Common use of WHO ARE WE? Clause in Contracts

WHO ARE WE?. PROTECT is a multi-national consortium of 34 public and private partners including academics, regulators, SMEs and EFPIA companies with extensive experience in pharmacovigilance. In orer to efficiently manage the PROTECT project, the research agenda was split into 7 sub-projects – work packages (WPs) which are complemented by a multi-layer management and governance structure including Consortium Assembly, Steering Committee and external expert group (External Advisory Board). Project coordination and management consists of (Deputy) Coordinator, PROTECT Management Support Team and Managing Entity of the IMI JU funding. The relationship between individual entities is shown in the diagram below. Managing Entity of IMI JU funding Steering Committee WP1 co-leaders = Coordinator & Deputy Coordinator WP2 co-leaders WP3 co-leaders WP4 co-leaders WP5 co-leaders WP6 co-leaders WP7 co-leaders WP 1 Management & Administration = PROTECT Management Support WP 2 Framework of PE studies WP 3 Methods for SD WP 4 WP 5 New tools for B/R integration & data collection representation WP 6 Validation studies WP 7 Training & communication External Advisory Board External independent experts Consortium Assembly All participants Seven WPs are subdivided into six scientific (each addressing one of the objectives above) and one managerial packages which are distinct from one another by their specific objectives, their methodologies, the type of data they use and the required expertise, but complimentary with regard to the overall project. These WPs can be described as  one WP concerned with the aspects of the organisation and management of PROTECT: WP1: Project management and administration  four “vertical” WPs targeting the specific scientific objectives and methodological developments WP2: Framework for PE studies WP3: Methods for signal detection WP4: New methods for data collection from consumers WP5: Benefit-risk integration and representation  two “horizontal” WPs concerned with the communication, validation and integration of the scientific work into an integrated and cohesive European activity WP7 Training & communication WPco-L: FICF, Novartis Pharma WP6 Validation studies involving an Extended Audience WPco-L: PGRx (LASER), SARD WP1 Project management & administration Coordinator: EMA Deputy Coordinator: GSK WP2 Framework for PE studies WPco-L: UU, Pfizer WP3 Methods for signal detection WPco-L: UMC, Bayer WP4 New tools for data collection WPco-L: EMA, HLU WP5 Benefit/risk integration and representation WPco-L: Imperial, ME WP6: Validation studies involving an Extended Audience WP7: Training and communication Common grounds of interest and common goals of consortium partners  Strengthen the monitoring of the safety of medicinal products  Enhance the monitoring of the benefit-risk of medicines  Better evaluate and communicate medicinal products’ benefit-risk profile throughout their lifecycle  Develop modern ways of collecting data on medication, lifestyle and risk factors directly from consumers  Enhance the early detection and assessment of adverse drug reactions

WHO ARE WE?. PROTECT is a multi-national consortium of 34 public and private partners including academics, regulators, SMEs and EFPIA companies with extensive experience in pharmacovigilance. In orer to efficiently manage the PROTECT project, the research agenda was split into 7 sub-projects – work packages (WPs) which are complemented by a multi-layer management and governance structure including Consortium Assembly, Steering Committee and external expert group (External Advisory Board). Project coordination and management consists of (Deputy) Coordinator, PROTECT Management Support Team and Managing Entity of the IMI JU funding. The relationship between individual entities is shown in the diagram below. Managing Entity of IMI JU funding Steering Committee WP1 co-leaders = Coordinator & Deputy Coordinator WP2 co-leaders WP3 co-leaders WP4 co-leaders WP5 co-leaders WP6 co-leaders WP7 co-leaders WP 1 Management & Administration = PROTECT Management Support WP 2 Framework of PE studies WP 3 Methods for SD WP 4 WP 5 New tools for B/R integration & data collection representation WP 6 Validation studies WP 7 Training & communication External Advisory Board External independent experts Consortium Assembly All participants Seven WPs are subdivided into six scientific (each addressing one of the objectives above) and one managerial packages which are distinct from one another by their specific objectives, their methodologies, the type of data they use and the required expertise, but complimentary with regard to the overall project. These WPs can be described as  • one WP concerned with the aspects of the organisation and management of PROTECT: WP1: Project management and administration  • four “vertical” WPs targeting the specific scientific objectives and methodological developments WP2: Framework for PE studies WP3: Methods for signal detection WP4: New methods for data collection from consumers WP5: Benefit-risk integration and representation  • two “horizontal” WPs concerned with the communication, validation and integration of the scientific work into an integrated and cohesive European activity WP7 Training & communication WPco-L: FICF, Novartis Pharma WP6 Validation studies involving an Extended Audience WPco-L: PGRx (LASER), SARD WP1 Project management & administration Coordinator: EMA Deputy Coordinator: GSK WP2 Framework for PE studies WPco-L: UU, Pfizer WP3 Methods for signal detection WPco-L: UMC, Bayer WP4 New tools for data collection WPco-L: EMA, HLU WP5 Benefit/risk integration and representation WPco-L: Imperial, ME WP6: Validation studies involving an Extended Audience WP7: Training and communication Common grounds of interest and common goals of consortium partners  • Strengthen the monitoring of the safety of medicinal products  • Enhance the monitoring of the benefit-risk of medicines  • Better evaluate and communicate medicinal products’ benefit-risk profile throughout their lifecycle  • Develop modern ways of collecting data on medication, lifestyle and risk factors directly from consumers  • Enhance the early detection and assessment of adverse drug reactions

