GCP Directions: Virtual Engagement for Clinical Compliance and Quality Professionals
GCP Directions—the leading clinical compliance and quality conference—returns in July 2026. The 2025 event brought together senior clinical research, compliance, and quality professionals from across the industry for three days of virtual learning, networking, and forward-looking conversations. Designed specifically for trial sponsors, GCP Directions delivered actionable insights on how to navigate the evolving landscape under ICH E6(R3) and beyond.
Highlights from GCP Directions 2025
Focused Audience: A sponsor-driven forum with more than 500 attendees, the majority representing pharma, biotech, and device organizations.
- Experienced Audience: This wasn’t a beginner crowd—65% had over a decade in clinical research, and nearly one-third had 20+ years under their belt.
Core Themes: Each of the four days focused on a topic theme. Click here to access the detailed agenda.
- Monday—Regulatory Updates
- Tuesday —Operational Alignment
- Wednesday—Inspection Readiness
- Thursday—Future-Ready Compliance
Interactive Formats: In addition to standard presentations and panels, participants took part in intimate interactive sessions—not recorded to encourage candid sharing.
New connections were forged through 1:1 matching
Every question found an answer in an Ask Me Anything with Donna Dorozinsky
We got the inside scoop during an Inspection Gossip session
Participants chose from focused discussions such as:
• Whose Interpreting R3 at Your Company?
• TMF Therapy
• Oversight or Overkill
• Whose Process Is It Anyway?
• QbD or Buzzword?
• That Seemed Like a Good Idea But…
Each was designed to spark practical dialogue, surface lessons learned, and share real-world experiences.
Forward Momentum: From the finalized ICH E6(R3) guideline to the development of the V4 TMF Reference Model, attendees gained clarity on what matters most for compliance and quality today and tomorrow. As the GCP Directions clinical compliance and quality conference continues to grow, participants gained clarity on what matters most for sponsors today and tomorrow.”
Why the GCP Directions Clinical Compliance and Quality Conference Matters
The clinical compliance and quality environment is only becoming more complex. GCP Directions has established itself as the place where sponsors and quality leaders learn how to:
Align processes with R3 expectations
Strengthen trial oversight across people, process, and systems
Build inspection-ready confidence
Exchange real-world lessons with peers
By combining regulatory expertise with sponsor-to-sponsor discussion, GCP Directions provides unmatched value for clinical operations, compliance, and quality teams.
Looking Ahead: GCP Directions Clinical Compliance and Quality Conference 2026
Planning is already underway for GCP Directions 2026, taking place in July 2026. Attendees can expect:
Deeper dives into AI-enabled TMF oversight and data governance
Expanded networking opportunities tailored for trial sponsors
Case studies highlighting inspection readiness under R3
Even more interactive sessions to exchange strategies and solutions
