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Outputs

Articles

  1. A. MAHALATCHIMY, Le développement de la solidarité et la circulation des ressources biologiques humaines dans la révision de la loi relative à la bioéthique, AJDA 2021, n°32, pp. 1856-1866.
  2. A. MAHALATCHIMY et E. RIAL-SEBBAG, Deciphering the fragmentation of the human genome editing regulatory landscape, Frontiers in Political Science, Politics of Technology, 3:793134. doi: 10.3389/fpos.2021.793134, accepted on 13 December 2021, Published on 27 January 2022.
  3. E. GENNET et A. MAHALATCHIMY, La plateforme des politiques de santé de l’Union européenne : un outil de participation civile à la construction du droit, Revue de l’Union européenne, Janvier 2023, n°664, pp. 52- 58.
  4. A. MAHALATCHIMY, Challenges for the implementation of the current EU legal frameworks to organoids, in A. LE GOFF, S. CIRANNA, S. DE CHADAREVIAN, S. DESMOULIN, « Biotechnologies: towards collective wisdom », Les Cahiers TESACO N°4, Juin 2024, pp.47-56.
  5. M. MORRISON, V. BRUNEL, & A. MAHALATCHIMY, Participation in SoHO and ATMP public consultations: a fragmented institutional landscape. Humanit Soc Sci Commun 12, 262 (2025), In Open access. https://doi.org/10.1057/s41599-025-04552-1
  6. A. MAHALATCHIMY, V. ROBY, J. VÉRAN, C. CHABANNON, F. SABATIER, Mapping the European landscape and specificity of ATMPs guidance, Cytotherapy, Epub 20 June 2025, Volume 27, Issue 10, p.1262-1269, October 2025,  In Open access. https://doi.org/10.1016/j.jcyt.2025.06.008 
  7. A. MAHALATCHIMY, X. MAGNON et M. GLINEL, Pourquoi un dossier sur les définitions et les concepts du biodroit ?, Confluence des droits [En ligne], mis en ligne le 7 juillet 2025; in A. MAHALATCHIMY, X. MAGNON et M. GLINEL (dir.), Dossier Définitions et concepts du biodroit, Confluence des droits [En ligne], 2025.
  8. A. BOTTACCI, The Multifaceted Definition of Organoids in Law, Confluence des droits [En ligne], mis en ligne le 7 juillet 2025.
  9. E. BROSSET, Observations à propos de la définition des organismes génétiquement modifiés en droit de l’Union européenne, Confluence des droits [En ligne], mis en ligne le 7 juillet 2025.
  10. E. GENNET and A. MAHALATCHIMY, Is there a legal concept of biomedical innovations in EU binding law?, Confluence des droits [En ligne], mis en ligne le 7 juillet 2025.
  11. E. GENNET and A. MAHALATCHIMY, How does EU non‑binding law contribute to the scientific concept of biomedical innovations?, Confluence des droits [En ligne], mis en ligne le 7 juillet 2025.
  12. M. GLINEL, L’influence des traditions juridiques sur les définitions européennes du biodroit, Confluence des droits [En ligne], mis en ligne le 7 juillet 2025.
  13. X. MAGNON, De l’usage des concepts dans le droit biomédical. La part de la science du droit, Confluence des droits [En ligne], mis en ligne le 7 juillet 2025.
  14. M. BERNARDOT, From the Golem to The Man-Thing. Exploring the imaginary of biotechnology through metaphors, METABASIS [Online], In press
  15. Hervey, T. K., Bartlett, O., Cayón-De las Cuevas, J., Delhomme, V. N., den Exter, A., de Ruijter, A., Ðuković, M., Flear, M. L., Frischhut, M., Gennet, É., Goffin, T., Guy, M., Lau, P. L., Mahalatchimy, A., Michalak, M., Raposo, V. L., Slokenberga, S., & Schrauwen, A. (2026). Conceptualising European Union Health Law. European Journal of Health Law (14 April 2026, published online ahead of print 2026). https://doi.org/10.1163/15718093-bja10167
  16. A. MAHALATCHIMY, M. GLINEL, T.K. HERVEY, Understanding European Union SoHO caselaw through defragmentation and fragmentation, (2026). Conceptualising European Union Health Law. European Journal of Health Law(5 May 2026, published online ahead of print 2026) : https://doi-org/10.1163/15718093-bja10166

Special issue

  1. A. MAHALATCHIMY, X. MAGNON et M. GLINEL (dir.), Dossier Définitions et concepts du biodroit, Confluence des droits [En ligne], mis en ligne le 7 juillet 2025.

