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.
Visit websiteProvided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE
Services offered by EATRIS include regulatory and Health Technology Assessment (HTA) expertise
Visit websiteProvided by EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION
*The EURORDIS Open Academy brings together all EURORDIS trainings with the goal of building the capacity of rare disease patient advocates.
Through the EURORDIS Open Academy capacity-building programmes, EURORDIS empowers patient advocates to have the confidence and knowledge needed to bring their expertise to discussions on health care, research and medicines development.
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.
Services offered by EATRIS include advice on intellectual property issues and industry partnering strategy (innovation management)
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EURORDIS promotes the implementation of services adapted to the needs of people living with a rare disease and provides:
* Connect with a patient organisation
* Rare disease helplines: offer social, psychological and information solutions to people living with a rare disease.Specialised Social Services are instrumental to the empowerment of people living with rare diseases and essential to the improvement of their well-being and health.
* Find a specialised Social Service
* Medical expertise
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…)
Visit websiteProvided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE
Within the EJP RD, EATRIS offers an expert mentoring service for rare disease researchers. Advancing promising technologies and therapies towards clinical application is a complex undertaking. Academic research often lacks easy access to regulatory, therapy development expertise, manufacturing, and healthcare practice, leading to high failure rates.
The mentoring programmes provides mentoring on
* Translational feasibility
* Regulatory compliance
* Product classification
* Quality assurance and control
* Intellectual property strategy
* Suitability of analytical readouts
* Manufacturing
* Therapy development
* Quality Management (support)
The QM always works in close cooperation with all staff members to provide cellular therapeutic agents, tissues, diagnostic services and study results of the highest quality and in compliance with legal requirements, guidelines and standards. This includes – but is not restricted to – support in the following respects:
Document management (writing, approval, distribution, version control, archiving, …)
Process management (recording of process flow diagrams, assignment of responsibilities, monitoring of process indicators, process enhancement, …)
Training and further education (conduct, management and refreshment of training)
Risk assessment and performance of risk analyses
Fault and deviation management (classification, allocation, processing and closing of errors, performance of root cause analyses and implementation of improvements)
Complaint handling
Supplier qualification (obtaining certificates or quality questionnaires, approval or blocking of suppliers, …)
Approval of maintenance, calibration and qualification reports for critical equipment
Method and process validation (defining and writing validation plans, calculating and representing results, writing validation reports, …)
Recording and reporting of side effects (pharmacovigilance, tissue vigilance, medical device vigilance)
Implementation of new standards
Auditing and monitoring including their reporting
Annual reporting (product quality reports, vigilance reports, management reports, and others)
• 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)
