Regulatory scientists often support a single drug program for 10 years or more, navigating evolving guidances, shifting health authority expectations, organizational transitions, and increasing scrutiny. Over time, maintaining consistency of regulatory strategy, scientific rationale, and documentation becomes increasingly challenging. Critical knowledge is scattered across documents, systems, and teams, while manual workflows and reactive planning drive rework, delays, and regulatory risk.
This webinar is designed for regulatory scientists who are looking for practical ways to work more efficiently without compromising rigor or scientific judgment. It introduces RegKey, an end-to-end regulatory intelligence platform born from firsthand regulatory experience and extensive interviews with regulatory professionals to understand their real-world pain points. The platform is built with input from 50+ senior regulatory leaders, former FDA reviewers, and AI/ML experts, ensuring alignment with how regulatory science is actually practiced.
During the session, we will show how agentic AI—combined with curated regulatory data and expert-in-the-loop oversight—can support day-to-day regulatory work, including guidance interpretation, precedent analysis, FDA meeting preparation, and regulatory document authoring. Attendees will see how workflows that traditionally take months can be completed in days while preserving traceability, consistency, and submission-grade quality.
Participants will leave with concrete examples, lessons learned, and a framework for applying AI responsibly to regulatory science—helping teams reduce manual effort by 80–90%, maintain continuity across long development timelines, and engage with health authorities more confidently. Ultimately, this approach supports earlier patient access to life-saving therapies while strengthening regulatory confidence and scientific integrity.
What you’ll learn
- How to apply agentic AI with expert oversight to reduce manual regulatory effort while maintaining scientific rigor and submission-grade quality
- How to preserve consistency and institutional knowledge across a 10+ year drug lifecycle as guidances, teams, and expectations evolve
- How regulatory scientists can use real-time regulatory intelligence, demonstrated through a live use case demo, to improve FDA meeting preparation and regulatory documentation
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected]
Speaker
Somdip Datta
Aruna Dontabhaktuni
