ADVANCE Presented by: Malgorzata Leszczynska on behalf of Xavier - - PowerPoint PPT Presentation

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Nov 16, 2022 211 likes •302 views

A ccelerated D evelopment of VA ccine be N efit-risk C ollaboration in E urope ADVANCE Presented by: Malgorzata Leszczynska on behalf of Xavier Kurz Best Evidence Development An agency of the European Union Aim Long-term vision : The

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An agency of the European Union

Presented by: Malgorzata Leszczynska on behalf of Xavier Kurz Best Evidence Development

Accelerated Development of VAccine beNefit-risk Collaboration in Europe ADVANCE

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Aim

Long-term vision:

The ADVANCE vision is focused on “timely and best

evidence on vaccine benefits and risks”.

The mission is to establish a Blueprint for a validated

and tested best practice framework that could rapidly provide robust data on vaccine benefits and risks to support accelerated decision making.

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Need for partnership

Benefit: Risk

Burden of Diseases

Vaccination Coverage Vaccine Safety

Vaccine Effectiveness

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Participating Public Health Institutes

Full partners: ECDC (SE) / WIV-ISP (BE) / RVH (NL) / SSI (DK) /

ASLCR (IT)

Associate partners: UK / SMI (SE) / THL (FI) / KEELPNO &

ESDY (EL) as well as Slovenia / Bulgaria / Hungary

Participating Regulatory Agencies

Full partners: EMA / MHRA (UK) / AEMPS (ES)
Associate partners: AIFA (IT) / ANSM (FR) / EOF (EL) / VVKT

(LT) / JAZMP(SI) / WUM (PL) / IMB (IE)

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Challenges

Diversity of stakeholders:

Regulatory agencies, public health institutes, vaccine

manufacturers, … Challenges on technical, governance and legal level

Data sources
Analytical methods for integrated B/R
Coordination, overlap
Transparent governance rules
Increasing (complexity of) obligations

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WP4

Methods Creation of Synergies Proof of concept studies Data sources Best practice

WP5 WP1 WP6 WP3 WP2 WP7

Blueprint for benefit-risk monitoring

ADVANCE PROJECT WORKPLAN

Project Management & Communication

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Role of European Medicines Agency

Development of best practice and code of conduct for benefit-risk monitoring of vaccines (WP 1)

Stakeholder needs and challenges (several workshops)
Landscape analysis and models for public-public and public-private

interactions

Best practice guidance & code of conduct
Communication strategy around vaccine benefit-risk and public private

collaboration

Leading to code of conduct/guidance, proposal for proof of concept studies and white paper Led by European Medicines Agency & SP MSD

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