Chapters

  1. MAHALATCHIMY, Regulation of Genome Editing in Human iPS Cells: France, in H.-G. DEDERER, G. FRENKEN (eds.), Genome Editing in Human iPS Cells: A Comparative Legal Analysis of National Regulatory Frameworks for iPSC-based Cell/Gene Therapies, Springer, 2022, ISBN 978-3-030-93022-6, pp. 83-106.
  2. MAHALATCHIMY, G. NICOLAS, Les droits fondamentaux comme frontières de la médecine améliorative de l’humain : l’application du principe d’égalité, in A. Cayol, B. Bévière-Boyer, E. Gaillard et W.Wang, (dir.), Le transhumanisme à l’ère de la médecine améliorative, éditions Mare et Martin, Collection de la Chaire d’excellence CNRS : Normandie pour la Paix, 4 Janvier 2024, pp. 309-329.
  3. A. MAHALATCHIMY, G. NICOLAS, « Du transhumain au posthumain : quels droits fondamentaux ? », in A. MAHALATCHIMY, G. NICOLAS (Dir.), Transhumanisme : de nouveaux droits ?, DICE Éditions, 2024, pp.103-124, https://doi.org/10.4000/11zc5.
  4. A. MAHALATCHIMY, « Le biodroit comme modèle des nouveaux enjeux prioritaires du droit pharmaceutique de l’Union européenne », in M. FARTUNOVA-MICHEL, B. NABLI, Quel biodroit pour l’Union européenne ?, Bruylant, 2025, pp. 243- 274.
  5. C. CHABANNON, A. MAHALATCHIMY, « The Regulatory Framework for CAR-T Cells in Europe: Current Status and Foreseeable Changes », in Nicolaus Kröger, John Gribben, Christian Chabannon, Ibrahim Yakoub-Agha, Hermann Einsele, The EBMT/EHA CAR-T Handbook, Open Access, 2025/2026.
  6. A. MAHALATCHIMY, « Le vivant humain individualisé et le droit de l’Union européenne », in M. BOUTEILLE BRIGANT, Droit du vivant, Colloques & Essais, Institut Louis Joinet (Institut Francophone pour la Justice et la Démocratie), 2026, pp.99-117.

Encyclopaedia Entries

  1. F. TABOULET, A. MAHALATCHIMY, “Manufacturing and batch testing of medicines”, in S. GARBEN, L. GORMLEY, The Oxford Encylopedia of EU Law [OEEUL], January 2022: https://opil-ouplaw-com.lama.univ-amu.fr/display/10.1093/law-oeeul/law-oeeul-e167
  2. F. TABOULET, A. MAHALATCHIMY, “Packaging and labelling of medicines”, in S. GARBEN, L. GORMLEY, The Oxford Encylopedia of EU Law [OEEUL], 2022: https://opil-ouplaw-com.lama.univ-amu.fr/display/10.1093/law-oeeul/law-oeeul-e170
  3. F. TABOULET, A. MAHALATCHIMY, “Transparency of medicines pricing”, in S. GARBEN, L. GORMLEY, The Oxford Encylopedia of EU Law [OEEUL], 2022: https://opil-ouplaw-com.lama.univ-amu.fr/display/10.1093/law-oeeul/law-oeeul-e161
  4. F. TABOULET, A. MAHALATCHIMY, “Marketing authorisation of generics, biosimilars, and hybrid medicinal products”, in S. GARBEN, L. GORMLEY, The Oxford Encylopedia of EU Law [OEEUL], 2022: https://opil-ouplaw-com.lama.univ-amu.fr/display/10.1093/law-oeeul/law-oeeul-e166
  5. F. TABOULET, A. MAHALATCHIMY, “Health technology assessment (HTA)”, in S. GARBEN, L. GORMLEY, OUP Online Encyclopedia of EU Law, [OEEUL], October 2021.
  6. E. GENNET, A. MAHHALATCHIMY, “Orphan Medicines”, in S. GARBEN, L. GORMLEY, The Oxford Encylopedia of EU Law [OEEUL], 2023.
  7. A. MAHALATCHIMY, T.K. HERVEY, “Medicines”, in S. GARBEN, L. GORMLEY, The Oxford Encyclopedia of EU Law [OEEUL], February 2025.
  8. I. FAUSCH, A. MAHALATCHIMY, “Advanced Therapy Medicinal products”, in S. GARBEN, L. GORMLEY, The Oxford Encyclopedia of EU Law [OEEUL], February 2025.
  9. B. JUILLARD-CONDAT, A. MAHALATCHIMY, “Pharmacovigilance“, in S. GARBEN, L. GORMLEY, OUP Online Encyclopedia of EU Law, [OEEUL], June 2026.

