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

seeders: 1
leechers: 4
updated:
Download torrent
Added by freecoursewb in Other > Tutorials
Download Fast Safe Anonymous
movies, software, shows...
  • Downloads: 5
  • Language: English

Files

[ CoursePig.com ] Udemy - Clinical Trial Regulation EU 536 - 2014 in Clinical Research
  • Get Bonus Downloads Here.url (0.2 KB)
    • ~Get Your Files Here ! 1. Introduction
    • 1. Welcome and Objectives.mp4 (76.8 MB)
    • 1.1 My Linked In Profile.html (0.1 KB)
    • 2. Key Facts.mp4 (20.8 MB)
    • 2.1 CTR 536 2014 - Overview of Chapters and Articles.pdf (108.8 KB)
    • 2.2 REGULATION 536 2014.pdf (757.0 KB)
    • 3. Why Changes.mp4 (22.7 MB)
    • 4. Timeline for Introduction and Transition Period.mp4 (28.3 MB)
    • 5. Definitions.mp4 (60.5 MB)
    • 5.1 2017_06_28_recommendation_on_axmps.PDF (416.3 KB)
    • 6. What is EU CTR 5362014.html (0.2 KB)
    2. Initial Authorization Procedure
    • 1. Submission.mp4 (48.1 MB)
    • 1.1 roles-permissions-matrix-summary-sponsors-workspace-ctis-training-programme-module-07_en.pdf (541.5 KB)
    • 2. Validation and Assessment.mp4 (31.8 MB)
    • 3. Decision.mp4 (22.4 MB)
    • 4. Initial Authorization Procedure.html (0.2 KB)
    3. Submissions and Reporting during a Clinical Trial
    • 1. Substantial Modification.mp4 (34.9 MB)
    • 2. Addition of a Member State.mp4 (20.9 MB)
    • 3. Safety and Other Reporting Obligations.mp4 (18.9 MB)
    • 4. Public Disclosure of Data.mp4 (13.8 MB)
    • 5. Submissions and Reporting during a Clinical Trial.html (0.2 KB)
    4. Risks and Challenges
    • 1. Risks and Challenges.mp4 (30.4 MB)
    • 2. Practical exercise Risk Assessment of a clinical trial with CTR 5362014.html (0.2 KB)
    5. Practical Guide to CTIS Training Material Catalogue
    • 1. CTIS Training Material Catalogue.mp4 (45.7 MB)
    • 1.1 ctis-training-materials-latest-updates_en September 2022.pdf (462.8 KB)
    • 1.2 Link to the EMA Modular Training Landing Page.html (0.2 KB)
    6. Frequently-Asked Questions and Answers
    • 1. Frequently-Asked Questions and Answers.mp4 (88.3 MB)
    • 1.1 CTR 536 2014 - QandA Version 6.2 September2022.pdf (1.3 MB)
    7. Practical Exercise Planning a Submission in line with the EU CTR 5362014
    • 1. Planning a submission of Clinical Trial under the Clinical Trial Regulation.html (0.2 KB)
    8. Conclusion
    • 1. Conclusion and Perspectives.mp4 (8.7 MB)
    • Bonus Resources.txt (0.4 KB)

Description

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.



Download torrent
576.6 MB
seeders:1
leechers:4
Udemy - Clinical Trial Regulation EU 536 - 2014 in Clinical Research
Loading...