european medicines agency | - strengthening training of … · national, european and global...
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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
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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
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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.
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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.
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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.
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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.
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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
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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
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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
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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
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16 November 2018
Contact Federal Institute for Drugs and Medical Devices Kurt-Georg-Kiesinger-Allee 3 D-53175 Bonn Contact person Dr. Wiebke Löbker [email protected] www.bfarm.de
Thank you very much for your attention!