Expert ECTR Course for Clinical Drug Trials in the Netherlands
€ 95.00
This course was previously called “ECTR Expert – NL”. Learn everything you need to know to master the upcoming European Clinical Trial Regulation and the impact on clinical drug trials conducted in the Netherlands. Includes 4 interactive modules, 1 test, and takes 7.5 hours to complete.
LEARNING OBJECTIVES
- Principles of ECTR (EU Clinical Trial Regulation)
- Critical timelines for submission and review of a dossier
- Transition period and expected implementation ECTR
- Submission strategies
- Contents of submission dossier Part I and II
- Preparing and submitting the research dossier in the CTIS portal
- Role of the submitter, the reviewer, and the investigator
- Submission and review requirements and use of CTIS portal
- Deadlines and planning of the medical-ethical review
- How to answer questions from the reviewing ethics committee
- Requirements for the conduct of clinical drug research
- Safety reporting requirements
- Submitting substantial amendments via the CTIS
- How to avoid breaches and quality issues and what to do if they happen
- End of trial reporting, a summary of Clinical Trial Results for Laypersons
- Publication of trial data: requirements and transparency
DESCRIPTION
ECTR stands for European Clinical Trial Regulation. This is the new EU regulation on clinical trials of medicinal products for human use which replaces the existing Directive 2001/20/EC. The ECTR regulation will affect everyone involved in clinical drug research in Europe and will help improve collaboration between all parties involved.
The expert ECTR course for clinical drug trials in the Netherlands helps you understand all the vital aspects of the ECTR regulation and the impact on the setup, submission, and conduct of a drug trial in the Netherlands. You'll learn all strategic elements, from study design to submission, and from approval to conduct. Completion of this course will make you the ECTR expert and be fully prepared for its implementation in 2021.
- 7,5 hours
- 4 modules
- Online ECTR certificate
- Knowledge Test
- Accredited by several quality registers
- Available on desktop, smartphone or tablet
The Expert ECTR course is intended for anyone who is responsible for product development and management, drug research design, and/ or strategic decisions for clinical drug trials in the Netherlands. This course is perfect for research and science coordinators, principal investigators (investigator-initiated research), sponsors, medical directors, head of ClinOps, study directors, project managers, CRAs, monitors, and people responsible for submitting dossiers
The online course takes 7.5 hours and consists of the basic ECTR module, the preparation module, the submission module, the conduct module, and a knowledge test. After completion, you will receive an online ECTR certificate.
Enroll now to get started with the myGCP learning modules on your smartphone, tablet, or desktop computer.
COURSE CONTENTS
Additional information
| Accreditation | |
|---|---|
| Job Role | Investigator, Monitor/CRA, Project Manager, Research Coordinator, Sponsor/CRO Staff |
| Language | |
| Level | |
| Phase of Study | Close-out, Conduct, Design, Foundation, Preparation, Review, Start, Submission |
| Region of Regulation | |
| Regulation |
1 review for Expert ECTR Course for Clinical Drug Trials in the Netherlands
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Published –
I enjoyed the flow of the course and felt that it was nicely structured and planned well.