
Aurélie Mahalatchimy
Présentation
Aurélie Mahalatchimy is an academic lawyer (PhD in law from the University of Toulouse, France). She is permanent Researcher at the French National Centre for Scientific Research (CNRS, chargée de recherche), Aix Marseille University, Toulon University, Pau & Pays AdourUniversity, International, Comparative and European laws (DICE- CERIC) research lab, Aix-en-Provence, France. She is also Associated researcher to the Centre for Global Health Policy, School of Global Studies, University of Sussex, UK.
Aurélie’smain research interest is International, European and Comparative law of biomedical innovations, especially the uses of human genes, cells and tissues for therapeutic (advanced therapy medicinal products), scientific, commercial and industrial purposes.
She has been involved in various International, European, French and UK research projects. She published 52 articles, including 23 in peer-reviewed journals, co-coordinated a special issue of the French review Quaderni on Human as therapeutics, and presented 50 communications, including 13 as invited speaker.
Publications
Publications
Transhumanisme : de nouveaux droits ?DICE Éditions. DICE Éditions, 22, pp.281, 2024, Confluence des droits, DICE Editions, 979-10-97578-23-7. ⟨10.4000/11zci⟩
Ouvrages
halshs-04669903
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Propos introductifsDICE Éditions. Transhumanisme : de nouveaux droits ?, 22, DICE Éditions, pp.15-31, 2024, Confluence des droits, 979-10-97578-23-7. ⟨10.4000/11zbz⟩
Chapitre d'ouvrage
halshs-04669900
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Du transhumain au posthumain : quels droits fondamentaux ?DICE Éditions. Transhumanisme : de nouveaux droits ?, 22, DICE Éditions, pp.103-124, 2024, Confluence des droits, 979-10-97578-23-7. ⟨10.4000/11zc5⟩
Chapitre d'ouvrage
halshs-04669901
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Les droits fondamentaux comme frontières de la médecine améliorative de l'humain : l'application du principe d'égalitéAmandine Cayol; Bénédicte Bévière-Boyer; Wei Wang; Emilie Gaillard. Le transhumanisme à l'ère de la médecine améliorative, mare & martin, pp.309-329, 2024, Collection de la Chaire d’excellence CNRS : Normandie pour la Paix, 978-2-84934-832-1
Chapitre d'ouvrage
halshs-04472769
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Regulation of Genome Editing in Human iPS Cells: FranceHans-Georg Dederer; Gregor Frenken. Genome Editing in Human iPS Cells: A Comparative Legal Analysis of National Regulatory Frameworks for iPSC-based Cell/Gene Therapies, Springer, pp.83-106, 2022, 978-3-030-93022-6. ⟨10.1007/978-3-030-93023-3_4⟩
Chapitre d'ouvrage
istex
halshs-03779346
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Regulating Medicines in the European UnionThe Oxford Handbook of Comparative Health Law Edited by David Orentlicher and Tamara Hervey, Oxford University Press, 2020, ⟨10.1093/oxfordhb/9780190846756.013.24⟩
Chapitre d'ouvrage
halshs-02943155
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Le génome humain édité : risques et gouvernanceN. De Grove-Valdeyron (dir.), Innovation et Analyse des risques dans le domaine de la santé et des produits de santé dans l'Union Européenne : regards croisés, 2020
Chapitre d'ouvrage
halshs-03044087
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Introduction to Medical Products LawThe Oxford Handbook of Comparative Health Law Edited by David Orentlicher and Tamara Hervey, Oxford University Press, 2020, ⟨10.1093/oxfordhb/9780190846756.013.57⟩
Chapitre d'ouvrage
halshs-02943126
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Regulating Medical Devices in the European UnionThe Oxford Handbook of Comparative Health Law Edited by David Orentlicher and Tamara Hervey, Oxford University Press, 2020, ⟨10.1093/oxfordhb/9780190846756.013.58⟩
Chapitre d'ouvrage
halshs-02943145
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Ethical and legal frameworks for embryonic stem-cell based research in France and in Europe: a challenge for biotechnologyCUPL. Biotechnology Medicine and Law, 2018, 978-7-5620-8420-4
Chapitre d'ouvrage
halshs-01938427
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In need for a modern Daedalus? The challenging regulatory path for marketing gene therapy medicinal products in China and EuropeQ. Yanping, A.-M. Duguet. Biotechnology Medicine and Law, China University of Political Science and Law Press, 2018, 978-7-5620-8420-4
Chapitre d'ouvrage
halshs-01938345
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Strengthening the quality and safety of Substance of Human Origin: what impact on fundamental rights?European Association of Health Law 2024, EAHL, University of Warsaw, Sep 2024, Warsaw, Poland
