Free Live Webinar
AI in Clinical Trials: What FDA and EMA Now Expect
The regulators have set the framework. Our panel maps what it means for QA, data management, and GCP oversight.
What you'll take away
- A working read on the joint FDA and EMA principles, and what they expect of sponsors
- How context of use and credibility evidence apply to AI inside clinical systems
- Where GCP oversight now sits when a model touches trial data
- The questions to ask before your team puts AI anywhere near a trial
Save your seat
Free to attend. Can't join live? Register and we'll send the recording.
AI in Clinical Trials - Webinar - Aug 6, 2026
Our Partners
Sponsored By
Clinical Excellence GmbH is a clinical research consulting and training company specializing in GCP-compliant clinical trial operations.
The panel
Who you'll hear from.
A panel of practitioners who live inside these questions, moderated live with audience Q&A.
Moderator
Jessica Cordes
Senior Consultant
Clinical Excellence
Panelist
Saubiya Kidwai
Vice President of Quality
Signant Health
Why now
The regulatory footing finally exists.
On January 14, 2026, the FDA and EMA jointly issued ten guiding principles for good AI practice across the drug development lifecycle. FDA's draft guidance on the use of AI in regulatory decision making is moving toward final.
For the first time there is a shared, risk based framework for putting AI to work in clinical trials, and with it a shared expectation that sponsors can defend how they did it.
Meanwhile, AI is already in the trial. It is resolving queries, screening patients, ranking sites, and drafting narratives. The tooling has moved faster than the governance, and the people accountable for quality and GCP oversight are being asked questions they do not yet have documented answers to.
Built for
Who should attend.
Built for the people accountable when AI touches a trial, across quality, data, operations, and regulatory.
Clinical Quality Assurance
GCP Compliance
GCP Auditors
Regulatory Affairs
Clinical Operations
Clinical Data Management
CSV / CSA
IT Quality
Clinical Systems
The series
Part of AI in Clinical Operations & Clinical Trials.
Six live panels on where artificial intelligence is reshaping clinical trials. Free to attend, and every session recorded.
1
AI in Clinical Trials: What FDA and EMA Now ExpectNext up
Aug 6, 2026
2
Validating AI and ML in Clinical Systems: Extending CSA to GCP
Sep 10, 2026
3
AI in Clinical Data Management: Automation, Reconciliation, and Data Integrity
Oct 27, 2026
4
AI Driven Patient Recruitment and Site Selection
Nov 12, 2026
5
Centralized and Risk Based Monitoring with AI
Dec 3, 2026
6
Generative AI for Protocols, CSRs, and Regulatory Narratives
Jan 14, 2027
