The European Clinical Trial Regulation (CTR) 536/2014 – Webinar
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 16/11/2023 | The European Clinical Trial Regulation 536/2014 - A Clear Outline | Webinar | EUR 145.00 | Book |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
The European Clinical Trial Regulation 536/2014, of April 2014, is to become the mandatory unique rule governing clinical trials in Europe. You need to understand the new requirements and major changes compared with the current legislation, but you have no time to read the full version of the European Clinical Trial Regulation 536/2014? For this 1.5-hour interactive webinar, we apply the “less is more” principle with schematic presentations helping you to get a crystal-clear view of the changing legislative landscape in order to prepare you and your organisation for a smooth transition. The regulation will have no more surprises to you.
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
- Live online training: 1.5h
Course Description
You will learn about scope, definitions, application and validation processes, mandatory notifications, rules for safety reporting, timelines and time table for implementation of the European Clinical Trial Regulation 536/2014. This webinar is your “rough guide” to grasp the main rules prior to its implementation. In addition, you will have the opportunity to ask questions during and after the session. The session ends with an extensive Q&A round. The webinar will allow participants to attend from all over the world, without any travel requirements.
Programme highlight
- Framework of the current and future European Clinical Trial Legislation
- The European Clinical Trial Regulation 536/2014:
- New definitions
- Scope
- Clinical Trial Application Process
- Mandatory Notifications
- Safety Reporting
- Time Table for Implementation
Learning objectives
- Grasp the main processes and requirements of the European Clinical Trial Regulation 536/2014.
- Understand what is needed to come to implementation of the Regulation
Who should attend
Everyone involved in clinical research including: staff of pharmaceutical companies, contract research organisations (CROs), investigators, site personnel and ethics committee members. People from clinical research, regulatory affairs and pharmacovigilance departments within the pharmaceutical industry.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (1)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (2)
- Study and Site Management (0)
- Data Management and Informatics (1)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained
Trainers
Jutta Neumann
Excellent webinar! To deal with a topic (CTR 536/2014), where about 50% of the eggs are not yet laid, the presenter tackled this brilliantly and succeeded to make the little that is known very clear. Excellent, fast responses, good interpretation by the moderator of the sometimes cryptic questions.
Good overview on the impact of the new Clinical Trial Regulation coming into force in 2016. Gives a well structured overview to prepare internal processes accordingly.
Ann Sharon Jannu
Bracco Diagnostics, Inc
I attended the webinar on "The European Clinical Trial Regulation 536/2014 - A Clear Outline" in March and I must say I thoroughly enjoyed it. The webinar gave us a very clear overview of the new Regulation with up to date information presented in the most engaging manner. The level and the nature of the webinar was exceptional with concrete examples making us understand the Regulations well. The interactivity resulted in more information flowing through, whilst making the webinar more interesting.
Very well organized and highly satisfied!
Bobbie Dudley
Malincrodt
The instructor provided a clear and concise instruction - The trainer went through, step-by-step with the EU process for submission. The "old" way and the "new" way.