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The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France. [ABSTRACT FROM AUTHOR]

In France, hospital cell therapy units have not been authorised to routinely produce chimeric antigen receptor T lymphocytes (CAR-T cells), which would then be referred to as academic CAR-T cells. CAR-T cells are classified as advanced therapy medicinal products and correspond to genetically modified T lymphocytes ex vivo. The CAR-T cell production process is complex and requires scientific and technical expertise to meet the acceptance criteria of the pharmaceutical quality system. The most commonly used method for genetically modifying T lymphocytes is viral transduction (lentiviral or retroviral), which requires prior access to a batch of good manufacturing practice (GMP) grade viral vector. Because of its cost, this reagent is the main limiting factor for developing CAR-T cells. A CAR-T cell produced by an industrial company is expensive (around €350,000 per injection) and the time taken by the manufacturer to make it available to the clinician can vary from three to five weeks. By meeting the economic and ecological challenges, can academic structures improve access to CAR-T cells? In this article, we present the elements necessary for the feasibility of setting up CAR-T cell production in an academic structure., (Copyright © 2023 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Copyright of Management international / International Management / Gestiòn Internacional is the property of Management International and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Management international / International Management / Gestiòn Internacional is the property of Management International and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Néphrologie & Thérapeutique is the property of John Libbey Eurotext Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Revue d'Économie Régionale & urbaine is the property of Librairie Armand Colin and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of IRBM is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Bioethics is a relatively new endeavor, emerging as a discourse distinct from considerations of moral responsibility occurring within the professions of medicine and science. This article uses the 'de-centered comparative method' to examine how the emergence and development of bioethics varies across different social and cultural settings. In particular, the article looks at bioethical work in the US and France, exploring these different manifestations of the movement toward external oversight of those working in medicine and the life sciences. Our comparative data demonstrate how pathways of professionalization are shaped by contingent cultural and historical factors. We contrast 'demand' and 'supply' theories of professionalization and suggest that the increasing prominence of the bioethical occupation is the result of both the professional desires of bioethicists and a concern for the public good. [ABSTRACT FROM AUTHOR]

Copyright of Revue d'Économie Régionale & urbaine is the property of Librairie Armand Colin and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract: In medicine, as in oncological radiotherapy, as elsewhere, the precept of quality has no meaning if it is not defined. In France as everywhere radiotherapy has its forces and its weaknesses. As in every country, its future seems assured by its character cost effective as by its capacity to make progress in the triple point of view of its equipment, its professions and its organization. However, the French radiotherapy is in crisis. The professionals saw clearly. For more than 10 years they had recalled the medical authorities to their responsibilities concerning the demographic trends for the radiotherapists and the physicists, the renovation of the equipment, the modernization of the organizations, the promotion of the evaluation of procedures and outcomes and the development of a greater fairness in the financings. But the delay taken, the setting under pressure of the professionals by the State, its services, its agencies and the media following the recent accidents cause numerous perverse effects and worried the staff. The accident of Épinal was the starting fact of an effort of professionalisation of the risk management, but also of a disturbed period favourable with a certain confusion of minds, discouragement and protective behaviors. The risks felt by the professionals then seem especially to come from the authorities and the media. It appears that the topic of quality is at the center of all these speeches. Under this vocable, it is in fact the respect of the procedures related to the requirement of security which is privileged by the State and its representatives. The apparent security seems to override the real quality of the practices. Thus, time came for a clarification of the quality and security concepts, of organizations which contribute to it and for the development of a clear strategy bringing together the interprofessionnal actors. In this context, the implication of the College and especially of the Société française de radiothérapie oncologique is a requirement. [Copyright &y& Elsevier]

Copyright of IBS, Immuno-analyse & Biologie Specialisee is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

For the National Association of Paramedic School Directors, it is necessary to have reliable data in order to participate in the development of public health policies, but also to demonstrate the importance of investing in primary care through nursing leadership, training and competence in the service of populations. In France, nursing training capacities are increasing, university recognition is underway, and efforts have been made to finance training and increase salaries. These orientations need to be strengthened at the risk of not guaranteeing the stability of the workforce in the care sector., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Radiotherapy alone or in association with systemic treatment plays a major role in the treatment of head and neck tumours, either as a primary treatment or as a postoperative modality. The management of these tumours is multidisciplinary, requiring particular care at every treatment step. We present the update of the recommendations of the French Society of Radiation Oncology on the radiotherapy of head and neck tumours from the imaging work-up needed for optimal selection of treatment volume, to optimization of the dose distribution and delivery., (Copyright © 2021 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.)

We present an update of the French society of oncological radiotherapy recommendation regarding indication, doses, and technique of radiotherapy for intrathoracic metastases. The recommendations for delineation of the target volumes and critical organs are detailed., (Copyright © 2021 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.)

