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16 November 2018
Strengthening training of academia in regulatory sciences
and supporting regulatory Scientific Advice: STARS
Dr. Wiebke Löbker
Head of Innovation Office, BfArM
16 November 2018
16 November 2018
Strengthening training of academia in regulatory sciences and supporting regulatory scientific advice: STARS CSA
STARS
Aims & objectives of the project
Brief outline of the methodology
Deliverables/outcomes expected
16 November 2018
Aims & Objectives
Overall aims:
to improve the direct regulatory impact of results obtained in (early) medical research.
to reach academic researchers very early in the planning of relevant grant applications.
to strengthen long-term regulatory knowledge in general by reaching clinical scientists during professional training and qualification.
16 November 2018
Aims & Objectives
Objectives of STARS:
To deliver consensual recommendations ensuring sustainable support of academic research.
To propose additional support mechanisms based on a comprehensive analysis of needs.
To complement, coordinate and harmonize regulatory efforts among Member States and at European level to support academic health research for the benefit of patients.
16 November 2018
Methods/Plans
• To develop and sustain a Comprehensive Inventory of existing support activities based on a detailed analysis of the currently established programmes.
• To develop and consent a Common Strategy to strengthen regulatory sciences
• To develop a Core Curriculum on essential knowledge for the professional training of clinical scientists and a Comprehensive Curriculum defining relevant knowledge for specific post-graduate programs.
16 November 2018
Methods/Plans
• To implement three academic-regulatory pilot projects with the aims
(i) to transfer an identified best practice example for training programmes to other EEA countries,
(ii) to implement a new support activity addressing a gap in regulatory knowledge of significant relevance
(iii) to implement the Comprehensive Curriculum.
16 November 2018
Dissemination and communication • White Paper; Website; articles in lay press
• European stakeholder workshops Months 18 and 34 (follow-up)
Relevant national, European and global stakeholders
The academic health research community
National, European and global funding organisations active in health research support
• Global Regulatory Science conference Month 34
Relevant global stakeholders
The academic health research community
Relevant international organisations, initiatives or projects
Patients, European citizens and broader public
16 November 2018
Outcomes and deliverables
CSA STARS - Work Package Interaction and Outcomes WP3
Analyse capacities, Common strategy,
Core & Comprehensive
Curriculum
WP4 Pilots: Transferring
best practices, addressing gaps,
implementing the Comprehensive
Curriculum
Academia Europe and MS
Stakeholder Europe and MS
Industry Europe and MS
Representatives & Associations
WP2 Analyse of
existing support activities,
Comprehensive Inventory
WP5 Continuous assessment,
White Paper and Final Report
WP 6 Dissemination and Communication,
Stakeholder Workshops and
Conferences
Improving regulatory knowledge, success and direct regulatory impact
of academic health research
HMA EMA
EUnetHTA
Information Contribution
Feedback Support
Information Contribution
WP 1 Management and
coordination
STARS Workpackages
16 November 2018
Outcomes and deliverables
CSA STARS - Work Package Interaction and Outcomes WP3
Analyse capacities, Common strategy,
Core & Comprehensive
Curriculum
WP4 Pilots: Transferring
best practices, addressing gaps,
implementing the Comprehensive
Curriculum
Academia Europe and MS
Stakeholder Europe and MS
Industry Europe and MS
Representatives & Associations
WP2 Analyse of
existing support activities,
Comprehensive Inventory
WP5 Continuous assessment,
White Paper and Final Report
WP 6 Dissemination and Communication,
Stakeholder Workshops and
Conferences
Improving regulatory knowledge, success and direct regulatory impact
of academic health research
HMA EMA
EUnetHTA
Information Contribution
Feedback Support
Information Contribution
WP 1 Management and
coordination
STARS Workpackages
Outcomes Comprehensive Inventory Common Strategy Core & Comprehensive Curriculum Pilots: Transferring best practice and
addressing gaps STARS recommendations for additional
support mechanisms
16 November 2018
„… To fill the gaps in scientific needs for the support of regulatory decisions and the minimization of drug-associated risks in the general population“
(German Science Council 2014)
Regulatory Research
16 November 2018
Contact Federal Institute for Drugs and Medical Devices Kurt-Georg-Kiesinger-Allee 3 D-53175 Bonn Contact person Dr. Wiebke Löbker innovation@bfarm.de www.bfarm.de
Thank you very much for your attention!
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