Communication dans un congrès
halshs-04842670
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Biomedical innovations in EU non- binding lawWorkshop I-BioLex on “Definitions and regulatory concepts in biolaw”, Aurélie Mahalatchimy; Xavier Magnon; Marie Glinel, Apr 2024, Aix-en -Provence, France
Communication dans un congrès
halshs-04842620
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The rise of the secretome: A comparative analysis of the governance of secretome-based interventions between Canada and the European UnionEuropean Association of Health Law 2024, European Association of Health Law 2024, Sep 2024, Warsaw (POLAND), Poland
Communication dans un congrès
halshs-04842630
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Roundtable on “Accelerating Cell and Gene Therapy Innovation: Regulatory Pathways in Europe”Advanced Therapies Europe 2024, Advanced Therapies Europe 2024, Sep 2024, Estoril (Portugal), Portugal
Communication dans un congrès
halshs-04842561
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De la sécurité à l'accès aux médicaments biologiques: les nouveaux enjeux prioritaires du biodroit de l'Union européenneQuel modèle pour le biodroit de l’Union européenne ?, Maria Fartunova- Michel, Mar 2024, Nancy, France
Communication dans un congrès
halshs-04842550
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Biomedical innovations in EU binding lawWorkshop I-BioLex on “Definitions and regulatory concepts in biolaw”, Aurélie Mahalatchimy; Xavier Magnon; Marie Glinel, Apr 2024, Aix-en -Provence, France
Communication dans un congrès
halshs-04842611
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Update on contributions on EU law on medicinesEU Health Law Seminar “Evolving EU health law following the Covid-19 pandemic”, Maynooth University, Jun 2023, Maynooth, Ireland
Communication dans un congrès
halshs-04290273
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Les spécificités règlementaires des essais cliniques pour les médicaments innovantsSéminaire « Essais cliniques », Groupe de travail interdisciplinaire Maladies rares ; Mutation ; Méditerranée (GT3M) des instituts d’établissement d’Aix-Marseille université, SoMuM (Sociétés en Mutation en Méditerranée) et MarMaRa (Marseille Maladies Rares), Apr 2023, Marseille, France
Communication dans un congrès
halshs-04290085
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Challenges arising from the pharmaceutical strategy and beyondPanel discussion on EU pharmaceutical activity, EUHealthGov - The EU Health Governance Research Network, Jan 2023, Online, United Kingdom
Communication dans un congrès
halshs-04166046
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Roundtable on “Regulatory Revolution: Global Harmonization for Safe Personalized Medicines”International Society for Cell & Gene Therapy 2023 Annual Meeting, International Society for Cell & Gene Therapy, May 2023, Paris Palais des congrès, France
Communication dans un congrès
halshs-04290260
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Challenges for the implementation of the current EU legal frameworks to organoidsBiotechnologies: towards collective wisdom: New forms of life: how should organoids be regulated?, TESaCo Colloquium, cycles d’étude de l’Académie des sciences morales et politiques, May 2023, En ligne, France
Communication dans un congrès
halshs-04290123
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Panel discussion on EU pharmaceutical activity: challenges arising from the pharmaceutical strategy and beyondSérie de séminaire du EU Health Governance Research Network, Jan 2023, En ligne, France
Communication dans un congrès
hal-04579445
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Roundtable on “COVID-19 Hangover: How do we Regain the Trust in Research?”International Society for Cell & Gene Therapy 2023 Annual Meeting, International Society for Cell & Gene Therapy, May 2023, Paris Palais des congrès, France
Communication dans un congrès
halshs-04290264
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Quel futur pour le cadre juridique des tissus et des organes destinés à la transplantation ? Le cas des organoïdesJournée d'étude du projet ITEGOREC, ITEGOREC, Jun 2023, Compiègne, France
Communication dans un congrès
halshs-04290134
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Presentation of the Joint Statement on “Health as a fundamental value. Towards an equitable and inclusive pharmaceutical strategy for the EU”EU Health Policy Platform Annual Meeting, May 2022, Brussels, Belgium
Communication dans un congrès
halshs-03780299
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Les organoïdes en action : Les aspects éthiques dans ORGANACT, projet de recherche interdisciplinaire en sciences sociales sur les organoïdesLes rencontres du GDR organoïdes, Dec 2022, Paris, France
