Udemy - Clinical Trial Regulation EU 536 - 2014 in Clinical Research torrent

Clinical Trial Regulation EU 536/2014 in Clinical Research



https://CoursePig.com

Published 1/2023
Created by Dr. Vincent Baeyens
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz, 2 Ch
Genre: eLearning | Language: English | Duration: 16 Lectures ( 1h 28m ) | Size: 577 MB

A Complete, Certified Course to Implement and Comply with CTR 536/2014 for EU and non-EU Clinical Research Professionals

What you'll 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.