The European COVID-19 Data Platform consists of three connected components:
1. SARS-CoV-2 Data Hubs, which organise the flow of SARS-CoV-2 outbreak sequence data and provide comprehensive open data sharing for the European and global research communities.
2. Federated European Genome-phenome Archive, which provides secure controlled access sharing of sensitive patient and research subject data sets relating to COVID-19.
3. COVID-19 Data Portal, which brings together and continuously update relevant COVID-19 datasets and tools, will host sequence data sharing and will facilitate access to other SARS-CoV-2 resources.
EU
One of the main aims of EBRA is to facilitate the emergence of research projects in specific areas in active clusters and therefore EBRA supports carefully selected clusters. An EBRA cluster is understood as a research community that can be directed towards basic research, clinical research and/or methodological approaches under a common topic and disease area within brain research. EBRA clusters promote co-operation and exchange between brain research projects and networks. The clusters organise activities with the aim to promote external collaborations, foster the exploitation of results, address data sharing issues and foster access to research infrastructures.
Visit website
CatRIS is an open, trusted and user-friendly portal to a harmonised and aggregated catalogue of services and resources provided by Research Infrastructures (RI) and Core Facilities (CF) across Europe. Ithas a section devoted to Medical & Health Sciences services, in the areas of Basic Medicine (1), Clinical Medicine (7), Health Sciences (29) and Medical Biotechnology (11)
Visit websiteHMA-EMA RWD Catalogues
Provided by European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCepp)
The HMA-EMA RWD Catalogues are repositories of metadata collected from real-world data (RWD) sources and RWD studies. They are intended to help regulators, pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.
The Catalogue of RWD sources replaced the ENCePP Resources Database, while the Catalogue of RWD studies replaced the EU PAS Register®. Additionally, Catalogues of institutions and networks are also available to support the RWD sources and RWD studies Catalogues. Together, these Catalogues offer an improved and more efficient service for researchers, regulators, and pharmaceutical companies to:
Facilitate the discoverability of adequate data sources to generate real-world evidence for regulatory purposes (e.g., identification of RWD data sources suitable for investigating a specific research question);
Aid in the suitability assessment of data sources by providing clear and easy access to information from the study protocol and study report;
Improve interoperability between studies and data sources;
Improve transparency.
Joint Clinical Assessment (JCA) and Scientific Consultations (JSC)
Provided by European Network for Health Technology Assessment (EUNetHTA)
EUnetHTA develops several services that help inform the decision-making process around the introduction of pharmaceuticals and other technologies at the national, regional and European levels. These include Joint assessments, early diologues and Post Launch Evidence Generation (PLEG)
* Assessment submission: Health technology companies are encouraged to contact us via the following two channels if interested in a EUnetHTA assessment of their product. These are distinguished by EUnetHTA as Pharmaceuticals and Other Technologies (i.e. non-pharmaceuticals).
*Early dialogue: parallel scientific advice with the European Medicines Agency. This aims to allow medicine developers to obtain feedback from regulators and health technology assessment (HTA) bodies on their evidence-generation plans to support decision-making on marketing authorisation and reimbursement of new medicines at the same time.
* Horizon Scanning: topic identificatin, selection and Prioritisation for HTA cooperation
Guide on patient partnerships in rare diseases research projects
Provided by European Joint Programme on Rare Diseases (EJP RD)
The EJP RD has developed a short guide on patient partnerships in rare diseases research projects. It aims to encourage fruitful, sustainable and enduring partnerships between scientists and patient organisations, co-leading the way for systematic patient-centered research.
Visit websiteTraining and capacity buildling of the rare disease research and care community
Provided by European Joint Programme on Rare Diseases (EJP RD)
The EJP RD Training and Empowerment program aims to develop knowledge and build capacity of the rare disease (RD) research and care community through the delivery of training programs on a wide range of relevant topics thereby providing opportunities to a large panel of stakeholders.
Visit website
The Innovation Task Force (ITF) is a multidisciplinary group that includes scientific, regulatory and legal competences. It was set up to ensure coordination across the Agency and to provide a forum for early dialogue with applicants on innovative aspects in medicines development.
The objectives of the ITF are to:
* Establish a discussion platform for early dialogue with applicants, in particular micro, small and medium-sized enterprises (SMEs), academics and researchers, to proactively identify scientific, legal and regulatory issues of emerging therapies and technologies;
* Address the impact of emerging therapies and technologies on current scientific, legal and regulatory requirements with the Agency’s committees and their working parties;
* Identify the need for specialised expertise at an early stage;
* Provide advice on the eligibility to Agency procedures relating to research and development, in conjunction with the Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP), the European Commission and national competent authorities (NCAs) as appropriate.
National scientific advice for developers of medicinal products or medical devices and other technologies to optimize prospectively their development programme. • Two in one approach = get two NCA opinions within one application
Visit websiteC4C Expert Advice service gives you fast and efficient access to over 400 clinical, methodology, and patient and public involvement experts.
Their up-to-date and in-depth insights can provide value at any stage of paediatric drug development but are especially useful to improve study design.
We provide end-to-end support, resulting in high-quality, independent advice reports that can be used in regulatory discussions on PIPs (paediatric investigation plans) and PSPs (paediatric study plans )
Obtain multidisciplinary insights from a single request and a single contract.
A tailored team of experts is assembled for each request.
Improve patient recruitment and retention through making a study more patient-centric based on the insights of children, young people and families.
