Regulatory guidance for clinical trials shifts every quarter, often before trial teams notice. Florence Regulatory Pulse is a quarterly briefing for clinical operations, regulatory affairs, quality, and technology leaders who are responsible for keeping trials inspection ready.

Each session covers the most consequential regulatory developments globally, then gets specific: what to check in your current processes, where oversight gaps tend to open, and what to fix before your next inspection.

This quarter Sara Saunders, Director of Global Regulatory Affairs at Florence Healthcare and Kim Gallop, Senior Global Regulatory Analyst at Florence Healthcare, will walk through what’s changed and what it means for your study teams.

We’ll cover:

• China aligning its GCP requirements to ICH E6(R3), the latest step in global harmonization
• Health Canada and the UK moving from adopted regulation into practical implementation, including new trial registration and disclosure requirements
• FDA guidance reconsidering evidence standards and trial design requirements
• AI oversight moving from principles to enforcement, starting with FDA’s first AI-related warning letter and the EU AI Act
• Privacy regulators racing to keep pace with AI, from France’s CNIL update to ongoing EDPB work on anonymization

September 30 · 11am–12pm ET

Register now →