Application
Risk-based monitoring principles using ICH GCP E6(R3), Critical-to-Quality factors, site-level risks, KRIs, and QTLs to focus monitoring on what matters most.
pharma
Clinical Monitoring MasterClass - EU edition
02-03 February, 2027
02-03 February, 2027Virtual
MasterClass in Pharma
The emphasis of the Masterclass is on doing the work, not simply learning definitions.
02-03 February, 2027, Virtual
Time Zone: UTC/GMT+1 /CET
Key learnings
Decision-Making
Make informed decisions on Source Data Review, SDV and central monitoring, based on risk, available evidence, and the purpose of the review.
Identify
Identify, assess and manage monitoring issues effectively, including protocol deviations, escalation, root cause analysis and development of sustainable CAPA.
Communication
Communicate findings clearly and effectively with investigators and site staff, distinguishing observations that require clarification, correction, escalation or further follow-up.
Recognition
Recognise monitoring red flags and evaluate inspection readiness, including whether TMF/ISF documentation provides clear evidence of compliant study conduct and oversight.
Translation
Translate the Monitoring Plan into practical monitoring decisions, including site prioritisation, visit planning and selection of the most appropriate monitoring approach.
Trusted by over 17,000 delegates across leading companies
Overview
The emphasis of the Masterclass is on doing the work, not simply learning definitions. Participants will practise interpreting a Study Protocol and Monitoring Plan, identifying monitoring signals, selecting appropriate monitoring activities, reviewing documentation, communicating with sites and completing follow-up records
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Meet the expert
Trainer
Agnieszka Sokol
Agnieszka Sokol is a GCP quality specialist, auditor and trainer with 20 years of experience in clinical research. She holds a PhD in molecular biology and has worked in both clinical operations and quality roles for CROs and pharmaceutical companies. Her experience includes inspection readiness, preparation, conduct and follow-up for FDA, EMA and local health authority inspections, as well as clinical trial audits. She supports teams in analysing findings, identifying root causes, developing CAPA plans and assessing the effectiveness of corrective actions. As a member of the GCPpl training group, she delivers practical training on audits, inspections and CAPA management.
Ernest Szubert
Ernest Szubert is a clinical operations and drug development leader with more than 10 years of experience in pharmaceutical companies and CROs. He is President of the Polish Association for Good Clinical Practice (GCPpl) and leads its training group. Ernest combines operational leadership with hands-on teaching and has delivered training for clinical research and healthcare professionals. His expertise includes clinical trial documentation, monitoring, electronic systems, informed consent, study oversight and inspection readiness.
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Recommendation
WHO SHOULD ATTEND
• Junior Clinical Research Associate
• Clinical Research Associates II
• Senior Clinical Research Associate
• Clinical Trial Assistant
• Clinical Operations Specialist
• Lead Clinical Research Associate
• QC Specialist
14+
Years of experience
600+
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4,000+
Speakers
25,000+
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