Communication dans un congrès
halshs-03905828
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The EuroGCT project and the potential involvement of EAHL membersMeeting of the EAHL Interest Group on Supranational Biolaw, Annual Conference of the European Association of Health Law, 20-22 April 2022, Apr 2022, Ghent, Belgium
Communication dans un congrès
halshs-03779362
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The pandemic Treaty from an EU law perspectiveRoundtable on “Access, equity and the relevance of the Pandemic Treaty: lessons from the COVID-19 response” 15th European Public Health Conference 2022, Elena Petelos, organisator of the roundtable, Nov 2022, Berlin, Germany
Communication dans un congrès
halshs-03901516
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Natalité et TranshumanismeLa natalité comme enjeu stratégique de politique de santé publique, 10ème Colloque international France-Chine, 8ème rencontre franco-chinoise de la santé, Bénédicte BEVIERE-BOYER; Xin CHEN, Dec 2022, Online, France
Communication dans un congrès
halshs-03901474
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Le point de vue de juristes sur « Transhumansime :de nouveaux droits »Conférence « Transhumansime :de nouveaux droits » Partie 1, Mar 2021, Aix-en-Provence, France
Communication dans un congrès
halshs-03182638
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Les droits fondamentaux comme frontières de la médecine améliorative de l'humainColloque webinaire, "Le transhumanisme à l'ère de la médecine améliorative", May 2021, Virtual, France
Communication dans un congrès
halshs-03406626
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Health as a fundamental value. Towards an equitable and inclusive pharmaceutical strategy for the EUEU Health Policy Platform Kick-off meeting, 2021 Thematic Networks, Sep 2021, Aix-en-Provence, France
Communication dans un congrès
halshs-03406461
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Présentation du projet de recherche « Transhumansime: de nouveaux droits » Partie 2Conférence « Transhumansime: de nouveaux droits » Partie 2, May 2021, Aix-en-Provence, France
Communication dans un congrès
halshs-03406463
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Activities of the EAHL IG on Supranational Biolaw in 2021-2022: Public consultation & Thematic NetworkMeeting of the EAHL Interest Group on Supranational Biolaw, 20 April 2022, Annual Conference of the European Association of Health Law, Ghent, Belgium, 20-22 April 2022., Apr 2021, Ghent, Belgium
Communication dans un congrès
halshs-03779357
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Les cellules souches et la recherche dans la révision de la loi relative à la bioéthiqueColloque « Regards croisés sur la loi de bioéthique », Oct 2021, Toulouse, France
Communication dans un congrès
halshs-03406629
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Bioconstitutionalism in the European Union regulation of gene-editing technologiesThe Global Summit organized by The International Forum on the Future of Constitutionalism, Jan 2021, Virtual, France
Communication dans un congrès
halshs-03182619
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Le génome humain édité : risques et gouvernancee-colloque « Analyse des risques en santé : entre droit(s), sciences, éthique et attentes sociétales approches européenne et nationale », Journées Louis Dubouis, Mar 2021, Toulouse, France
Communication dans un congrès
halshs-03182591
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Framing and Legitimating EU Legal Regulation of Human Gene-Editing Technologies: Key Facets and Functions of an ImaginaryVirtual Symposium of the Journal of law and the Biosciences on “Law, Biomedical Technoscience and Imaginaries”, Feb 2021, Virtual, France
Communication dans un congrès
halshs-03182625
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Présentation du projet de recherche "Transhumanisme: de nouveaux droits?Conférence « Transhumansime :de nouveaux droits » Partie 1, Mar 2021, Aix-en-Provence, France
Communication dans un congrès
halshs-03182634
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Health as a fundamental value. Towards an inclusive and equitable pharmaceutical strategy for the EUHealth in Europe, Oct 2021, Virtual, France
Communication dans un congrès
halshs-03406630
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La révision de la loi française relative à la bioéthique et les médicaments de thérapie innovanteRencontre « Médicaments de thérapie innovante » Eurobiomed, Sep 2021, Marseille, France
Communication dans un congrès
halshs-03406628
