Clinical Regulatory STAR Programme
About this course
Clinical Trial Regulations are known to be complex on the one hand, on the other hand, there is no way around them. This Clinical Regulatory STAR Programme is specially created for you to get full oversight of clinical study regulations with medicinal products, including the latest updates such as the new EU Clinical Trial Regulations 536/2014.
It is a completely online programme, consisting of a webinar and several eLearning courses. It will allow you to be totally flexible and adapt it to your busy lifestyle. After this curriculum, it will seem easy to you and your colleagues will keep referring to you!
Programme highlight
The courses included in the Cliniccal Regulatory STAR programme are selected to provide the complete picture of regulatory requirements needed for you to work in the field of Clinical Research in the pharma world. The programme is composed of the following courses:
- ICH-GCP E6 (R2) Refresher + Complementary ICH-GCP Refresher for Regulatory Staff - eLearning
- The European Clinical Trial Directive for Medicinal Products – eLearning
- The European Clinical Trial Regulation 536/2014 – A Clear Outline – Webinar
- Local Clinical Trial Legislation in the USA – eLearning
Learning objectives
- This programme includes a GCP refresher course
- Understand the current EU Legislation
- Learn about the regulatory differences between the US and the EU
Who should attend
Whether you have no knowledge of regulations surrounding clinical trials with medicinal products or you have already some experience, but lack the complete overview, this programme is for you. In this STAR programme, you will find a broad variety of expertise levels from both the sponsor and regulatory agencies side. This mixture will guarantee a dynamic and tailored learning environment for all participants.
Competencies
This series of courses cover 83% of the technical competencies needed for a Junior Regulatory Associate as described in the ECCRT Competency Framework
- Scientific Concepts & Research Design (1)
- Ethical & Participants Safety Considerations (3)
- Investigational Product Development and Regulation (6)
- Clinical Studies Operations (GCPs or ISO 14155) (8)
- Study and Site Management (0)
- Data Management and Informatics (2)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
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