Managing cross-functional projects including:
Elaboration of non-clinical development plans in accordance with current regulations;
Coordination of the various stages of preclinical development with respect to timelines;
Identification of suppliers and the role of interface;
Establishment of budgets and allocation of resources.
Clinical development and regulatory affairs: highly specialized expertise and experience for the conception, preparation and realization of clinical trials, in collaboration with hospital-based investigators, and conform to both French and international regulatory frameworks.
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The Institute of Biotherapies is developing a partnership and valorization strategy which will allow it to take advantage of opportunities for co-development and co-exploitation.
Thus it has the following expertise which allow it to implement:
* An in-licensing strategy for technologies, savoir-faire and patents necessary for the development of projects for the Institute of Biotherapies;
* An out-licensing strategy for projects and technologies developed within the Institute of Biotherapies;
* A scientific and juridical expertise;
* An expertise towards transverse projects;
* A strategy for the development of international collaborations.
Provided by EUROPEAN CLINICAL RESEARCH INFRASTRUCTURES NETWORK (ECRIN)
• information and advice for funding applications and preparation of multinational clinical trials (methodology, operational aspects, regulatory, ethics, contracting…)
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• trial management operations (interaction with competent authorities & ethics committees, project management, monitoring, vigilance, data management)
• clinical trial tools (outcome measures, regulatory database, site locations, risk-based monitoring)
• data centre certification program (audits European, non-commercial data centres using ECRIN IT/DM standards, to confirm their ability to provide compliant, effective, and efficient data management services for controlled clinical trials)
Visit websiteProvided by EUROPEAN RESEARCH INFRASTRUCTURE ON HIGHLY PATHOGENIC AGENTS (ERINHA)
To facilitate Transnational access (TNA) to ERINHA’s member facilities, ERINHA periodically opens a call for applications. Free of charge TNA includes administrative & logistical support, remote use of ERINHA high containment facilities, and technical & scientific support.
Transnational Access is either:
– In person/on-site, and provided to selected Users that visit the facilities, on the necessary conditions that the users have appropriate background and successfully complete the required training
– Remote, through the provision of remote scientific services to selected Users
Note: Remote access will systematically apply for in vivo experiments
Provided by EUROPEAN RESEARCH INFRASTRUCTURE ON HIGHLY PATHOGENIC AGENTS (ERINHA)
ERINHA offers training for:
* Working safely in high containment laboratories
* General Biosecurity Training
* Operations of a Biosafety Laboratory
* Other trainings related to high containment research facilities
Provided by EUROPEAN RESEARCH INFRASTRUCTURE ON HIGHLY PATHOGENIC AGENTS (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
Provided by IFB - FRENCH INSTITUTE OF BIOINFORMATICS
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.)
