Prepare for ICH E6 (R3) GCP Update! What’s new and different?
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About this course
Reasons to attend
Stay informed and adapt swiftly with our short yet impactful course on the new GCP guideline. Designed to highlight the key changes and differences in the latest Good Clinical Practice (GCP) guideline, this course provides a focused overview of what's new and will not go into detail of what already existed.Our expert instructor will guide you through the revisions and the current state-of-play, ensuring you grasp the essential upcoming updates and understand how they diverge from previous guidelines. Stay up-to-date and 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 world of clinical research, staying up to date with regulatory changes is crucial for professionals to ensure compliance, uphold patient safety, 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. To empower clinical research professionals with the knowledge and skills needed to navigate these changes seamlessly, we are delighted to present our comprehensive course: "Prepare for the ICH E6 (R3) Update! What's New and Different?This course is a must-attend for a diverse range of professionals across the clinical research spectrum. This course was made to prepare you 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 in 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.
- Streamlined documentation requirements: Gain insights into the updated documentation standards and best practices for efficient record keeping.
- Evolving ethical considerations: Understand the revised ethical considerations and their impact on participant recruitment, informed consent, and data handling.
- Protocol deviations and amendments: Learn about the updated processes for managing protocol deviations and implementing protocol amendments.
- 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 adherence to data integrity, quality control, and documentation standards.
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 committee members
- Clinical project managers
- Clinical operations staff
- Compliance officers
- Research nurses
- Pharmacovigilance specialists
Competencies
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
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