Replies to Public consultations

  1. A. MAHALATCHIMY, P. L. LAU, M. GUERRIAUD, P. LI, E. GENNET, E. RIAL-SEBBAG, C. CHABANNON on behalf of the EAHL Interest Group on Supranational Biolaw and the I-BioLex research project, réponse à la Consultation publique de la Commission européenne sur « the revision of the general pharmaceutical legislation”, 20 décembre 2021.
  2. E. GENNET, N. DUBRUEL, M. FRISCHHUT, A. MAHALATCHIMY on behalf of the EAHL Interest Group on Supranational Biolaw and the I-BioLex research project, réponse à la Consultation publique de la Commission européenne sur « un nouvel agenda européen de l’innovation », 10 mai 2022.
  3. A. MAHALATCHIMY and E. GENNET on behalf of the EAHL Interest Group on Supranational Biolaw and the I-BioLex research project, réponse à la Consultation publique de la Commission européenne sur “the final evaluation of the third health programme 2014-2020”, 3 juin 2022: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12604-final-evaluation-of-the-3rd-health-programme-2014-2020/public-consultation_fr
  4. A. SCHEER, V. ROBY, A. MAHALATCHIMY, on behalf of the I-BioLex research project, Réponse à la consultation publique de l’Agence Européenne des Médicaments sur “Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation”, 29 September 2023: https://www.ema.europa.eu/en/establishing-efficacy-based-single-arm-trials-submitted-pivotal-evidence-marketing-authorisation#ema-inpage-item-10171
  5. A. MAHALATCHIMY, J. VERAN, T.K. HERVEY, on behalf of the I-BioLex research project, Réponse à la consultation publique de la Commission européenne sur “The European Biotech act”, 10 November 2025: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14627-Biotech-Act/public-consultation_en

