Clinical Trial Regulation EU 536/2014 in Clinical Research

Description

Updates:

[January 2024]: Lecture 14  - CTIS Training material catalogue updated with latest information

[March 2023]: Training document material from EMA updated and lecture 14 updated accordingly; New Q&A document from the CTIS/CTR query management working group attached (lecture 15)

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On 31st January 2023, the Clinical Trial Regulation (CTR) 536/2014 came into force in the European Union (EU) and repealed the Clinical Trials Directive 2001/20/EC. With this Regulation, the EU harmonises the procedures for carrying out clinical trials across the EU states and  simplifies the clinical trial approval process through a Clinical Trials Information System (CTIS).

This course provides clinical research professionals in Sponsor and CRO organizations as well as investigational sites and study staff with an essential understanding of the CTR to help implement and comply with it.

The programme highlights the most important of these key requirements and how these are impacting all EU as well as non-EU sponsors conducting clinical trials in the EU.

My name is Dr. Vincent Baeyens PhD, I have more than 20 years of experience in running Clinical Trials in Global and mid-size Pharma and Biotech settings.

Benefits of attending this course include:

• Gain an overview of the Clinical Trial Regulation (CTR) to conduct trials in the EU

• Understand why changes to the Directive 2001/20/EC were made

• Learn and understand the timeline for CTR introduction and transition period

• Learn the essential definitions of terms under the CTR

• Understand how the Clinical Trials Information System (CTIS) is set up

• Understand the submission process of clinical trials in the CTIS

• Understand the validation, assessment and decisions process of clinical trials under the CTR

• Learn the process to submit a Substantial Modification of the protocol

• Learn the process to submit a new Member State in an ongoing study

• Identify the safety and other reporting obligations

• Grasp the risks and challenges associated with the CTR in sponsor organizations

• Prepare a high-level submission planning under CTR

Quizzes and assignments are proposed along your journey to test your knowledge.

To facilitate the learning of beginner students, the course has been broken up on purpose in small lectures. If you are a more advanced student, you can increase the speed of lecture to learn the course at your desired pace.

Important remark: Please note that this course does not go into the technicalities of the CTIS. References to adequate resources on the topic are provided.

Feel free to look at the content of the course to know more and contact me any time if you have any questions!

I am looking forward to seeing you inside the course!

Sincerely,

Vincent

What You Will Learn!

• Gain an overview of the Clinical Trial Regulation (CTR) to conduct trials in the EU
• Understand why changes to the Directive 2001/20/EC were made
• Learn and understand the timeline for CTR introduction and transition period
• Learn the essential definitions of terms under the CTR
• Understand how the Clinical Trial Information System (CTIS) is set up
• Understand the submission process of clinical trials
• Understand the validation, assessment and decisions process of clinical trials under the CTR
• Learn the process to submit a Substantial Modification of the protocol
• Learn the process to submit a new Member State in an ongoing study
• Identify the safety and other reporting obligations
• Grasp the risks and challenges associated with the CTR in sponsor organizations
• Practical exercise: Conduct a risk assessment of a regulatory submission with the CTR
• Practical exercise: Planning a regulatory submission in line with the CTR

Who Should Attend!

• The course is relevant for all clinical research professionals working in regulatory, clinical operations, project management, pharmacovigilance, quality assurance, vendor/CRO professionals, study sites

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