Prepare for ICH-GCP E6 (R3) Update! What’s new and different? (US Edition)
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 11 DEC 2024 | Prepare for ICH E6 (R3) GCP Update! What's new and different? (US Edition) | Webinar | EUR 200 | Book |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
Stay informed and adapt swiftly with our short yet impactful course on the new Good Clinical Practice (GCP) guideline. Designed to highlight the key changes and differences in the latest ICH GCP E6 revision, this course provides a focused overview of what's new and will not go into detail of what already exists. Our expert instructor will guide you through the revision and the current state-of-play, ensuring you understand what the changes are and why this revision is so important. Stay current and be prepared for the GCP R3 update.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course time
- 2-hour webinar
Course description
In the rapidly evolving globalized world of clinical research, staying up to date with regulatory changes is crucial for professionals to uphold patient safety, ensure compliance, and maintain the highest standards of quality. The upcoming GCP R3 update introduces significant revisions and new guidance that will shape the landscape of clinical research in the years to come. We are delighted to present our comprehensive course: "Prepare for the ICH E6 (R3) Update! What's New and Different?" to empower clinical research professionals with the knowledge and skills needed to navigate these changes seamlessly.This course is a must-attend for a diverse range of professionals across the clinical research spectrum to ensure you are prepared for the upcoming changes. By participating in this course, you will gain an understanding on what is going to change, enabling you to adapt quickly and confidently to the new requirements.
Led by our esteemed expert instructor, renowned for expertise and industry experience, this course will guide you through the key changes and differences introduced in the GCP R3 update. You will delve into essential topics that have a direct impact on your day-to-day operations through all phases of clinical research.
Enroll now and be prepared for the GCP R3 update!
Programme highlight
- Overview of the GCP R3 update: Receive a concise summary of the key content updates introduced in the GCP R3 guidelines.
- Enhanced patient safety measures: Explore the new guidelines and requirements aimed at strengthening patient safety throughout clinical trials.
- to include the use of new technology: Gain insights into the newly added data governance section to ensure fit-for-purpose computerized systems and efficient record keeping.
- Evolving ethical considerations: Understand the revised ethical considerations and their impact on protocol design, participant recruitment, informed consent, and data handling.
- Protocol deviations and amendments: Learn about
- Q&A session: Engage in a live question and answer session to clarify any doubts or seek further clarification on the content updates.
Learning objectives
- Understand and interpret the content updates: Gain a solid comprehension of the changes and nuances introduced in the GCP R3 regulations, allowing you to navigate the updated guidelines effectively.
- Evaluate participant protection measures: Assess the new and revised participant protection measures outlined in the GCP R3 regulations, enabling you to analyse their potential impact and identify key considerations for implementation.
- Understand data management practices: comprehend the revised data management practices outlined in the GCP R3 regulations, ensuring appropriate metadata, adherence to data integrity, quality control, and documentation standards.
- Evaluate expectations for appropriate and proportional risk management of critical to quality factors.
Who should attend
This course is highly beneficial for a wide range of professionals involved in clinical research, including:
- Investigators
- Study coordinators
- Clinical research associates (CRAs)
- Data managers
- Regulatory affairs personnel
- Quality assurance professionals
- Ethics or IRB committee members
- Clinical project managers
- Clinical operations staff
- Compliance officers
- Research nurses
- Pharmacovigilance specialists
- Medical writers
Competencies
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