Foundations of Good Clinical Practice and Current Regulations
This highly practical course reviews the essentials of clinical research in drug development and summarises the ethical and regulatory requirements for clinical trials.
Count Every Second Until the Event
Date: 13-14 October 2026
Course Overview
This highly practical course reviews the essentials of clinical research in drug development and summarises the ethical and regulatory requirements for clinical trials. Starting with a refresher on the history of medicinal product regulations and the need for ethics, the course explains in detail the practical applications of GCP and outlines recent major developments in GCP such as ICH E6 (R3), the regulatory systems currently in operation and their impact on the conduct of clinical research.
The course is suitable for those new to clinical research whatever the role and to those wanting a reminder of the ethical and regulatory requirements.
Key Topics
Outline the significant milestones in the history of GCP development
Understand the phases of clinical trials
Review the responsibilities of Sponsors, Investigators and Ethics Committees
Describe the purpose and importance of Good Clinical Practice (GCP) and how to apply it
Understand the ethical and regulatory requirements that must be met through the life of a trial
Gain an understanding of drug safety requirements including definitions and reporting rules
Understand the importance of the Trial Master File and how to assure its complete and accurate
Outline the audit and inspection process and discuss inspection outcomes
Learning Outcomes
Who Should Attend
- Clinical Operations
- Clinical Research Associates
- Clinical Trial Administrators
- Clinical Project Management
- Clinical Process Management
- Research Nurses
- Study Site Co-ordinators
- Those new to clinical research
Meet Your Trainer
Jeannette Dixon
Jeannette has held GCP quality-focused positions since 2008 at various pharmaceutical companies, and started her own consultancy business in 2017, including employment as Director R&D QA at A Gene Therapy biotech company. Prior to transitioning to GCP/GCLP work, she held positions in pharmaceutical training management, project management in Phase I-IV projects, worked as CRA and in academic research laboratories. Jeannette led quality teams and has extensive experience in Quality Management System (QMS) development, managing audits, CAPAs, risk management and inspection readiness activities as well as in hosting several regulatory agency inspections.
Her educational background is a BSc in Medical Sciences, a BSc in Pharmacology, and a Master in Quality Management. She enjoys traveling, cycling, swimming, and painting, and hopes to be able to see a few more deserts in the world
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Register for Your Masterclass
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