AM
Aurélie Mahalatchimy
104
Documents
Researcher identifiers
aurelie-mahalatchimy- IdRef : 172268745
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0000-0002-4365-2143
Presentation
**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.
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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⟩
Books
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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⟩
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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⟩
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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
Book sections
halshs-04472769v1
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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⟩
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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⟩
Book sections
halshs-02943145v1
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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⟩
Book sections
halshs-02943155v1
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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
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halshs-03044087v1
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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⟩
Book sections
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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
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halshs-01938345v1
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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
Book sections
halshs-01938427v1
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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
Conference papers
halshs-04290134v1
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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
Conference papers
halshs-04290085v1
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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
Conference papers
halshs-04290273v1
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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
Conference papers
halshs-04290260v1
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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
Conference papers
halshs-04166046v1
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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
Conference papers
hal-04579445v1
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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
Conference papers
halshs-04290264v1
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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
Conference papers
halshs-04290123v1
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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
Conference papers
halshs-03780299v1
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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
Conference papers
halshs-03901474v1
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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
Conference papers
halshs-03905828v1
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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
Conference papers
halshs-03901516v1
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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
Conference papers
halshs-03779362v1
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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
Conference papers
halshs-03779357v1
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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
Conference papers
halshs-03406626v1
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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
Conference papers
halshs-03182638v1
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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
Conference papers
halshs-03182625v1
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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
Conference papers
halshs-03406629v1
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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
Conference papers
halshs-03182591v1
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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
Conference papers
halshs-03182619v1
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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
Conference papers
halshs-03406463v1
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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
Conference papers
halshs-03406461v1
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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
Conference papers
halshs-03182634v1
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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
Conference papers
halshs-03406460v1
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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
Conference papers
halshs-03406630v1
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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
Conference papers
halshs-03406628v1
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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
Conference papers
halshs-03182597v1
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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
Conference papers
halshs-03406624v1
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L’édition du génome humain face au droitConférence de l’Université Pour Tous, Oct 2020, Cahors, France
Conference papers
halshs-03406625v1
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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
Conference papers
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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
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The values of biomedical innovation: the legal viewEuroScience Open Forum, Jul 2018, Toulouse, France
Conference papers
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Introduction to the session on the values of biomedical innovationEuroScience Open Forum, Jul 2018, Toulouse, France
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halshs-01938459v1
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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
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halshs-01938450v1
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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
Conference papers
hal-03569764v1
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Transformer des cellules souches embryonnaires : quels enjeux éthiques et juridiques18th world Congress on Medical Law, Aug 2010, Zagreb, Croatia
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hal-03569740v1
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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
Conference poster
halshs-04290539v1
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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
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halshs-04290578v1
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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
Conference poster
halshs-04290599v1
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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
Conference poster
halshs-04290303v1
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Mapping the ATMPs Guidance LandscapeEuropean Society for Gene & Cell Therapy Congress 2023, Oct 2023, Bruxelles (BEL), Belgium
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halshs-04290574v1
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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
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halshs-04290569v1
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Mapping regulators’ early interactions procedures to support innovationEuropean Society for Gene & Cell Therapy Congress 2023, Oct 2023, Bruxelles (BEL), Belgium
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halshs-04290584v1
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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
Conference poster
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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
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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
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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
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halshs-03780293v1
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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
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halshs-03901462v1
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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
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halshs-03901248v1
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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
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halshs-03901269v1
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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
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halshs-03901227v1
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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
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halshs-03779383v1
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The current revision of the orphan medicines regulation in the EU: what is at stake for gene and cell therapy?Conference poster halshs-03901429v1 |
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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
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halshs-03901386v1
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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
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halshs-03780286v1
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Production Aspects of Advanced Therapy Medicinal ProductsAnnual Conference of the European Association of Health Law, Apr 2022, Ghent, Belgium
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halshs-03779408v1
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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
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halshs-03780272v1
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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
Conference poster
halshs-03405330v2
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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
Conference poster
halshs-03406456v2
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Le sport augmenté, une révolution en marche à autoriser ?Transhumansime : de nouveaux droits, May 2021, Aix-en-Provence, France
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halshs-03406451v2
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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
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halshs-03182671v1
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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
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halshs-03182651v1
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Quels bébés pour demain?Transhumansime: de nouveaux droits, May 2021, Aix-en-Provence, France
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halshs-03406459v2
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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
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halshs-03182658v1
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The delivery of advanced therapies to patients: challenges and solutionsEuroScience Open Forum, Jul 2018, Toulouse, France
Conference poster
halshs-01938479v1
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Interview with Tamara K. Hervey – EU health law in the UK: From the past to the present, and towards the future2024, https://confluencedesdroits-larevue.com/?p=3591
Other publications
halshs-04669907v1
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Post/Trans-humanisme et droits de l’Homme - Dimension économiqueDocuments de réflexion: transhumansimes et droits de l’homme, 2019
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halshs-02158115v1
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A. MAHALATCHIMY, interviewée par Philippe Testard-Vaillant, Innovations biomédicales: le droit comme garde-fou2019
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halshs-02158112v1
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Genome editing and the European UnionGenome editing and the law around the world, 2019
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halshs-02158076v1
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Conflicting values of biomedical innovation?2018
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Regulation of stem cell research in the United Kingdom2017
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halshs-01769219v1
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Regulation of stem cell research in France2017
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halshs-01769093v1
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