Greater efficiencies will empower writers to focus on critical thinking, a quality which remains unique to humans. Register here: https://sched.co/yPF2

为市场准入、医学事务和销售现场团队开发交互式且易用的利益相关者参与内容是一个耗时、昂贵且通常分散的过程。BaseCase 是一个“无代码”平台，使您能够可视化大型复杂数据集和经济模型，向关键决策者清楚地展示您的产品价值。

Given the launch of Project Optimus, how do you best navigate the evolving regulatory landscape and determine the optimal way to engage with the agency? Join this special event at DIA 2022 to address key questions that will help you to create a plan that’s tailored to your needs, whether you are at pre-IND stage or already in the clinical phases. 地点Prairie Room located on the 2nd floor of the Hyatt Conference Center Register here: https://www.certara.com/webinar/project-optimus-how-to-engage-with-the-fda-to-advance-your-program/

This is a hybrid delivery (in person and virtual). Recognize how using efficient writing processes will save time and improve the quality of the documents generated; Identify key considerations for planning simultaneous multi-region marketing applications; Describe the potential for a structured content authoring software platform to enhance preparation of summary documents. Register here: https://sched.co/vWNj