EU Clinical Trial Regulation (CTR) and Serious Breaches
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About this course
Reasons to attend
This course on the EU Clinical Trial Regulation (CTR) and the Notification of serious breaches of the CTR or the clinical trial protocol is an essential training program for professionals working in clinical research. During this webinar, our expert instructor will give you an overview of the guidelines and regulations governing clinical trials in Europe and the importance of maintaining the highest ethical standards in conducting clinical studies. You will gain a comprehensive understanding of the key aspects of clinical trial regulations and the new obligations of reporting serious breaches. Join us to enhance your knowledge and stay up to date with the latest developments in clinical trial regulations.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course time
- 2-hour webinar
Course description
This course was designed to provide you with a comprehensive understanding of the critical aspects of clinical trial regulations and the potential consequences of serious breaches in clinical studies. This course is led by an industry expert with extensive experience in clinical research, and it will cover an overview of the guidelines and regulations governing clinical trials in Europe and the importance of maintaining the highest ethical standards in conducting clinical studies. You will gain a comprehensive understanding of the key aspects of clinical trial regulations and the new obligations of reporting serious breaches. Through a combination of lectures and case studies, you will learn how to identify potential risks and manage serious breaches if they occur. You will also gain an understanding of the new Clinical Trials Regulation (CTR), which is set to replace the Clinical Trials Directive, and how it affects the conduct of clinical trials in Europe. Upon completion of this course, you will be equipped with the knowledge and tools necessary to ensure that your clinical trials are conducted in compliance with the latest regulations and guidelines. Join us to enhance your knowledge and stay up to date with the latest developments in clinical trial regulations.Programme highlight
- Overview of the guidelines and regulations governing clinical trials
- Understanding the key aspects of the Clinical Trials Regulation (CTR) and its impact on clinical trials
- Identifying potential risks and managing serious breaches in clinical studies
- Maintaining ethical standards in conducting clinical trials
- Practical examples and case studies to demonstrate the impact of serious breaches.
Learning objectives
- Overview of the guidelines and regulations governing clinical trials
- Understanding the key aspects of the Clinical Trials Regulation (CTR) and its impact on clinical trials
- Identifying potential risks and managing serious breaches in clinical studies
- Maintaining ethical standards in conducting clinical trials
- Practical examples and case studies to demonstrate the impact of serious breaches.
Who should attend
This short course on EU Clinical Trial Regulation (CTR) and the Notification of serious breaches of the CTR or the clinical trial protocol is designed for professionals working in the clinical research industry. This includes individuals working in clinical operations, regulatory affairs, quality assurance, compliance, and ethics.
The course is also suitable for individuals interested in understanding the legal and ethical requirements for conducting clinical studies. If you are responsible for managing clinical trials or involved in any aspect of the clinical research process, this course is essential to ensure that you are up to date with the latest obligations governing clinical trials.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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