Expertise & support

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  2. Expertise & support
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Biosafety and biosecurity expertise

Provided by EUROPEAN RESEARCH INFRASTRUCTURE ON HIGHLY PATHOGENIC AGENTS (ERINHA)

Erinha

Access to high containment, biosafety and biosecurity expertise.
ERINHA’s senior scientists and experts in biosafety and biosecurity with long-standing experience in operating and maintaining biocontainment facilities (BSL4 and complementary) provide expertise on:
• Development of research programs on high-consequence pathogens
• Developing risk assessments
• Building and operating a high containment facility
• Designing and implementing a biosafety program
• Other expertise related to high containment research facilities

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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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Regulatory Service

Provided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE

EATRIS

Through a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of product. Our range of services include:

– Expert opinion
– Orphan Drug Designation and Scientific Advice application at the EMA
– Pre-clinical and clinical plan development
– Informal scientific advice with selected national competent authorities, for highly complex projects
– Access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.

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Training on technologies, methodological and computer skills

Provided by IFB - FRENCH INSTITUTE OF BIOINFORMATICS

france bioinformatique

IFB provides IFB users (biologists, biomedical and bioinformaticians) with a training offer that takes into account the wide diversity of needs and expectations:

– diversity of computer skills (no command line experience, occasional use, familiar, program a little)
– specific courses on new technologies or on biological applications (e.g. NGS, long reads, metabolomics…)
– generic methodological skills (statistics, good programming practices, etc.)
– advanced use of IT technologies (HPC, virtualisation, cloud computing, interoperability, FAIR practices, integrative bioinformatics…)
– good training practices (pedagogical approaches, reuse of materials, etc.)

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Expert advice service

Provided by https://conect4children.eu/

C4C 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.

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Directory of professionals and expert centers

Provided by ORPHANET

ORPHANET

Orphanet provides information on professionals whose activity(ies) in the field of rare diseases is (are) registered in Orphanet. This includes, for example, consultant and physicians in charge of an expert centre, biologists in a laboratory, researchers, representatives of patient organisations, coordinators of networks, principal investigators of clinical trials, managers or contact person of registries and biobanks, and experts writing or peer-reviewing data for Orphanet.

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Clinical Patient Management System for ERNs

Provided by Clinical Patient Management System (CPMS)

The Clinical Patient Management System (CPMS) is a secure and fully GDPR compliant IT platform aiming to facilitate the cross-border discussion of rare clinical cases.
The platform is supervised by the Directorate General for Health and Food Safety (DG SANTE) of the European Commission and funded under the EU4Health Programme.
The CPMS 2.0 is open source, distributed under the EUPL license.

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Call for cohort proposal

Provided by RARE DISEASE COHORTS (RADICO) / FRENCH NATIONAL PROGRAMME ON RARE DISEASE COHORTS

Radico

RaDiCo supports the implementation of national programs in any country that would need it, by sharing its expertise in database management and implementation of national cohorts on rare diseases. Beyond its own projects, RaDiCo promotes the commitment of French actors to European and international projects needing the implementation of borderless cohorts. We advise and support you for the setting up of propositions and for the management of your programs in this field..).

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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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Training on HTS and informatics

Provided by EU-OPENSCREEN

EU Openscreen

EU-OPENSCREEN provides training and education activities in the aread of assay development, assay technologies, instrumentation and automation, compound management, and informatics.

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