Oral Communications

  1. A. MAHALATCHIMY, G. NICOLAS, Les droits fondamentaux comme frontières de la médecine améliorative de l’humain, Colloque webinaire, “Le transhumanisme à l’ère de la médecine améliorative”, 11 mai 2021, en ligne.
  2. E. GENNET, A. MAHALATCHIMY, 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, Wednesday 7 July 2021.
  3. A. MAHALATCHIMY, La révision de la loi française relative à la bioéthique et les médicaments de thérapie innovante, Rencontre « Médicaments de thérapie innovante » Eurobiomed, 14 septembre 2021, Marseille.
  4. E. GENNET, A. MAHALATCHIMY, Thematic network “Health as a fundamental value. Towards an equitable and inclusive pharmaceutical strategy for the EU”, EU Health Policy Platform Kick-off meeting, 2021 Thematic Networks, Friday 24 September 2021.
  5. A. MAHALATCHIMY, Cellules souches et recherche, Colloque « Regards croisés sur la loi de bioéthique », Institut Maurice Hauriou – Chaire UNESCO – Espace de Réflexion Éthique Occitanie sous la direction scientifique de X. Bioy, E. Rial-Sebbag et de l’Espace de Réflexion Éthique Occitanie, 14 et 15 Octobre 2021, Toulouse.
  6. E. GENNET et A. MAHALATCHIMY, Health as a fundamental value. Towards an inclusive and equitable pharmaceutical strategy for the EU, Webinar “Health in Europe”, 20 October 2021.
  7. E. GENNET, « Questions éthiques et juridiques du développement de médicaments en Europe », Enseignant invité, Aix-Marseille Université, Institut Portalis, Aix-en-Provence, France, 1 février 2022.
  8. E. GENNET, « L’évolution du droit européen en matière d’essais cliniques de médicaments », Enseignant invité, Journée de formation du Comité de Protection des Personnes Impliquées dans la Recherche Biomédicale Sud Méditerranée (CPPSM2), Le Tholonet, France, 29 avril 2022.
  9. E. GENNET, A. MAHALATCHIMY, 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, European Commissions, Brussels, 5 May 2022.
  10. A. MAHALATCHIMY, The pandemic Treaty from an EU law perspective, roundtable on “Access, equity and the relevance of the Pandemic Treaty: lessons from the COVID-19 response” organized by Elena PETELOS, 15th European Public Health Conference 2022, Berlin, Germany, 9-12 November 2022.
  11. A. MAHALATCHIMY et E. GENNET, Towards an inclusive and equitable pharmaceutical strategy for the EU, EUHealthGov network seminar series, Panel discussion / webinar on “EU Pharmaceutical Activity: Challenges Arising From The Pharmaceutical Strategy And Beyond”, 25 January 2023, en ligne.
  12. A. MAHALATCHIMY, La loi française relative à la bioéthique : évolutions et démocratisation, Conférence de l’Université Pour Tous-Cahors, 16 Février 2023, (Invitée).
  13. A. MAHALATCHIMY, Les spécificités règlementaires des essais cliniques pour les médicaments innovants, GT3M- Séminaire « Essais cliniques »- 13 avril 2023- Marseille, France.
  14. T HERVEY, Trust / Solidarity in EU health law’ for EU Health Governance: an opportunity for trust and solidarity? Amsterdam Law Centre for Health and Life, Amsterdam Centre for European Law and Governance, Amsterdam Centre for European Studies, University of Amsterdam, 13-14 April 2023
  15. A. MAHALATCHIMY, Challenges for the implementation of the current EU legal frameworks to organoids, TESaCo Colloquium on « Biotechnologies: towards collective wisdom », « New forms of life: how should organoids be regulated? », 22nd May 2023, online.
  16. A. MAHALATCHIMY, Roundtable on “Regulatory Revolution: Global Harmonization for Safe Personalized Medicines”, International Society for Cell & Gene Therapy 2023 Paris Annual Meeting, Paris, France, 31 May- 3 June 3 2023.
  17. A. MAHALATCHIMY, Roundtable on “COVID-19 Hangover: How do we Regain the Trust in Research?” International Society for Cell & Gene Therapy 2023 Paris Annual Meeting, Paris, France, 31 May- 3 June 3 2023.
  18. A. MAHALATCHIMY, Update on contributions on EU law on medicines, EU Health Law Seminar “Evolving EU health law following the Covid-19 pandemic”, Maynooth, Ireland, 23 June 2023.
  19. T HERVEY, ‘The European Union’s response to COVID-19’, for Nordic Biomedical Law Conference, Faculty of Law, University of Bergen, Norway, 31 August-1 September 2023
  20. A. MAHALATCHIMY, La recherche sur l’embryon et les cellules souches embryonnaires, Conférence de l’Université Pour Tous-Cahors, 8 Février 2024, (Invitée).
  21. A. MAHALATCHIMY, De la sécurité à l’accès aux médicaments biologiques: les nouveaux enjeux prioritaires du biodroit de l’Union européenne, Chaire Jean Monnet EUBioethics « Quel modèle pour le biodroit de l’Union européenne ? », Faculté de droit de Nancy, 14-15 mars 2024, Nancy, France (Invitée).
