AI is rapidly finding its way into pharmaceutical, biotechnology, medical device, clinical research, and other regulated environments. But introducing AI into a GxP environment creates a unique governance challenge: how do we balance innovation with patient safety, data integrity, regulatory compliance, and accountability?
In this session, we will explore what responsible AI governance looks like in a GxP-regulated environment and why traditional AI governance approaches may not be enough. We will look at practical considerations around AI risk, validation, data integrity, human oversight, transparency, accountability, change management, and third-party AI systems.
The session will also explore how emerging AI regulations and standards, including the EU AI Act and ISO/IEC 42001, can complement existing GxP quality and regulatory frameworks.
The goal is to provide a practical governance perspective that helps regulatory, quality, compliance, and technology professionals ask the right questions before deploying and scaling AI in regulated environments.
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].
To reach out to Australia LNG directly with questions:
Email: [email protected]
Speaker
Dr. Latha Karthigaa
