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EMA’s Innovation Task Force

Provided by European Medicines Agency

EMA

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.

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Innovation offices in national regulatory agencies

Provided by EU Innovation Offices Network

HMA INNOVATION NETWORK

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

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Comprehensive Inventory of available regulatory support

Provided by CSA STARS

CSA STARS

a Comprehensive Inventory (CI) has been developed to assist European academic drug developers in finding support on regulatory affairs. The inventory lists various support services provided by national competent authorities, public actors and private entities by:
* Expertise area (ATMP, Biologicals, biomarkers, chemicals, diagnostics, drug repurposing, drug-device combinations, e/m health, ethical aspects, IVD/ Blood products, legal matters, medical devices, paediatric studies, statistics, societal aspects)
* Support activity (assistance in clinical trial application, pre-grant advice, GCP, GLP, GMP, non clinical, pre-clinical, paediatrics, Phase I, PHase II-III, Phase IV, pre-grant advice, quality)

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Strategic Feasibility Advice Service

Provided by conect4children

Conect4Children

Strategic Feasibility Advice is the c4c term to describe the process of providing advice to bring clinical and innovative methodology expertise as well as the patient and parent perspective to paediatric development.
The aim is to expedite the development of high quality paediatric plans/protocols and conduct of feasible paediatric clinical trials and by this the access to well-studied drugs for paediatric patients.

This service provides the industry and academic c4c beneficiaries the opportunity to gain advice on any aspect of paediatric drug development throughout the entire cycle.

The service aims to assist sponsors in new ways to overcome the hurdles of paediatric drug development and to ensure that the study design is patient centred.

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Brokerage service Connection application

Provided by SOLVE-RD

Rare Diseases Models & Mechanisms – Europe (RDMM-Europe): This brokerage service will catalyse connections between people discovering new genes in rare disease patients and basic scientists who can study those genes and pathways in model organisms. Solve-RD brokerage service are to:
*provide functional validation of human genetic variants that cause disease;
*supplement clinical disease gene discoveries by generating functional data so as to get higher impact publications;
*develop insights into potential rationale for treatment (e.g. identification of candidate drug targets) via knowledge of a disease gene pathway; and
*establish longer term collaborations between basic scientists and clinicians that will lead to subsequent grant funding in support of outstanding basic and/or applied research

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Clinical Patient Management System for ERNs

Provided by Clinical Patient Management System (CPMS)

Clinical Patient Management System (CPMS) is a secure IT-Platform used by clinicians across Europe to discuss patient cases without the patients having to travel. The ERN Experts (from one or more ERNs) gather in multidisciplinary panels and use CPMS to carry out e-consultations of rare and complex cases. Patient medical documents can be safely uploaded to the CPMS after a consent form has been signed by the patient.
Integrated tools in CPMS allow peer-to-peer communication, viewing of digital documents and recording expert contributions. This promotes an active collaboration, sharing knowledge and experience within and across ERNs. The health professionals are ultimately aiming an outcome either as a diagnosis, treatment, clinical trial or other.

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Clinical Research Metadata Repository

Provided by EOSC-Life

EOSC Life

Clinical Research Metadata Repository (including COVID-19 data), allowing researchers to access clinical studies and related data objects. These include, for example, protocols, information sheets and consent forms, data management plans, statistical analysis plans, case report forms, results, publications, descriptive metadata, etc. MDR contributes to making clinical research data from all disease areas FAIR by increasing data Findability. Browse and search metadata on clinical trials—as well as all related documents
FAIRsharing.org (standards, databases, policies) is a place to discover standards, repositories and data policies and how they interlink. It also features a prototype educational page on standards. The resource serves all disciplines and has been adopted by funders, publishers, RDA and other organisations.

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Brain research clusters promoting co-operation and exchange

Provided by EPiCLUSTER

EBRA

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.

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Europe-wide collaborative network on rare neurodevelopmental disorders

Provided by MINDDS

MINDDS

MINDDS will achieve its objectives by:

Design and develop of an approach for transnational patient recruitment, incorporating regulatory, legal and ethical requirements. These will include protocols for new clinical assessment, patient registration and data deposition.
Standardization of protocols and methodologies to maximize the utility
and quality of the resultant research data outputs. Standardized research protocols will encompass the major study regimes, including clinical phenotyping, brain imaging and patient-derived cell studies.
Delivery of data integration and sharing via linkage to relevant data platforms, supporting informatics protocols to enhance NDD patient research.
Place the study of rare NDD patients in the context of other neuroscience research by promoting a Convergent Neuroscience approach.
An education programme for enhanced training and knowledge exchange including research conferences, training schools and workshops.
Creation of standardized protocols, experimental methodologies and best practice for NDD research.
Knowledge exchange via its “Knowledge Nexus” to collate and share our expanding knowledge with researchers, clinicians and patients.

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CATRIS – Catalogue of Research Infrastructures services

Provided by CatRIS

CATRIS

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)

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