Clinical Trial Regulations are known to be complex on the one hand, on the other hand, there is no way around them. This Regulatory STAR programme is especially 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 life style. After this curriculum, it will seem easy to you and your colleagues will keep referring to you!
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 sponsor and regulatory agencies side. This mixture will guarantee a dynamic and tailored learning environment for all participants.
Course timeAt your own pace; the course will remain available online for you for 3 months after you register for it.
The courses included in the 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-Good Clinical Practice (GCP) refresher for regulatory staff (eLearning)
- European Legislation of Clinical Trials with Medicinal Products (eLearning)
- The European Clinical Trial Regulation 536/2014 - A Clear Outline (webinar)
- Clinical Trial Requirements: Comparing Europe with the USA (eLearning)
When you register for this programme, the eLearning modules are available to you for one year. The webinar is organised several times a year, therefore you can compose your own schedule during 1 year. In this way you can tailor this program to your availabilities and priorities!
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)