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Proposal on “Health as a fundamental value. Towards an equitable and inclusive pharmaceutical strategy for the EU”EU Health Policy Platform Pitch webinar, 2021 Thematic Network semi-finalists, Jul 2021, Aix-en Provence, France
Communication dans un congrès
halshs-03406460
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Medicines as private goods for common use? An argumentation from medicines based on human biological elementsWorkshop on “The market for medicines in the face of unsatisfied needs: emergency adaptations or a reform on a permanent legal basis?”, Nov 2020, Dijon, France
Communication dans un congrès
halshs-03182597
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Law and ethics beyond gene editing46th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), Aug 2020, Virtual, France
Communication dans un congrès
halshs-03406624
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L’édition du génome humain face au droitConférence de l’Université Pour Tous, Oct 2020, Cahors, France
Communication dans un congrès
halshs-03406625
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Médicaments de thérapie innovante et gestion des risques: quelle place pour le principe de précaution?Journées Louis Dubouis, Les nouveaux enjeux de la politique pharmaceutique européenne: pour des produits de santé sûrs, innovants et accessibles, N. de Grove-Valdeyron,, May 2018, Toulouse, France
Communication dans un congrès
halshs-01938434
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Medical devices vs medicinal products: what is the impact of the recent European regulatory changes?Annual Meeting on Law & Society, Jun 2018, Toronto, Canada
Communication dans un congrès
halshs-01938450
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Introduction to the session on the values of biomedical innovationEuroScience Open Forum, Jul 2018, Toulouse, France
Communication dans un congrès
halshs-01938459
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The values of biomedical innovation: the legal viewEuroScience Open Forum, Jul 2018, Toulouse, France
Communication dans un congrès
halshs-01938462
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How can we facilitate the delivery of advanced therapies to patients?44th ANNUAL MEETING of the European Society for Blood and Marrow Transplantation (EBMT2108), Mar 2018, Lisbonne, Portugal
Communication dans un congrès
halshs-01769053
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Legal and ethical controversies around medical uses of stem cells: Is Medical Ethics Really in the Best interest of the Patient?Extra Session on Stem Cells Ethics, Jun 2010, Uppsala, Sweden
Communication dans un congrès
hal-03569764
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Transformer des cellules souches embryonnaires : quels enjeux éthiques et juridiques18th world Congress on Medical Law, Aug 2010, Zagreb, Croatia
Communication dans un congrès
hal-03569740
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Real access to ATMPs: the cost issueEuropean Society of Gene & Cell Therapy 2024, Oct 2024, Rome, Italy
Poster de conférence
halshs-04842702
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Organoids in action: an interdisciplinary approach in social sciences (Organact)French Society for Stem Cell Research, 6th Annual Meeting, Jan 2024, Paris, France
Poster de conférence
halshs-04842583
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Organoids in action: an interdisciplinary approach in social sciences (Organact)Symposium on cortical and spinal organoids, Jan 2024, Paris, France
Poster de conférence
halshs-04842598
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Expediting marketing authorization pathways for patients’ access to advanced therapiesEuropean Association of Health Law 2024, Sep 2024, Warsaw, Poland
Poster de conférence
halshs-04842656
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An exploratory analysis on the involvement of European organisations in the field of biomedical innovationEuropean Society for Gene & Cell Therapy Congress 2023, Oct 2023, Bruxelles (BEL), Belgium
Poster de conférence
halshs-04290569
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Mapping the ATMPs Guidance LandscapeEuropean Society for Gene & Cell Therapy Congress 2023, Oct 2023, Bruxelles (BEL), Belgium
Poster de conférence
halshs-04290574
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Finding out the regulatory requirements for the development of Gene and Cell therapy products with the EuroGCT research pathwaysEuropean Society for Blood and Marrow Transplant 49th annual meeting, Apr 2023, Paris, France
Poster de conférence
halshs-04290303
