Clinical Trial Regulation EU 536/2014 in Clinical Research

🎉 Course Title: Complete Certified Course on Implementing and Applying Mandatory CTR for EU and Non-EU Clinical Research Professionals

📅 Important Updates:

• January 2024: Lecture 14 updated with the latest CTIS Training material catalogue information.
• March 2023: Training document material from EMA updated; Lecture 14 & 15 updated and a new Q&A document from the CTIS/CTR query management working group added (Lecture 15).

🚀 Introduction to Clinical Trial Regulation (EU) 2014/536: On January 31st, 2023, the Clinical Trial Regulation (CTR) 536/2014 came into effect in the European Union (EU), replacing the Clinical Trials Directive 2001/20/EC. This significant change aims to harmonize clinical trial procedures across EU states and simplify the approval process through the use of a Clinical Trials Information System (CTIS).

👩‍⚕️ Course Overview: This comprehensive course is designed for clinical research professionals in Sponsor and CRO organizations, investigational sites, and study staff who wish to fully understand and implement the CTR. It is essential for all EU as well as non-EU sponsors conducting clinical trials within the EU to stay informed and compliant with these new regulations.

🧠 Course Instructor: Your guide through this complex landscape is Dr. Vincent Baeyens PhD, an industry veteran with over 20 years of experience running clinical trials in Global and mid-size Pharma and Biotech settings. His expertise will provide you with the knowledge and tools needed to navigate the CTR successfully.

🎓 Course Benefits:

• Gain an overview of the Clinical Trial Regulation (CTR) for conducting trials in the EU.
• Understand the rationale behind changes from the Directive 2001/20/EC.
• Learn about the timeline and transition period for CTR implementation.
• Master essential definitions of terms under the CTR.
• Understand the setup and functioning of the Clinical Trials Information System (CTIS).
• Grasp the submission process, including validation, assessment, and decisions under the CTR.
• Learn how to handle substantial modifications of protocols and add new Member States to ongoing studies.
• Identify safety and reporting obligations.
• Understand the risks and challenges associated with CTR in sponsor organizations.
• Prepare a high-level submission planning under CTR.
• Engage with quizzes and assignments tailored to test your knowledge throughout the course.

📖 Course Structure: The course is broken down into small, digestible lectures, accommodating both beginner and advanced students. You can adjust the speed of lecture playback to suit your individual learning pace.

👉 Additional Notes:

• This course does not delve into the technical details of CTIS but provides references to adequate resources for those aspects.
• We strongly encourage participants to engage actively with the content and reach out with any questions or inquiries during their learning journey.

📚 Learning Resources: The course includes a variety of materials, including lectures, quizzes, assignments, and a resource guide for further study on the technicalities of CTIS.

🚀 Join the Course Today! Embark on your journey to mastering the Clinical Trial Regulation (EU) 536/2014 with confidence. Enroll now and take the first step towards becoming a seasoned expert in clinical research compliance.

Sincerely, Vincent 🌟