Why Attend
What You'll Walk Away With
Practical knowledge you can apply to your organization immediately — not theory, not hype.
Regulatory Compliance Decoded
ICH E6(R3), FDA AI/ML guidance, 21 CFR Part 11, and the EU AI Act — explained in plain terms for clinical operations leaders.
eTMF Intelligence in Action
Live demonstration of AI-powered document automation aligned to CDISC TMF v3.3 — reducing classification time by 60%+.
Your 90-Day AI Roadmap
A structured governance and implementation framework with change management, vendor evaluation, and sequencing for immediate execution.
AI Readiness Assessment
Every registrant receives the AI Readiness Assessment tool, session recording, and complimentary strategy session access.
Agenda
60 Minutes. Five Segments. Zero Fluff.
Every minute delivers actionable insight grounded in real regulatory frameworks and live product demonstration.
Welcome & The Regulatory Moment
Why now: ICH E6(R3) is rewriting the rules. The EU AI Act is in force. FDA's AI/ML guidance is setting new expectations. The regulatory environment isn't a barrier — it's the roadmap.
Regulatory Compliance in the Age of AI
ICH E6(R3), FDA AI/ML guidance, 21 CFR Part 11, and the EU AI Act — decoded for clinical operations leaders. We'll examine what these frameworks require in plain terms, where organizations are exposed, and the practical compliance architecture that protects your pipeline.
eTMF Intelligence & AI-Powered Document Automation
How AI systems aligned to the DIA/CDISC TMF Reference Model v3.3 are transforming inspection readiness — reducing classification time by over 60% and flagging audit risks before inspectors do. Live demonstration of the Aurelyn eTMF Intelligence Engine workflow.
Building Your 90-Day AI Readiness Roadmap
A structured, actionable governance and implementation framework your organization can begin executing immediately. We cover change management, responsible AI policies, vendor evaluation criteria, and how to sequence AI adoption for maximum impact with minimum disruption.
Live Q&A with Sheilah Johnson-Rocha
Bring your most pressing questions. This session closes with an open, moderated Q&A. Attendees may also submit questions in advance upon registration. All registrants receive the session recording and a copy of the AI Readiness Assessment tool.
Regulatory Coverage
Grounded in the Frameworks That Govern Your Trials
Every recommendation is mapped to specific regulatory requirements — not theoretical guidance.
ICH GCP E6(R2) & E6(R3)
AI validation under GCP's quality management framework. Mapping AI-assisted decisions to investigator oversight obligations. What the R3 revision means for technology-enabled processes.
ICH E8(R1) & E9(R1)
Quality-by-design as the entry point for AI in trial design. Ensuring AI-driven endpoint selection aligns with pre-specified estimands for regulatory acceptance.
FDA GMLP & 21 CFR Part 11
The 10 GMLP principles applied to clinical operations. Audit trail requirements for AI-generated data. Part 11 compliance for automated data cleaning and decision support.
EMA Guidance & Annex 11
EMA's explainability expectations for AI-assisted submissions. Annex 11 validation for AI in clinical data management. Scientific advice for AI-driven trial designs.
EU AI Act, HIPAA & GDPR
Risk classification for clinical AI under Regulation 2024/1689. Conformity assessments and human oversight obligations. Data privacy implications for AI training data sourced from clinical trials across US and EU jurisdictions.
Audience
Who Should Attend
Designed for leaders evaluating, implementing, or governing AI in clinical research.
Clinical Operations Leaders
You need to accelerate timelines and reduce costs — without compromising GCP compliance or audit readiness.
CRO Executives
Your sponsors are asking about AI capabilities. You need differentiation — and the regulatory confidence to back it up.
Regulatory & Quality Leaders
You need to understand how FDA GMLP, ICH E6(R3), and the EU AI Act apply to the AI tools your teams are already piloting.
Clinical IT & Data Science
You're making build-vs-buy decisions on AI/ML and need a validation-ready roadmap that satisfies GAMP 5, CSV, and Annex 11.
Your Presenter
Meet Sheilah Johnson-Rocha
Sheilah Johnson-Rocha, MSc
Aurelyn AI
AI Strategy · Clinical Research Governance · Responsible AI
Sheilah brings deep expertise at the intersection of AI strategy and clinical research governance. Her work focuses on helping life sciences organizations — from mid-size CROs to global pharmaceutical sponsors — adopt AI responsibly, in full alignment with ICH GCP, FDA, EMA, and EU AI Act requirements. She is committed to ensuring that every AI initiative is grounded in regulatory compliance, organizational readiness, and measurable impact on patient outcomes.
Included
Every Registrant Receives
Complimentary materials included with your registration — no additional cost.
Clinical AI Readiness Assessment — a self-scoring diagnostic across data infrastructure, regulatory preparedness (ICH GCP, Part 11), team readiness, use-case prioritization, and governance maturity.
AI Regulatory Compliance Checklist — a one-page reference mapping governance requirements across ICH GCP, FDA GMLP, EMA Annex 11, EU AI Act, HIPAA, and GDPR.
Full webinar replay with searchable transcript and closed captions — available within 2 hours of the live event.
Priority access to book a complimentary 30-minute AI Strategy Session with the Aurelyn AI team — limited to 20 attendees.
Reserve Your Seat
Free to attend. Limited to 500 registrants. Live captions and typed Q&A enabled for full accessibility.
Register Now — FreeCan't attend live? Register to receive the replay, transcript, and all bonus materials.