AI for Regulatory Affairs: Unlocking Insights from Unstructured Data скачать в хорошем качестве

AI for Regulatory Affairs: Unlocking Insights from Unstructured Data

How much regulatory intelligence is buried in PDFs, submission history, and technical documentation and how fast could you move if it were instantly accessible? In this Friday In-Focus session, Michelle Wu (NyquistAI) shows how AI-driven document intelligence helps MedTech teams extract facts, trends, and risks from unstructured content to make faster, smarter regulatory decisions. You’ll see • NyquistAI’s approach to document intelligence and RA workflows. • High-value RA use cases (submission prep, labeling changes, PMS, change control). • Implementation lessons: adoption, accuracy, validation, and governance. • Security & privacy guardrails for regulated environments. • ROI & speed-to-decision benchmarks from real deployments. • Open Q&A with live audience questions. Who should watch: Regulatory Affairs, Quality, Clinical, and Product leaders exploring or scaling AI for compliance. ⏱️ Chapters (00:15) – Welcome & housekeeping (01:57) – Today’s topic & guest intro: Michelle Wu (NyquistAI) (02:51) – High-value RA workflows to automate with AI (02:55) – NyquistAI’s document-intelligence approach (18:23) – Audience questions start (live Q&A begins) (19:54) – Data sources: PDFs, submissions & technical files (31:36) – Validation expectations (traceability, accuracy, GxP) (44:59) – Security & privacy considerations (54:26) – ROI and speed-to-decision: what teams are seeing (1:00:52) – Use cases & success stories (1:10:10) – Closing & resources About Friday In-Focus Friday In-Focus is MLVx’s weekly webinar series—always free, always interactive—spotlighting MedTech’s most experienced thinkers and doers. 👉 Join the MLVx community: https://members.mlvexchange.com 🎟️ Use code SEAN20 to save 20% on membership.