The usefulness and efficiency of intensive care units have been widely highlighted in recent months. The regulatory provisions that structure and frame their organisation and operation have contributed to this. But they must evolve and be accompanied by other improvement actions, to make up for the delays and insufficiencies revealed or exacerbated by the pandemic., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

Objectives: The existence of borderline products between the status of a medicinal product and other less regulated products allows some products to have different statuses or even to change from one status to another. In order to quantify these changes, a review of medicines that have changed from drug status to other statuses (medical device, cosmetic product or food supplement) in France between 2010 and 2019 was performed., Method: The lists of medicinal products with archived or revoked marketing authorization (MA) from the French National Authority's Register of Medicinal Products were analyzed in order to identify the medicinal products withdrawn from the market between January 1, 2010 and September 30, 2019 that could be considered as products with a "potential for status change". Then, we searched on the official websites of the MA holders and other firms, for a possible return to the market with a different status, marketed by the same firm (self-change of status) or a different firm (hetero-change of status)., Results: Out of a list of 206 drugs identified as "with potential for status change", we detected a total of 101 status changes, including 36 auto-changes and 65 hetero-changes. These changes mainly concern vitamin or herbal drugs later marketed as food supplements (30 cases of auto-changes and 60 cases of hetero-changes). There are also 6 cases of switching to cosmetic product and 5 cases of switching to medical device., Conclusion: The existence of no clear distinction between the different statuses of health products facilitates their status changes. The increasing shift from "medicines" to less regulated products, the trivialization of their use by the public and their increasing consumption make them a fundamental issue of social pharmacology, requiring to raise the awareness of consumers and health professionals., (Copyright © 2020 Société française de pharmacologie et de thérapeutique. All rights reserved.)

Since 2004, procedures which can be carried out by nurses have no longer been subjet to a single global decree and now feature in different legislative and/or regulatory articles. Since 2006, several laws and decrees have expanded the scope of nursing practice, but the lists of authorised procedures for a large part of the profession have not been updated, except for theatre nurses and nurse anaesthetists. The obsolescence of these regulatory lists is out of step with the technical evolution of care, the organisation of the health system and patients' needs., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

In France, clinical research involving human beings is regulated by the Jardé's law since November 2016. The law distinguishes interventional and non-interventional studies. Both need to be authorized by a Persons Protection Committee. Studies performed on medical data collected during standard clinical care are not considered as studies involving human beings. Medical data are personal data. French Data Protection Authority National has an important role, guarantying the respect of regulation on personal data. We summarize in this article the different types of studies and the role of regulatory authorities., (Copyright © 2019 Société Nationale Française de Médecine Interne (SNFMI). Published by Elsevier Masson SAS. All rights reserved.)

Regulatory Framework for Car-T Cells: HOW CAN FRENCH HEALTHCARE PROVIDERS ADAPT THEIR ORGANIZATION TO REQUIREMENTS FOR MANUFACTURING AND DELIVERY OF THESE INNOVATIVE CELL-BASED MEDICINAL PRODUCTS?: More than five years after the first US publications reporting a significant rate of clinical responses in patients with high-risk or advanced CD19+ lymphoid malignancies, access to treatment with CAR-T Cells at European hospitals in general and at French hospitals in particular remains limited. One - and not the least - hurdle lay in the need to set up a complex and unprecedented organization that complies with European regulations on Advanced Therapy Medicinal Products as well as with national (French) regulations. We here review the organizational framework for two situations: delivery and administration of industry-manufactured CAR-T Cells as well as engineering and distribution of CAR-T Cells produced as investigational drugs to be evaluated in the context of clinical research protocols. Cet article fait partie du numéro supplément Les cellules CAR-T : une révolution thérapeutique ? réalisé avec le soutien institutionnel des partenaires Gilead : Kite et Celgene., (© 2018 Société Française du Cancer. Publié par Elsevier Masson SAS. Tous droits réservés.)

Indications of treatment by stereotactic body radiotherapy are dramatically increasing due to new potential indications. The conditions associated with the treatment delivery are multiple. The first step of the process is crucial. It is related to the validation of the indication proposed during the multidisciplinary meeting as regard the evidence-based proof of the concept. These emerging techniques mainly extracranial stereotactic body irradiation do not benefit from long-term evaluation in terms of efficiency as well as normal tissue late toxicities. Priority should be given to prospective independent clinical trials, validated by an independent scientific committee, performed under a relevant and well dedicated multicentric quality assurance program aiming to improve knowledge and selection of indications. The SFRO is still working with others professionals on the definition of the conditions for the implementation of such treatments and actively collaborates with the authorities to define the appropriate conditions to preserve the quality of the treatment delivery under these specific conditions., (Copyright © 2014 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.)