- transfer an identified best practice example for training programmes to other European Economic Area (EEA) countries,
- establish a new support activity addressing a gap in regulatory knowledge of significant relevance and
- implement the Comprehensive Curriculum.
Transfer of an identified best practice example to (an) other EEA member state(s)
For Pilot I a best practice example identified in WP2 and WP3 was chosen. The best practice example was selected based on criteria taking into account the potential impact on the desired outcome and the feasibility of transferring the programme to other countries and if needed to make necessary adaptations for transfer to other countries.
The best practice example identified and led to a comprehensive online training course titled 'The Winding Road from a Brilliant Idea to Drug Approval: An Online Course in Regulatory Science for Academic Researchers'. STARS partners ensured the efficient implementation of Pilot I based on the identified needs and requirements.
Pilot I results (now available!)
Addressing gaps – initiation of a novel support activity for improving success on regulatory Scientific Advice
For Pilot II, STARS addressed a gap of significant relevance – a need that was not addressed by any existing support activity.
Thus, Pilot II developed a new support activity. It was based on the experiences yielded during the analysis, planning and implementation of Pilot I. The available information about support activities for regulatory Scientific Advice was taken into account, as provided by the Comprehensive Inventory (WP2).
A detailed programme for implementation was prepared with clear defined outcomes. Selection took into account feasibility but also the possibility to extrapolate the results to other Member States or organisations, the perceived need for the action, and operability characteristics.
As the support activity was applied in specific EEA country (Spain), the final implementation plan identifed the requirements to be taken into account in order to implement the pilot addressing the specific gap. Appropriate partners were selected to ensure efficient implementation of the second pilot based on the identified needs and requirements.
Pilot II results (now available!)
Implementing the Comprehensive Curriculum
For Pilot III, STARS collaborated with relevant academic post-graduate programmes in order to implement the Comprehensive Curriculum established in WP3. According to modern education methods, learning outcomes (LO) specifying the expected knowledge for students (see Task 3.4) are now available.
Pilot III validated the LOs defined in the Comprehensive Curriculum by implementation into 1 European/international postgraduate training course. The experiences yielded during the implementation for the Comprehensive Curriculum informed and improved the further implementation of the Comprehensive Curriculum by post graduate programmes in Europe and potentially also globally.
The appropriate partners were selected to ensure efficient implementation of the third pilot based on the identified needs and requirements.
The target audiences were health care professionals from academia across EEA countries with relevant professional training and education. The efficiency of the training was determined by collecting feedback from the participants based on LOs / key performance indicators. The results were used to improve benefits and effectiveness of the programme.
Pilot III results (now available!)