Work Packages

The work plan included the development of the Comprehensive Inventory of existing support activities based on an analysis of the survey results. This analysis was also the basis for development of the common Common Strategy to strengthen regulatory sciences, and two curricula, 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.

Three pilot projects aimed to

1. transfer an identified best practice example for training programmes to other European Economic Area (EEA) countries
2. establish a new support activity addressing a gap in regulatory knowledge of significant relevance and to
3. implement the Comprehensive Curriculum.

STARS delivered recommendations ensuring sustainable support of academic research and proposed additional mechanisms based on a comprehensive analysis of needs. STARS had the objective and the potential to complement, coordinate and harmonise regulatory support efforts among Member States and at European level to improve academic health research for the benefit of patients.

The aim was to reach academic researchers very early in the planning of relevant grant applications and research projects. A further objective was to strengthen regulatory knowledge in general by reaching clinical scientists during professional training and qualification.

^{STARS implementation scheme © DLR}

More about: WP 1 | WP 2 | WP 3 | WP 4 | WP 5 | WP 6

WP 1: Project management and coordination

WP Lead: BfArM
Co-Lead: PEI, DLR-PT

• Intermediary for all communications between the beneficiaries and the European Commission (EC);
• Continuous management and monitoring of thework by the whole STARS consortium and all WPs

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WP 2: Establishment of the Comprehensive Inventory

WP Lead: FIMEA
Co-Lead: MA | Contribute: all partners

Currently, there is little comprehensive information available about existing regulatory support activities for academic researchers. The main objective of WP2 was to establish, regularly update and disseminate a comprehensive inventory (CI) of existing support activities for regulatory scientific advice and protocol assistance in Europe. Therefore, a survey was implemented to obtain the required information.

The target groups for the surveys were:

• Academic clinical centres;
• Academic researcher groups and projects;
• Funding organisations active on national and
• European level.

The results from the surveys were the basis for the activities of STARS. STARS identified best practices which are suitable for implementation in other countries. A further objectiveis was to analyse the needs and gaps in regulatory guidance for academic health research.

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WP 3: Effectiveness analysis & strategy development

WP Lead: AIFA
Co-Lead: BfArM, PEI, URPL, MEB, MPA

WP3 provided comprehensive information on the experience of the regulatory agencies carrying out scientific advice requested by academic groups. This information was used to develop the common strategy, which became the STARS road map for planning and implementing support activities such as training programmes. The common strategy was based on the information provided by the surveys carried out in WP2 and 3, but also included specific actions:

• Development and implementation of the core curriculum and the comprehensive curriculum in order to harmonise and strengthen regulatory knowledge of clinical scientists;
• Analysis and support of three pilot projects.

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WP 4: Implementation of the STARS Pilots

WP Lead: AEMPS
Co-Lead: BfArM, PEI, OGYÉI, DLR-PT

WP4 designed and implemented 3 pilots to demonstrate that selected support activities can be implemented efficiently via the methodical approach proposed by STARS.

• Pilot I: Successful transfer of a selected best practice example to one or more European Economic Area (EEA) countries;
• Pilot II: Initiate a novel regulatory support activity in one or more countries in order to address identified gaps;
• Pilot III: Establishment of the comprehensive curriculum developed by WP3 within one or more existing post-graduate programmes in EEA countries.

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WP 5: Additional mechanisms to support academic groups

WP Lead: MEB
Co-Lead: BfArM, PEI, OGYÉI, MPA, VVKT

• Assessing the need for additional mechanisms to sustainably support academic groups in regulatory scientific adviceand protocol assistance procedures;
• Providing recommendations to address the identified needs and gaps. The recommendations will be published and disseminated on a national, European and global level.

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WP 6: Communication and dissemination

WP Lead: BfArM
Co-Lead: DLR-PT, PEI

• Dissemination and communication of the intermediate and final outcomes;
• Development and implementation of strategies and tools for the communication on the national, European, and global level;
• Communication with relevant stakeholder within the innovation and health care environment;
• Two European stakeholder workshops and the subsequent global conference;
• Launch and maintenance of the project’s website.

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