Basic Good Clinical Laboratory
Practice (GCLP) – EMA Requirements for Laboratories Performing Clinical
Trial Sample Analysis Masterclass
The analysis and evaluation of clinical trial samples are critical components of clinical research and contribute directly to the assessment of participant safety, efficacy endpoints and regulatory submissions.
Live Online Masterclass
29–30 October 2026 | Two Half-Day Sessions
Daily: 13:00–17:00 UK GMT | 14:00–18:00 CET | 09:00–13:00 US EDT
Course Overview
The analysis and evaluation of clinical trial samples are critical components of clinical research and contribute directly to the assessment of participant safety, efficacy endpoints and regulatory submissions. Laboratories performing work in support of clinical trials are expected to implement appropriate quality systems that ensure data integrity, reliability and compliance with regulatory requirements.
This course provides a practical introduction to Good Clinical Laboratory Practice (GCLP) principles based on the EMA Reflection Paper for Laboratories that Perform the Analysis or Evaluation of Clinical Trial Samples (EMA/INS/GCP/532137/2010).
Participants will gain an understanding of the quality and operational requirements applicable to clinical trial laboratories, including organisation and responsibilities, quality systems, sample management, data integrity, documentation practices, subcontracting arrangements and inspection readiness.
The course combines regulatory expectations with practical implementation examples and opportunities to discuss best working practices and common compliance challenges.
The course is suitable for laboratory personnel, QA professionals and clinical research staff who are new to GCLP, require a practical understanding of laboratory requirements supporting clinical trials, or would benefit from a refresher on GCLP principles and requirements.
Key Topics
Practical GCLP requirements for laboratories analysing clinical trial samples.
Learning Outcomes
Who Should Attend
- QA Directors and Managers in pharmaceutical and medical-device organisations
- R&D Directors and Managers
- Clinical Laboratory Directors and Managers
Meet Your Trainer
Orit Galperin, M.Sc., CQE
Orit Galperin is a Quality Assurance professional with extensive international experience in regulated laboratory environments, specialising in GLP and GCLP compliance.
She has extensive experience in developing and implementing Quality Management Systems, conducting hundreds of GLP and GCLP audits worldwide, supporting organisations in achieving inspection readiness, and providing practical solutions to site-specific compliance challenges.
Orit combines technical Quality Assurance expertise with strong interpersonal and communication skills. Her constructive and collaborative approach helps organisations understand audit observations, implement effective corrective actions and achieve sustainable improvements in their quality systems.
Key Areas of Expertise
- GLP/GCLP global auditing and consulting
- GLP/GCLP training
- Managing global GMP/GCP/PV/IT expert auditors
- GCLP compliance gap analysis for clinical laboratories
- Mock inspections; preparation for regulatory inspections
- Risk management in GLP/GCLP
Speak to Your Delegate Manager
We’re here to help!
If you have any questions, need support, or would like us to assign a dedicated team member to assist you, please don’t hesitate to reach out.
Register for Your Masterclass
Complete the registration form with your delegate and billing details. We will assign a dedicated Delegate Relationship Manager to assist you with your booking.
Your manager will contact you from [email protected] to confirm availability, arrange your invoice and guide you through the next steps.
Digital certificate included.
This masterclass will not be recorded.