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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!