WHO ARE WE?. PROTECT is a multi-national consortium of 34 public and private partners including academics, regulators, SMEs and EFPIA companies with extensive experience in pharmacovigilance. In orer order to efficiently manage the PROTECT project, the research agenda was split into 7 sub-projects – work packages (WPs) which are complemented by a multi-layer management and governance structure including Consortium Assembly, Steering Committee and external expert group (External Advisory Board). Project coordination and management consists of (Deputy) Coordinator, PROTECT Management Support Team and Managing Entity of the IMI JU funding. The relationship between individual entities is shown in the diagram below. Managing Entity of IMI JU funding Steering Committee WP1 co-leaders = Coordinator & Deputy Coordinator WP2 co-leaders WP3 co-leaders WP4 co-leaders WP5 co-leaders WP6 co-leaders WP7 co-leaders WP 1 Management & Administration = PROTECT Management Support WP 2 Framework of PE studies WP 3 Methods for SD WP 4 WP 5 New tools for B/R integration & data collection representation WP 6 Validation studies WP 7 Training & communication External Advisory Board External independent experts Consortium Assembly All participants Seven WPs are subdivided into six scientific (each addressing one of the objectives above) and one managerial packages which are distinct from one another by their specific objectives, their methodologies, the type of data they use and the required expertise, but complimentary with regard to the overall project. These WPs can be described as  one WP concerned with the aspects of the organisation and management of PROTECT: WP1: Project management and administration  four “vertical” WPs targeting the specific scientific objectives and methodological developments WP2: Framework for PE studies WP3: Methods for signal detection WP4: New methods for data collection from consumers WP5: Benefit-risk integration and representation  two “horizontal” WPs concerned with the communication, validation and integration of the scientific work into an integrated and cohesive European activity WP7 Training & communication WPco-L: FICF, Novartis Pharma WP6 Validation studies involving an Extended Audience WPco-L: PGRx (LASER), SARD WP1 Project management & administration Coordinator: EMA Deputy Coordinator: GSK WP2 Framework for PE studies WPco-L: UU, Pfizer WP3 Methods for signal detection WPco-L: UMC, Bayer WP4 New tools for data collection WPco-L: EMA, HLU WP5 Benefit/risk integration and representation WPco-L: Imperial, ME WP6: Validation studies involving an Extended Audience WP7: Training and communication Common grounds of interest and common goals of consortium partners  Strengthen the monitoring of the safety of medicinal products  Enhance the monitoring of the benefit-risk of medicines  Better evaluate and communicate medicinal products’ benefit-risk profile throughout their lifecycle  Develop modern ways of collecting data on medication, lifestyle and risk factors directly from consumers  Enhance the early detection and assessment of adverse drug reactions

WHO ARE WE?. PROTECT is a multi-national consortium of 34 public and private partners including academics, regulators, SMEs and EFPIA companies with extensive experience in pharmacovigilance. In orer order to efficiently manage the PROTECT project, the research agenda was split into 7 sub-projects – work packages (WPs) which are complemented by a multi-layer management and governance structure including Consortium Assembly, Steering Committee and external expert group (External Advisory Board). Project coordination and management consists of (Deputy) Coordinator, PROTECT Management Support Team and Managing Entity of the IMI JU funding. The relationship between individual entities is shown in the diagram below. Managing Entity of IMI JU funding Steering Committee WP1 co-leaders = Coordinator & Deputy Coordinator WP2 co-leaders WP3 co-leaders WP4 co-leaders WP5 co-leaders WP6 co-leaders WP7 co-leaders WP 1 Management & Administration = PROTECT Management Support WP 2 Framework of PE studies WP 3 Methods for SD WP 4 WP 5 New tools for B/R integration & data collection representation WP 6 Validation studies WP 7 Training & communication External Advisory Board External independent experts Consortium Assembly All participants Seven WPs are subdivided into six scientific (each addressing one of the objectives above) and one managerial packages which are distinct from one another by their specific objectives, their methodologies, the type of data they use and the required expertise, but complimentary with regard to the overall project. These WPs can be described as  • one WP concerned with the aspects of the organisation and management of PROTECT: WP1: Project management and administration  • four “vertical” WPs targeting the specific scientific objectives and methodological developments WP2: Framework for PE studies WP3: Methods for signal detection WP4: New methods for data collection from consumers WP5: Benefit-risk integration and representation  • two “horizontal” WPs concerned with the communication, validation and integration of the scientific work into an integrated and cohesive European activity WP7 Training & communication WPco-L: FICF, Novartis Pharma WP6 Validation studies involving an Extended Audience WPco-L: PGRx (LASER), SARD WP1 Project management & administration Coordinator: EMA Deputy Coordinator: GSK WP2 Framework for PE studies WPco-L: UU, Pfizer WP3 Methods for signal detection WPco-L: UMC, Bayer WP4 New tools for data collection WPco-L: EMA, HLU WP5 Benefit/risk integration and representation WPco-L: Imperial, ME WP6: Validation studies involving an Extended Audience WP7: Training and communication Common grounds of interest and common goals of consortium partners  • Strengthen the monitoring of the safety of medicinal products  • Enhance the monitoring of the benefit-risk of medicines  • Better evaluate and communicate medicinal products’ benefit-risk profile throughout their lifecycle  • Develop modern ways of collecting data on medication, lifestyle and risk factors directly from consumers  • Enhance the early detection and assessment of adverse drug reactions