Foundational ICH-GCP E6 (R3) Training

Reasons to attend

­Did you know that your clinical studies need to comply with the Good Clinical Practice (GCP R3) guideline?

Enhance your expertise with our one-day course on the updated ICH GCP E6 (R3) guideline. This informative training provides a comprehensive overview of the entire document, ensuring that you are fully equipped to meet the latest Good Clinical Practice standards.

You will gain in-depth knowledge of essential GCP principles, including the implementation of risk-based approaches and the importance of data integrity. This course is designed to empower professionals to navigate regulatory requirements effectively, foster a culture of compliance and excellence in clinical trials.

What's included?

• Documents and materials related to this course are included
• Globally recognised certificates awarded after test completion

Course schedule

We provide this course in two distinct formats: Classroom OR Online

1-Day face-to-face: 09:00 - 17:00

2 webinar sessions of 3 hours

Course Description

This course covers all the ICH-GCP in its current version (R3) and will cover the responsibilities of every stakeholder involved, as well as its implementation in practice.

Without training on the ICH-GCP requirements, or without experience in clinical research, professionals are not always aware of the legal regulations that govern clinical studies, including post-marketing trials. ICH-GCP is the guideline ruling all clinical research including its conduct, performance, monitoring and reporting of the results. This course focuses on the requirements of GCP in clinical studies with pharmaceuticals.

During the course, participants will gain a thorough understanding of the entire ICH GCP E6 (R3) guideline, focusing on both foundational principles and recent updates. You will learn how to effectively implement risk-based strategies in clinical trials, enhancing efficiency and compliance while maintaining participant safety. The course also delves into quality management principles, emphasizing the importance of data integrity and governance in today’s digital landscape.

Through a combination of expert-led lectures, interactive workshops, and group discussions, you will engage in practical exercises designed to reinforce key concepts and facilitate real-world application. This training is ideal for all clinical research professionals who are committed to maintaining compliance and excellence in their work. By the end of the course, you will be well-prepared to navigate regulatory requirements confidently and implement effective strategies that improve trial outcomes.

Join us to deepen your understanding of ICH GCP E6 (R3) and elevate your contributions to clinical research.

If you'd like to see our GCP Refresher course then you can find it here.