STARS Core Curriculum
The Core Curriculum specifies aspects of regulatory knowledge that are considered as essential by the STARS consortium and relevant stakeholders. It is mainly targeted at graduate students (bachelor and master’s degree) interested in regulatory science and in gaining basic regulatory knowledge / training of European regulations on medicinal products and borderline between medicines and medical devices.
The Core Curriculum aims to provide attendees with an overview of regulatory science and the regulatory system in Europe, giving an overview on development pathways, on the EU legislation and the use of guidelines, with an introduction on the core parts of a clinical trial/marketing authorisation application (quality, non-clinical and clinical) and on the post-marketing processes.
It is mainly targeted at graduate students (bachelor and master’s degree) interested in regulatory science and in gaining basic knowledge / training of European regulations on medicinal products and borderline between medicines and medical devices.
Universities will provide graduates with key regulatory knowledge to enrich their professional education for a future position in different areas, such as drug research and development, regulatory authorities for medicinal products, as well as the pharmaceutical industry.
The STARS consortium recommends that the Core Curriculum could also be offered to those professionals who are willing to improve, refresh and / or deepen their basic knowledge in regulatory science.
The Core Curriculum has one core module, which covers the basic knowledge in regulatory science illustrating the different levels of regulatory requirements applying at different stages during product development.
STARS Core Curriculum © STARS project
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For more information on the content of the Core Curriculum modules and learning outcomes, please download the accompanying document.