The STARS consortium developed a curriculum to strengthen the awareness of regulatory science in academia, on the base of the survey data and dialogue with stakeholder during two STARS stakeholders’ workshops.
The focus is on the development of a Core Curriculum dedicated to basic regulatory training, and a Comprehensive Curriculum focused on a more in-depth training on specific regulatory requirements.
Aim of the STARS Curricula:
- To achieve a harmonised and common level of regulatory knowledge
- To meet the different needs and requirements of the national education systems
- Not to substitute or replace any existing curricula in the EU, but to identify and to address current gaps
The curricula concepts have been conceived as guidance and are considered as a superordinate recommendation for an EU-harmonized concept to achieve a harmonised and common level of regulatory knowledge in academia in the near future. It is addressed to universities or post-graduate course in the EU member states. The STARS curricula do not aim to substitute or replace any existing European curricula, and can be adapted according to the different needs and requirements of the respective national education systems of the European Member States.
- the Core Curriculum specifying essential knowledge for the professional training of clinical scientists and
- the Comprehensive Curriculum defining relevant knowledge for specific post-graduate programmes.
STARS Curricula © STARS project
Background and Data Basis for Development:
- Comprehensive results of STARS surveys in 18 NCAs:
- Analysis of training offered to graduate students, post-graduate students and healthcare professionals
- Top 3 training topics: pharmacovigilance; regulatory system/legislation; clinical studies
- Top activities and materials offered: lectures and guidelines
- Strong recommendation to include the “Regulatory system/legislation” topic in any educational support activities
- Outcome of two European stakeholder’s workshops in November 2020 and November 2021:
- Lack of basic regulatory knowledge
- Proposal for “train the trainer” concept as an appropriate strategy
- Proposal for a harmonised and standardised approach to establish a modular system for basic regulatory education
- Consensus on the need of special training at a deeper level regarding some challenging topics.
For more information: please download the accompanying document.