Impact of the EU CTR 536/2014 on your organisation
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About this course
What's included?
- Documents and materials related to this course are included
Course schedule
- Course time: Webinar of 1h
Course Long Description
The European Clinical Trial Regulation (CTR) 536/2014 is the legislation which harmonises regulatory processes and information of interventional clinical trials in Europe. To meet CTR requirements, entries in the European Clinical Trials Information System (CTIS) are mandatory. CTIS was launched on 31 January 2022, marking the entry into application of the CTR, superseding the EU Clinical Trial Directive 020/2001 (CTD). After one year of transition during which sponsors could still submit Clinical Trials under the CTD, 31 January 2023 marks the obligation to submit any new Clinical Trials according to the new rules (CTR).On 31 January 2025 all Clinical Trials in Europe will have to be run under the CTR. Note: This course is not intended to go in details about the content of the CTR and the technical aspects of the CTIS, though it will provide references where to find resources on this topic.Programme highlight
- Purpose of the webinar
- CTR high level content
- Key impacts for organisations
- Your role in the transition
- Resources
- Q&A
Learning objectives
- Understand the key features of the Clinical Trial Regulation 536/2914 and CTIS, and changes compared to the CTD.
- Understand CTR strengths and limitations
- Understand what compliance to CTR entails and key changes to manage
- Understand how to support your organisations during the transition period
- Learn about first experiences of submitting clinical trial under CTR
- Know existing resources
Who should attend
This course is developed for senior level people in charge of organisations who need to implement and apply the CTR.
In particular the pharmaceutical industry and CRO Heads of Global Clinical Operations, Heads of Global Regulatory Sciences, Heads of Regulatory Operations, Heads of Local Regulatory Affairs, Head of Regional Clinical Operations, Heads of Academic Clinical Trial Units should attend this course.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 (0)
- Clinical Studies Operations (GCPs or ISO 14155) (3)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
Anonymous
Aquilon Pharmaceuticals S.A.