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Conference: DIA Europe 2026

開催日: March 24 - 26, 2026

開催場所: Rotterdam, Netherlands

Booth: E5

Visit Certara in Booth E5 at the DIA Europe 2026 in The Netherlands | March 24-26, 2026

サターラはライフサイエンス業界のイノベーターと連携することで、患者さんに医療を迅速に届けます。Together we advance modern drug development with biosimulation, regulatory science, and market access solutions. We use software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries.

CoAuthor

Regulatory writing technology needs to be smarter, user-friendly, and collaborative—and CoAuthor delivers. It streamlines the process with fast template selection, structured content authoring, and generative AI within Microsoft Word.

  • 280以上のeCTD準拠テンプレートにスタイルガイドを適用することで、文書のフォーマットに費やす時間を50%削減できます。
  • 複合語から作用機序に関する段落まで、あらゆる文章をすべてのドキュメントで再利用できます。
  • Leverage a biomedically-specialized GPT behind your firewall, for secure, prompt-based text generation

GlobalSubmit eCTD Platform

GlobalSubmit enables teams to manage the regulatory process so they can successfully publish, validate, and review eCTD submissions across a global footprint of regulatory health authorities.

  • Create submissions that conform to health authorities’ required structure, XML, and validation report, including eCTD 4.0.
  • Identify and resolve compliance issues before submission, reducing rejection risks with a robust validation engine.
  • Streamlined Review Process across stakeholders with advanced navigation and annotation features.

Where to hear Certara insights and expertise

Thursday, March 26 | 11:45 - 12:15pm
Best Practices for Simultaneous Submissions to EMA/FDA

講師: Tinka Tuinstra

開催場所: Dock 16, Session Room 8

Sponsor companies are now expected to submit globally as quickly as possible. Successful achievement of this combination of speed and complexity requires extensive regulatory knowledge and planning. The first half of this presentation will cover how to plan for simultaneous global submissions, including aspects the team can control and aspects that are out of the team’s control. The second half of this presentation will cover the strategic planning and practices necessary for efficiently publishing and assembling the thousands of documents and data files required for submission.

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