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Comparing actors participating in the adoption process of SoHo and ATMP regulations at the European levelEuropean Society for Gene & Cell Therapy Congress 2023, Oct 2023, Bruxelles (BEL), Belgium
Poster de conférence
halshs-04290588
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Which actors to influence the adoption of EU guidelines for Advanced Therapy Medicinal Products?International Society for Cell & Gene Therapy 2023 Annual Meeting, May 2023, Paris Palais des congrès, France. Elsevier, Abstract published in Cytotherapy, 25 (6 Supplement), pp.S161, 2023
Poster de conférence
halshs-04290558
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The European regulation on Health Technology Assessment Balancing European and National LevelsInternational Society for Cell & Gene Therapy 2023 Annual Meeting, May 2023, Paris Palais des congrès, France. Elsevier, Abstract published in Cytotherapy, 25 (6 Supplement), pp.S161, 2023
Poster de conférence
halshs-04290552
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The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European UnionInternational Society for Cell & Gene Therapy 2023 Annual Meeting, May 2023, Paris Palais des congrès, France. Abstract published in Cytotherapy, 25 (6 Supplement), pp.S160-S161, 2023
Poster de conférence
halshs-04290539
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The challenges of Advanced Therapy Medicinal Products manufacturing in the European Union: Strengths and limits of current regulatory toolsEuropean Society for Gene & Cell Therapy Congress 2023, Oct 2023, Bruxelles (BEL), Belgium
Poster de conférence
halshs-04290578
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Mapping regulators’ early interactions procedures to support innovationEuropean Society for Gene & Cell Therapy Congress 2023, Oct 2023, Bruxelles (BEL), Belgium
Poster de conférence
halshs-04290584
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Innovative therapy in European Parliament's positions: a numerical science-based vocabulary analysisEuropean Society for Gene & Cell Therapy Congress 2023, Oct 2023, Bruxelles (BEL), Belgium
Poster de conférence
halshs-04290599
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Bringing gene and cell therapies from lab to patients: the EuroGCT research pathwaysEuropean Society for Gene & Cell Therapy Congress 2022, Oct 2022, Edinburgh, United Kingdom
Poster de conférence
halshs-03901227
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Improving access to innovative medicines: proposals from national authorities to revise the European legislationEuropean Society for Gene & Cell Therapy Congress 2022, Oct 2022, Edinburgh, United Kingdom
Poster de conférence
halshs-03901248
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The new European regulation on Health Technology Assessment: what changes for Advanced Therapy Medicinal Products ?European Society for Gene & Cell Therapy Congress 2022, Oct 2022, Edinburgh, United Kingdom
Poster de conférence
halshs-03901269
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The current revision of the orphan medicines regulation in the EU: what is at stake for gene and cell therapy?European Society for Gene & Cell Therapy Congress 2022, Oct 2022, Edinburgh, United Kingdom.
Poster de conférence
halshs-03901429
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Specific guidelines requirements for clinical trials with Advanced Therapy Medicinal Products in the EUEuropean Society for Gene & Cell Therapy Congress 2022, Oct 2022, Edinburgh, United Kingdom. MARY ANN LIEBERT, 33 (23-24), pp.A197-A197, 2022
Poster de conférence
halshs-03901386
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Comparative quality aspects of gene therapy medicinal products and medicinal products containing genetically modified cellsAnnual Conference of the European Association of Health Law, Apr 2022, Ghent, Belgium
Poster de conférence
halshs-03779383
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What are the quality challenges regarding comparibility considerations of Advanced Therapy Medicinal Products?Annual Conference of the European Association of Health Law, Apr 2022, Ghent, Belgium
Poster de conférence
halshs-03780293
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What specificity for the clinical aspects of investigational advanced therapy medicinal products?Annual Conference of the European Association of Health Law, Apr 2022, Ghent, Belgium
Poster de conférence
halshs-03780286
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Production Aspects of Advanced Therapy Medicinal ProductsAnnual Conference of the European Association of Health Law, Apr 2022, Ghent, Belgium
Poster de conférence
