Different recommendations and approaches to teaching regulatory aspects during professional training and qualifications throughout Europe are recognised as barrier, limiting quality and consistency of knowledge about regulatory science and implementation of regulatory requirements in academic health research projects.
STARS will coordinate and support harmonisation of activities improving the regulatory knowledge in Europe.
The Core Curriculum will specify aspects of regulatory knowledge that are considered as essential by the STARS consortium including the partners on the European level, EMA, HMA and EUnetHTA. The essential knowledge will broadly address the development of medicinal products and ATMPs in early but also late clinical phases, e.g. the importance of GMP requirements for clinical trial applications. The Core Curriculum will be recommended by the STARS partners to be included in the curricula of relevant basic professional training in medicine, pharmacy, etc.
The Comprehensive Curriculum will address the needs and specify knowledge for specified post-graduate qualifications aiming to include comprehensive knowledge in the field of research and development of medicinal products.
The Advisory Board will be consulted during the development of the Core & Comprehensive Curriculum and requested to provide advice. Industry representatives and associations will be involved for providing expertise in regulatory affairs and medicines development. Learning outcomes (LO) will be established specifying the expected knowledge of participants following training courses and education programmes based on the Core & Comprehensive Curriculum.
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