CREATE on AI for Regulatory Affairs + Live from Rome with Team PRRC скачать в хорошем качестве

CREATE on AI for Regulatory Affairs + Live from Rome with Team PRRC

In this session, Dina Lakayan, Founder and Regulatory Affairs Consultant at CREATE, and Maarten ter Mors, Chief Technology Officer at CREATE, discuss how artificial intelligence is transforming regulatory affairs—from documentation automation to intelligent compliance tracking. Joining live from Rome, the Team PRRC shares insights from recent EU regulatory meetings, including updates on proposed MDR changes and AI integration in post-market surveillance. Together, they unpack how MedTech professionals can adopt digital-first approaches to regulatory strategy and maintain “state of the art” compliance in a rapidly evolving environment. This session highlights: • How AI is being applied to automate regulatory documentation. • Insights from Rome on upcoming MDR and AI regulation updates. • Best practices for digital workflows in compliance management. • Early takeaways from CREATE’s AI-driven regulatory projects. • The PRRC perspective: what’s next for EU compliance teams. Who should watch? If you’re in Regulatory Affairs, Quality, or MedTech Strategy, this discussion provides: ✅ Real-world use cases for AI in regulatory work ✅ Expert commentary on MDR’s future direction ✅ Practical next steps for preparing your organization for AI-enabled compliance ⏱️ Chapters (00:00) – Getting started (00:01) – Announcements and live setup (00:05) – Live from Rome: Team PRRC updates (00:07) – MDR proposed changes from the EU Commission (00:13) – Anticipation around new regulatory guidance (00:17) – What’s next for PRRC teams (00:22) – Overview of CREATE’s AI platform for regulatory affairs (00:29) – AI in document management and submissions (00:35) – Lessons from implementing AI tools (00:42) – How AI impacts RA/QA workflows (00:48) – Q&A and closing thoughts 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.