Ceiling Increase — Efficacy and Safety studies on Medicines

Contract Value:: EUR 8M - 8M
Notice Type:: Contract award notice

Published Date:: 21 December 2020
Closing Date:

Location(s):: NL1 NOORD-NEDERLAND (NL Netherlands/NEDERLAND)

Description:

The purpose of this procurement procedure is to increase the ceiling of multiple framework contracts with reopening of competition in 4 different lots awarded following open procedure EMA/2017/09/PE.

The subject of the framework contract are post-authorisation effectiveness and pharmacoepidemiology studies to generate data and information to support regulatory decision-making. Research may also focus on the effectiveness of regulatory measures taken and on the impact of relevant legislation. The range of research topics is limited to those with high public health relevance and with a European impact. The scope of the funding covers both nationally and centrally authorised products, including vaccines. The results obtained from this research will subsequently be assessed by the responsible Agency Committee regarding the need for regulatory action and further research may subsequently also be conducted to measure the effectiveness of regulatory actions taken.

Use of Innovative Methods to Optimise the Utility of Sparse Data to Support Benefit/Risk Assessment

For full description please see section 3.2 of the technical specifications (procurement documents).

Qualitative Research

For full description please see section 3.2 of the technical specifications (procurement documents).

Pharmacoepidemiology Research – Rapid Descriptive Studies

For full description please see section 3.2 of the technical specifications (procurement documents).

Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research

For full description please see section 3.2 of the technical specifications (procurement documents).