halshs-03779408
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Quality control and batch release aspects of Advanced Therapy Medicinal ProductsAnnual Conference of the European Association of Health Law (8th EAHL-Conference), Apr 2022, Ghent, Belgium
Poster de conférence
halshs-03780272
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Production of ATMPs: What are the specificities for quality aspects ?European Society for Gene & Cell Therapy Congress 2022, Oct 2022, Edinburgh, United Kingdom. MARY ANN LIEBERT, INC140 HUGUENOT STREET, 3RD FL, NEW ROCHELLE, NY 10801, 33 (23-24), pp.A196-A197, 2022
Poster de conférence
halshs-03901462
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La recherche sur « Transhumanisme : de nouveaux droits ? »Conférence « Transhumansime :de nouveaux droits » Partie 1 et Partie 2, Mar 2021, Aix-en-Provence, France
Poster de conférence
halshs-03182651
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OBSERVATIONS SUR LA COMMUNICATION, LES RELATIONS INTERPERSONNELLES ET LES INTERACTIONS DANS LES CLASSES AUTOUR DE LA THEMATIQUE « TRANSHUMANISME ET DROIT »Conférence « Transhumansime :de nouveaux droits » Parties 1 et 2, Mar 2021, Aix-en-Provence, France
Poster de conférence
halshs-03182658
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Le sport augmenté, une révolution en marche à autoriser ?Transhumansime : de nouveaux droits, May 2021, Aix-en-Provence, France
Poster de conférence
halshs-03406451
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Des dispositifs médicaux au service du transhumanisme: jusqu’où doit-on aller ?Transhumansime : de nouveaux droits, May 2021, Aix-en-Provence, France
Poster de conférence
halshs-03406456
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Thérapie génique germinale et transhumanisme: entre amélioration de la qualité de vie et eugénismeConférence « Transhumansime :de nouveaux droits » Partie 2, May 2021, Aix-en-Provence, France
Poster de conférence
halshs-03405330
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Quels bébés pour demain?Transhumansime: de nouveaux droits, May 2021, Aix-en-Provence, France
Poster de conférence
halshs-03406459
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ÉVALUATION À MI-PARCOURS DU PROJET DE RECHERCHE RELATIF AU TRANSHUMANISMEConférence « Transhumansime :de nouveaux droits » Parties 1 et 2, Mar 2021, Aix-en-Provence, France
Poster de conférence
halshs-03182671
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The delivery of advanced therapies to patients: challenges and solutionsEuroScience Open Forum, Jul 2018, Toulouse, France
Poster de conférence
halshs-01938479
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Advanced Therapy Medicinal ProductsThe Oxford Encylopedia of EU Law [OEEUL], 2025, https://opil-ouplaw-com.lama.univ-amu.fr/display/10.1093/law-oeeul/law-oeeul-e230
Notice d’encyclopédie ou de dictionnaire
halshs-04989865
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MedicinesThe Oxford Encylopedia of EU Law [OEEUL], 2025, https://opil-ouplaw-com.lama.univ-amu.fr/display/10.1093/law-oeeul/law-oeeul-e231
Notice d’encyclopédie ou de dictionnaire
halshs-04989855
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Orphan medicinesOxford Encyclopedia of EU Law, 2023, https://opil.ouplaw.com/display/10.1093/law-oeeul/law-oeeul-e169
Notice d’encyclopédie ou de dictionnaire
halshs-04166004
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Marketing authorisation of generics, biosimilars, and hybrid medicinal productsThe Oxford Encylopedia of EU Law [OEEUL], 2022
Notice d’encyclopédie ou de dictionnaire
halshs-03901028
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Packaging and labelling of medicinesThe Oxford Encylopedia of EU Law [OEEUL], 2022
Notice d’encyclopédie ou de dictionnaire
halshs-03901039
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Manufacturing and batch testing of medicinesThe Oxford Encylopedia of EU Law, 2022
Notice d’encyclopédie ou de dictionnaire
halshs-03901017
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Transparency of medicines pricingThe Oxford Encylopedia of EU Law [OEEUL], 2022
Notice d’encyclopédie ou de dictionnaire
halshs-03901058
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Principes fondamentaux de la protection des données2024
Traduction
halshs-04842521
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Utilisation abusive / détournée des données2024
Traduction
halshs-04842494
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Autorités de protection des données2024
Traduction
halshs-04842512
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Classification des données2024
Traduction
halshs-04842503
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