Outsourcing AI Solutions in Clinical Development: Legal and Compliance Essentials

Booking Link: click here to book

Description of event:

More and more of the AI solutions used in clinical development are bought from vendors rather than built in-house. For outsourcing and vendor managers, that means AI now sits inside the contracts and oversight models you already run, and it brings questions that standard CRO and vendor agreements were not written for. Is the AI system regulated by the EU AI Act and, if so, who is responsible for the system? What happens to the data it is trained on and the data it produces? Who carries the risk if it gets it wrong?

In this one-hour session, three speakers will set out the legal and compliance essentials of outsourcing an AI solution, using the procurement of digital twin technology as a practical example to show how each issue plays out in a real sourcing decision.

What we will cover:

• How the EU AI Act and GDPR apply when you buy, rather than build, an AI solution
• Contract points to negotiate: liability, warranties, indemnities, audit rights and data provenance
• How to assess the risk of an AI system and what that triggers
• Vendor due diligence: what to ask before you sign
• Oversight after signature: monitoring, change control and documentation
• Digital twins as a worked example, from vendor selection to ongoing oversight
• A practical checklist you can take back to your team

Who should attend: outsourcing, vendor and alliance managers, procurement, clinical operations, and legal and compliance professionals in pharma, biotech and CROs.

Speakers

Joshua Gray	Sarah Cowlishaw	Olena Goloborodko
Technology Partner, Covington	Life Science Partner, Covington	AI governance and data privacy advisor (AIGP, CIPP/E)

The session is for general information and does not constitute legal advice.