Clinical Trial Regulation EU 536/2014 in Clinical Research

Complete Certified Course on Implementing and Applying mandatory CTR for EU and non-EU Clinical Research Professionals

Created by: Dr. Vincent Baeyens
Expert in Clinical Research and Good Clinical Practice

What Will I 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

Requirements

• No prerequisite is needed for this course.

Target audience

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