PR - Article - Advanced GCP in Action

Clinical trial compliance remains a critical priority for pharmaceutical, biotechnology and clinical research organizations as regulatory expectations continue to evolve. To address the practical challenges faced during audits and inspections, Advanced GCP in Action: Real-World Insights from Audits & Inspections will be held as an online live training course on 1–2 October 2026.

Led by Katarina Thor, Independent Principal GCP Consultant and Former EMA/MPA-GCP Inspector, the training provides practical guidance on Good Clinical Practice (GCP), clinical trial oversight, data integrity, sponsor and investigator responsibilities, risk-based monitoring, and inspection readiness. Participants will explore real-world case studies covering protocol development, informed consent, site selection, vendor qualification, eTMF management, electronic systems, serious breaches, and IMP lifecycle management.

The programme also focuses on clinical audits, regulatory inspections, mock inspection preparation, inspection outcomes, and lessons learned from actual inspection findings. Designed for clinical operations, quality assurance, regulatory affairs, and research professionals, the course offers actionable strategies to strengthen compliance, improve trial quality, and ensure inspection readiness throughout the clinical trial lifecycle.