An exploratory analysis on the involvement of European organisations in the field of biomedical innovation
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24 octobre 2023
- handle: 10670/1.bjy4qx
- halshs: halshs-04290569
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Therapy, Cellular Cells--Therapeutic use Cell therapyCiter ce document
Anaëlle Scheer et al., « An exploratory analysis on the involvement of European organisations in the field of biomedical innovation », HAL-SHS : droit et gestion, ID : 10670/1.bjy4qx
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Many actors influence the framing of EU legislation and regulation applicable to gene and cell therapy. Nevertheless, one can wonder how much their activity is focusing on gene and cell therapy or whether it is part of a wider set of activities taking place in the more general theme of biomedical innovation. From an identification of the actors involved in the public consultation process of adoption of Regulations on Advanced Therapy Medicinal Products, on substances of human origin, and of guidance applicable to ATMPs, a few of them have been selected in order to conduct more specific analysis. Our selection process for this pilot analysis included the following criteria: European level organisation, degree of the involvement in the above-mentioned consultation processes, combination between organisations the names of which imply either a very specific or a general remit. Another choice has been to include European organisations particularly relevant for pharmacists, as professionals involved all along the medicinal products’ life cycle. It resulted in a set of 13 European organisations: 5 business associations (Medtech Europe, European Federation of Pharmaceutical Industries and Associations, European Biopharmaceutical Enterprises, European Associations for Bioindustries, European Confederation of Pharmaceutical Entrepreneurs), 2 professional organisations (European Industrial Pharmacists Group, European Association of Hospital Pharmacists), 4 learned societies (European Society of Gene and Cell Therapy, European Society for Blood and Bone Marrow Transplantation, European Eye Bank Association, European Association of Tissue Banks, European Association of Hospital Pharmacists), 1 research institution taking the form of European project (European Network for the Advancement of Clinical Gene Transfer & Therapy), 1 European network based on national medicines agencies (EU innovation network). Then, in depth research has been conducted on the website of each organisation in order to identify their activity within and beyond gene and cell therapy regarding biomedical innovation in general. On the one hand, this poster highlights the main results concerning their organization: especially structure, governance, potential change of name or merger over time, as well as specific or general working committees. On the second hand, their fields of activity are described following an analysis based on a set of keywords. Whereas some keywords are heavily used by all organisations (gene therapy, cell therapy for example), others are more specific (orphan medicine) and others very rare (organoid).