Sponsored in conjunction with the Regulatory Affairs Professionals Society (RAPS), featuring Tala Fakhouri, Vice President of Regulatory Consulting for AI & Digital Policy and Real-World Research at Parexel
Drug development teams are under increasing pressure to move faster—yet much of the regulatory process still depends on manual, document-heavy workflows.
In this webinar, Brandon Rice (CEO & Co-founder, Weave) and Tala Fakhouri (Regulatory Consultant, Parexel; former FDA AI policy lead) explore how a human-driven, AI-native approach is changing the way regulatory documentation is created, managed, and connected across the lifecycle—from IND through NDA and beyond.
Drawing on real-world examples from biotech, pharma, and CRO teams, the session highlights where AI is making a measurable impact today: reducing time spent on drafting and QC, improving collaboration across teams, and increasing predictability in document timelines.
Rather than focusing on tools alone, the discussion centers on how AI and human expertise work together—automating structured tasks while enabling regulatory and clinical teams to focus on interpretation, strategy, and decision-making.
The webinar also looks ahead to what’s next: extending these approaches across the full regulatory lifecycle, supporting global submissions, and using connected documentation to improve planning and reduce risk earlier in development.