Past Event
日にち
June 16-20, 2024
Location
San Diego, CA
Booth #2319
DIA Annual Meeting 2024
Sessions by Certara:
Monday, June 17 4:45-5:15pm
Certara Innovation Theater: Technology-Enabled Writing – Use CoAuthor™ as your Fully Integrated GenAI Medical Writing Platform
Dr. Christopher Bouton, Senior Vice President and Head of A.I
Demetrius Carter, Senior Vice President, Regulatory Services
CoAuthor™ is the ultimate solution for fast-tracking drug development timelines and improving efficiency in the content generation process. Our AI-powered authoring platform combines the capabilities of Structured Content Authoring and Generative Artificial Intelligence to automate repetitive tasks and streamline the content generation process. With CoAuthor, writers can integrate data directly into documents, ensuring consistency and traceability while using a GenAI assistant to accelerate content generation from complex data inputs. The latest enhancements include the ability to create custom document templates and the application of style guides, providing a seamless integrated experience using MS Word. CoAuthor is the ultimate companion tool that can help you achieve your goals with ease and confidence. Trust in CoAuthor to improve your document quality, increase efficiency, and adhere to industry best practices and lean authoring techniques.
Tuesday, June 18th | 10:00am-11:00am
#225: Regulatory Guidance and Papers on Technology Innovations
Session Chair: David Meats, Director, Regulatory Services Management, Certara
Session Speakers:
AI and Technology Trends and Regulation Introduction
David Meats, Director, Regulatory Services Management, Certara
Regulation Guidance and Concensus Papers
Madhavi Gidh-Jain, PhD, Global Medical Writing and Document Management Head, Sanofi, United States
Regulation Guidance
Louise Lind Skov, PhD, Head of Content Digitalisation, Novo Nordisk A/S, Denmark
Monday, June 17 to Wednesday, June 17
参加登録はこちら
Demos by Certara
CoAuthor: 生成AIによる薬事規制文書作成プラットフォーム
Today’s regulatory writing technology needs to get smarter, while remaining user-friendly and collaborative. With CoAuthor, it has. CoAuthor expedites the writing process by bringing three capabilities into the Microsoft Word UI: fast template selection, structured content authoring, and generative AI.
- 275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 any or all of 9 health authorities’ required structure, XML, and validation report.
- Review eCTD submissions across stakeholders prior to submitting
