Press Release
ROME, Italy – June 18, 2026
Clinical trials continue to place heavy demands on quality assurance teams, with protocol design, informed consent, data integrity, oversight and inspection readiness among the areas where mistakes can affect trial conduct. As trials move across sponsors, sites, vendors and digital systems, GCP compliance depends on how well decisions, documentation and responsibilities hold together from start to finish.
Advanced GCP in Action: Real-World Insights from Audits & Inspections, taking place online on 1 & 2 October 2026, has been developed around those practical pressure points. The live training follows the clinical trial lifecycle from protocol development and informed consent to regulatory and ethics submissions, vendor qualification, contracts, IT systems access, randomisation, unblinding, trial master file and site master file management.
The course is led by Katarina Thor, Independent Principal GCP Consultant and Former EMA/MPA-GCP Inspector.
The agenda includes a case-study workshop on protocol development, informed consent and site selection. It then moves into amendments and substantial modifications, sponsor oversight, investigator oversight, monitoring models, eTMF, EDC, eCOA and EMR systems, serious breaches and IMP lifecycle management.
The second day focuses on closing the trial, including data cleaning, database lock, clinical study report development and archiving. It also covers clinical audits versus inspections, inspection triggers and selection, mock inspection readiness, inspection announcements, execution, outcomes, follow-up actions and shared lessons from real-world audit and inspection situations.