  22. E. BROSSET, La définition des Organismes génétiquement modifiés, I-BioLex Workshop « Definitions and regulatory concepts in Biolaw », Faculté de droit d’Aix, 9 avril 2024, Aix-en-Provence, France.
  23. E. GENNET, A. MAHALATCHIMY, The concept of biomedical innovations in EU binding law, I-BioLex Workshop « Definitions and regulatory concepts in Biolaw », Faculté de droit d’Aix, 9 avril 2024, Aix-en-Provence, France.
  24. A. MAHALATCHIMY, E. GENNET, How does EU non-binding law contribute to the scientific concept of BI?, I-BioLex Workshop « Definitions and regulatory concepts in Biolaw », Faculté de droit d’Aix, 9 avril 2024, Aix-en-Provence, France.
  25. E. RIAL-SEBBAG, The contribution of bioethics to the concept of health genetics, I-BioLex Workshop « Definitions and regulatory concepts in Biolaw », Faculté de droit d’Aix, 9 avril 2024, Aix-en-Provence, France.
  26. M. GLINEL, L’influence de la Common Law et du Droit Romain dans les définitions du biodroit, I-BioLex Workshop « Definitions and regulatory concepts in Biolaw », Faculté de droit d’Aix, 9 avril 2024, Aix-en-Provence, France.
  27. X. MAGNON, Conclusions, I-BioLex Workshop « Definitions and regulatory concepts in Biolaw », Faculté de droit d’Aix, 9 avril 2024, Aix-en-Provence, France.
  28. C. CHABANNON, CAR-T Cells et autres immunothérapies cellulaires, Colloque Grand Public du Comité de Paris de la Ligue contre le Cancer, 25 Avril 2024, Maison de l’Océan, Paris, France.
  29. C. CHABANNON, Le défi des médicaments de thérapie innovante pour l’organisation des CLCC, Santexpo 2024, 22 mai 2024, Paris, France.
  30. T HERVEY, ‘Continuities and discontinuities in medicines regulation in Northern Ireland’, for The Contours of Pharmaceutical Regulation in the EU, City, University of London, 11 June 2024.
  31. T HERVEY, ‘Strengthening legal preparedness in the European Union after the pandemic’ for Health Emergencies and Legal Preparedness in the EU: Taking stock of the post-pandemic reforms, University of Bologna, Italy 24 June 2024.
  32. A. MAHALATCHIMY, Roundtable on “Accelerating Cell and Gene Therapy Innovation: Regulatory Pathways in Europe”, Advanced Therapies Europe 2024, Estoril, Portugal, 10-12 September 2024.
  33. T HERVEY, ‘Reshoring of healthcare system capacities: a European human rights issue?’ for European Health Law Association Annual Conference, University of Warsaw, Poland, 18-20 September 2024.
  34. M. A. LITHOPOULOS, A. MAHALATCHIMY, A. ZARZECZNY, The rise of the secretome: A comparative analysis of the governance of secretome-based interventions between Canada and the European Union, EAHL 2024, 18-20 September 2024, Warsaw, Poland.
  35. M. GLINEL, A. MAHALATCHIMY, Strengthening the quality and safety of Substance of Human Origin: what impact on fundamental rights?, EAHL 2024, 18-20 September 2024, Warsaw, Poland.
  36. C. CHABANNON, Impact of regulatory changes on access to HSCT and IECs Regulatory aspects in HSCT and IEC, EBMT 2025, 51st Annual Meeting, 30 mars-2 avril 2025, Florence, Italy.
  37. T HERVEY, ‘EU Pandemic Preparedness: legal and policy dimensions’ for EUSA Conference: An Open EU: European Integration and Global Challenges? Pittsburgh, PA 8-10 May 2025.
  38. T HERVEY, ‘Gender equality in access to healthcare in European Union law’, with R Horton, for University of Utrecht, 27 May 2025.
  39. A. MAHALATCHIMY, Présentation de l’article “Mapping the European landscape and specificity of ATMPs guidance », Comité d’interface dédié aux médicaments de thérapie innovante, Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), 3 octobre 2025, Paris, France (en ligne) (Invitée).
  40. A. MAHALATCHIMY, Some thoughts on strategies for drafting clear, adaptable guidance for genome editing based medicines, Workshop on “Regulatory Frameworks and Clinical Applications in Gene Editing: Formulating Guidelines and Industrial Agreements”, organised by the European COST action “Genome Editing to Treat Human Diseases” (COST Action GenE-HumDi), 7 October 2025, Sevilla, Spain (Invitée).
  41. A. MAHALATCHIMY, Introduction of the Workshop “Fragmentation and defragmentation of the law on biomedical innovations”, University of Amsterdam, 30-31 October 2025, Amsterdam, The Netherlands.
  42. T HERVEY, M. GLINEL, A. MAHALATCHIMY, ‘Substances of human origin in CJEU case-law: fragmentation and defragmentation’, Workshop: Fragmentation and defragmentation of the law on biomedical innovations, University of Amsterdam, 30-31 October 2025.
