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AI Credibility in Life Sciences: FDA’s Regulatory Guidance
May 28, 2025 @ 12:00 pm – 1:00 pm EDT
Webcast overview
The life sciences industry is on the cusp of a transformative era, driven by the integration of Generative AI solutions. These advanced technologies are poised to revolutionize regulatory decision-making, ensuring the safety, effectiveness, and quality of life sciences products. However, with this innovation comes the need for clear and robust guidelines. The U.S. Food and Drug Administration (FDA) has recently published draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products”, to address the use of AI in regulatory processes.
Join us for an insightful webcast, co-hosted by KPMG and ValKit.ai, where we will delve into the implications and practical applications of this guidance.
Our Speakers:
Louie Rayal, VP of Governance, Risk & Compliance at GSK
Madhavi Ganesan, Life Sciences Director at KPMG LLP
Dr. Paul Campbell, Chief Regulatory Officer, HealthAI (Former MHRA)
Dr. Laura Rose, Engagement Partner, Bruder Consulting & Venture Group (Former FDA)
Stephen Robert Ferrell, Chief Product Officer, Valkit.ai
Continuing education
There will be 1.5 continuing professional education (CPE) credits available to participants who participate in the live webcast and meet the eligibility requirements. The webcast will last approximately 1.5 hours.
After registering for this event, you will receive webcast log‑in instructions (or dial in for audio‑only participation).
CPE credit is not available for viewing webcast replay.