Awarded to:: Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; Aarhus University Hospital, Department of Clinical Epidemiology, Aarhus (DK); Aarhus University Hospital, Department of Clinical Epidemiology, Aarhus (DK); Aarhus University Hospital, Department of Clinical Epidemiology, Aarhus (DK); Aarhus University Hospital, Department of Clinical Epidemiology, Aarhus (DK); Aarhus University Hospital, Department of Clinical Epidemiology, Aarhus (DK); Aarhus University Hospital, Department of Clinical Epidemiology, Aarhus (DK); Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Qualitative Research; Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Pharmacoepidemiology Research – Rapid Descriptive Studies; Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid (ES); Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology, Rome (IT); Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology, Rome (IT); Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology, Rome (IT); Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology, Rome (IT); Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology, Rome (IT); Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology, Rome (IT); Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara, Ferrara (IT); Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara, Ferrara (IT); Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara, Ferrara (IT); Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara, Ferrara (IT); Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara, Ferrara (IT); Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara, Ferrara (IT); Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Qualitative Research; Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Pharmacoepidemiology Research – Rapid Descriptive Studies; Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; Dpt. Biomedical, Dental Sciences, Morphofunctional Imaging (BIOMORF) University Messina, Messina (IT); Pharmacoepidemiology Research – Rapid Descriptive Studies; Erasmus University Medical Center, Rotterdam (NL); Erasmus University Medical Center, Rotterdam (NL); Erasmus University Medical Center, Rotterdam (NL); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Qualitative Research; Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Pharmacoepidemiology Research – Rapid Descriptive Studies; Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; Fundació Institut Català de Farmacologia (FICF), Barcelona (ES); Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana, Valencia (ES); Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana, Valencia (ES); Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana, Valencia (ES); Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana, Valencia (ES); Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana, Valencia (ES); Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana, Valencia (ES); Use of Innovative Methods to Optimise the Utility of Sparse Data to Support Benefit/Risk Assessment; Hasselt University, Hasselt (BE); Use of Innovative Methods to Optimise the Utility of Sparse data to Support Benefit/Risk Assessment; Hasselt University, Hasselt (BE); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; Hospital Lillebaelt, Region Syddanmark, Vejle (DK); Hospital Lillebaelt, Region Syddanmark, Vejle (DK); Hospital Lillebaelt, Region Syddanmark, Vejle (DK); Hospital Lillebaelt, Region Syddanmark, Vejle (DK); Hospital Lillebaelt, Region Syddanmark, Vejle (DK); Hospital Lillebaelt, Region Syddanmark, Vejle (DK); Qualitative Research; Icon Clinical Research Ltd, Dublin (IE); Icon Clinical Research Ltd, Dublin (IE); Icon Clinical Research Ltd, Dublin (IE); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; IQVIA Ltd, Reading (UK); IQVIA Ltd, Reading (UK); IQVIA Ltd, Reading (UK); IQVIA Ltd, Reading (UK); IQVIA Ltd, Reading (UK); Qualitative Research; IQVIA Ltd, Reading (UK); IQVIA Ltd, Reading (UK); IQVIA Ltd, Reading (UK); Pharmacoepidemiology Research – Rapid Descriptive Studies; IQVIA Ltd, Reading (UK); IQVIA Ltd, Reading (UK); IQVIA Ltd, Reading (UK); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; IQVIA Ltd, Reading (UK); Use of Innovative Methods to Optimise the Utility of Sparse Data to Support Benefit/Risk Assessment; Katholieke Universiteit Leuven, Leuven (BE); Use of Innovative Methods to Optimise the Utility of Sparse data to Support Benefit/Risk Assessment; Katholieke Universiteit Leuven, Leuven (BE); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; London School of Hygiene and Tropical Medicine (LSHTM), London (UK); London School of Hygiene and Tropical Medicine (LSHTM), London (UK); London School of Hygiene and Tropical Medicine (LSHTM), London (UK); London School of Hygiene and Tropical Medicine (LSHTM), London (UK); London School of Hygiene and Tropical Medicine (LSHTM), London (UK); Qualitative Research; London School of Hygiene and Tropical Medicine (LSHTM), London (UK); London School of Hygiene and Tropical Medicine (LSHTM), London (UK); London School of Hygiene and Tropical Medicine (LSHTM), London (UK); Pharmacoepidemiology Research – Rapid Descriptive Studies; London School of Hygiene and Tropical Medicine (LSHTM), London (UK); London School of Hygiene and Tropical Medicine (LSHTM), London (UK); London School of Hygiene and Tropical Medicine (LSHTM), London (UK); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; London School of Hygiene and Tropical Medicine (LSHTM), London (UK); Otto-von-Guericke-Universitaet Magdeburg, Medical Faculty, Magdeburg (DE); Otto-von-Guericke-Universitaet Magdeburg, Medical Faculty, Magdeburg (DE); Otto-von-Guericke-Universitaet Magdeburg, Medical Faculty, Magdeburg (DE); Otto-von-Guericke-Universitaet Magdeburg, Medical Faculty, Magdeburg (DE); Otto-von-Guericke-Universitaet Magdeburg, Medical Faculty, Magdeburg (DE); Otto-von-Guericke-Universitaet Magdeburg, Medical Faculty, Magdeburg (DE); RTI Health Solutions, Barcelona (ES); RTI Health Solutions, Barcelona (ES); RTI Health Solutions, Barcelona (ES); RTI Health Solutions, Barcelona (ES); RTI Health Solutions, Barcelona (ES); RTI Health Solutions, Barcelona (ES); Stichting ENTIS (European Network Teratology Information Services) Foundation, s'-Hertogenbosch (NL); Stichting ENTIS (European Network Teratology Information Services) Foundation, s'-Hertogenbosch (NL); Stichting ENTIS (European Network Teratology Information Services) Foundation, s'-Hertogenbosch (NL); Stichting ENTIS (European Network Teratology Information Services) Foundation, s'-Hertogenbosch (NL); Stichting ENTIS (European Network Teratology Information Services) Foundation, s'-Hertogenbosch (NL); Stichting ENTIS (European Network Teratology Information Services) Foundation, s'-Hertogenbosch (NL); Swansea University, Swansea (UK); Swansea University, Swansea (UK); Swansea University, Swansea (UK); Swansea University, Swansea (UK); Swansea University, Swansea (UK); Swansea University, Swansea (UK); Universiteit Utrecht, Utrecht (NL); Universiteit Utrecht, Utrecht (NL); Universiteit Utrecht, Utrecht (NL); Universiteit Utrecht, Utrecht (NL); Universiteit Utrecht, Utrecht (NL); Qualitative Research; Universiteit Utrecht, Utrecht (NL); Universiteit Utrecht, Utrecht (NL); Universiteit Utrecht, Utrecht (NL); Pharmacoepidemiology Research – Rapid Descriptive Studies; Universiteit Utrecht, Utrecht (NL); Universiteit Utrecht, Utrecht (NL); Universiteit Utrecht, Utrecht (NL); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; Universiteit Utrecht, Utrecht (NL); University Hospital Center of Toulouse, Toulouse (FR); University Hospital Center of Toulouse, Toulouse (FR); University Hospital Center of Toulouse, Toulouse (FR); University Hospital Center of Toulouse, Toulouse (FR); University Hospital Center of Toulouse, Toulouse (FR); University Hospital Center of Toulouse, Toulouse (FR); University Medical Center Utrecht, Utrecht (NL); University Medical Center Utrecht, Utrecht (NL); University Medical Center Utrecht, Utrecht (NL); University Medical Center Utrecht, Utrecht (NL); University Medical Center Utrecht, Utrecht (NL); Qualitative Research; University Medical Center Utrecht, Utrecht (NL); University Medical Center Utrecht, Utrecht (NL); University Medical Center Utrecht, Utrecht (NL); Pharmacoepidemiology Research – Rapid Descriptive Studies; University Medical Center Utrecht, Utrecht (NL); University Medical Center Utrecht, Utrecht (NL); University Medical Center Utrecht, Utrecht (NL); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; University Medical Center Utrecht, Utrecht (NL); University of Bath, Bath (UK); University of Bath, Bath (UK); University of Bath, Bath (UK); University of Bath, Bath (UK); University of Bath, Bath (UK); University of Bath, Bath (UK); Use of Innovative Methods to Optimise the Utility of Sparse Data to Support Benefit/Risk Assessment; University of Dundee, Dundee (UK); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; University of Dundee, Dundee (UK); University of Dundee, Dundee (UK); University of Dundee, Dundee (UK); University of Dundee, Dundee (UK); University of Dundee, Dundee (UK); Use of Innovative Methods to Optimise the Utility of Sparse data to Support Benefit/Risk Assessment; University of Dundee, Dundee (UK); Pharmacoepidemiology Research – Association Studies, including Pregnancy and Breastfeeding Research; University of Dundee, Dundee (UK); University of Ulster, Coleraine (UK); University of Ulster, Coleraine (UK); University of Ulster, Coleraine (UK); University of Ulster, Coleraine (UK); University of Ulster, Coleraine (UK); University of Ulster, Coleraine (UK)

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The Buyer:: European Medicines Agency

CPV Code(s):: 73000000 - Research and development services and related consultancy services; 73210000 - Research consultancy services