  43. V. BRUNEL, I-BioLex Data Sharing & Data Paper, Workshop: Fragmentation and defragmentation of the law on biomedical innovations, University of Amsterdam, 30-31 October 2025.
  44. A. MAHALATCHIMY, Biological medicines as a model for general European legislation on medicinal products, Workshop: Fragmentation and defragmentation of the law on biomedical innovations, University of Amsterdam, 30-31 October 2025.
  45. F. SABATIER, V. ROBY, A. MAHALATCHIMY, Fragmentation and defragmentation of the European law on biomedical innovation in EU guidance, Workshop: Fragmentation and defragmentation of the law on biomedical innovations, University of Amsterdam, 30-31 October 2025.
  46. M. MORRISON, Fragmentation and defragmentation of the European law on biomedical innovation among institutions, Workshop: Fragmentation and defragmentation of the law on biomedical innovations, University of Amsterdam, 30-31 October 2025.
  47. L. GAY, Fundamental rights in the EU law on medical Innovations: what place? What conception?, Workshop: Fragmentation and defragmentation of the law on biomedical innovations, University of Amsterdam, 30-31 October 2025.
  48. E. GENNET, A Council of Europe perspective on biomedical innovations, Workshop: Fragmentation and defragmentation of the law on biomedical innovations, University of Amsterdam, 30-31 October 2025.
  49. M. FLEAR, M. GLINEL, A. MAHALATCHIMY, Fragmentation and Defragmentation in EU Law on Innovative Biomedicine: Revealing Dialectic Mechanisms of Legal Integration, Workshop: Fragmentation and defragmentation of the law on biomedical innovations, University of Amsterdam, 30-31 October 2025.
  50. X. MAGNON, The special issue on definitions and concepts in biolaw : overall results for the I-BioLex project, Workshop: Fragmentation and defragmentation of the law on biomedical innovations, University of Amsterdam, 30-31 October 2025.
  51. A. MAHALATCHIMY, Des frontières en mouvement: la fragmentation et la défragmentation du droit européen des innovations biomédicales, Colloque co-organisé par le CERIC et le CDSA “Aux frontières du droit de la santé”, Association Française de Droit de la Santé, 20-21 novembre 2025, Aix-en-Provence, France.
  52. T HERVEY, ‘Mutual recognition in EU health law’ with Vincent Delhomme and Tollef Otterdal Heggen, for United in Diversity:Interdisciplinary Perspectives on Mutual Recognition in European Law and Governance, Maastricht University, Netherlands, 29–30 January 2026.
  53. T HERVEY, ‘EU Health Competences within or beyond the EU Constitutional Framework’ for The Protection of Health in Europe: Actors and Legal Instruments (HEAL final conference), University of Bologna, Italy, 4 February 2026.
  54. A. MAHALATCHIMY, EU regulation on SoHO: potential consequences on the generation of real-world data, GoCART Coalition Session on “The Power of Real-World Education and Real-World Data”, 52nd EBMT Annual Meeting, 22-25 March 2026, Madrid, Spain. (Invitée)
  55. A. MAHALATCHIMY, Le vivant humain singularisé et le droit de l’Union européenne, Colloque “Le droit du vivant” organisé par M. Bouteille- Brigant, Themis-UM, 26 mars 2026, Le Mans, France. (Invitée)
  56. A. MAHALATCHIMY, What are the expected legislative changes within the EU regarding gene-editing technologies?, Workshop on “Addressing Regulatory, Technological-transfer and Industry Aspects in GenE-HumDi”, organised by the European COST action “Genome Editing to Treat Human Diseases” (COST Action GenE-HumDi), 21 April 2026, Paphos, Cyprus. (Invitée)
  57. A. MAHALATCHIMY, Présentation générale de la règlementation SoHO et de la proposition du Biotech Act, 5ème Rencontre des Intégrateurs en Biothérapies et en Bioproduction, 9-10 juin 2026, Besançon, France. (Invitée)
  58. A. MAHALATCHIMY, Biotechnology as a catalyst for a coherent and embedded EU regulation of bio-based products: the Commission’s proposal for an EU Biotech Act, EAHL 2026, 9-11 September 2026, Uppsala, Sweden.

Teaching

  1. A. MAHALATCHIMY, The fragmented regulatory landscape of human genome editing, CIVIS Blended Intensive Programme: science, ethics & governance of human genome editing, 5 July 2023, 9 July 2024, 3 July 2025, Online.
  2. A. MAHALATCHIMY, Human Genome Editing for Research & EU Law, CIVIS Blended Intensive Programme: science, ethics & governance of human genome editing, University of Tübingen, Germany, Saturday 29 July 2023.
  3. A. MAHALATCHIMY, Human Genome Editing for Therapy & EU Law, CIVIS Blended Intensive Programme: science, ethics & governance of human genome editing, University of Tübingen, Germany, Saturdays 29 July 2023, 20 July 2024,19 July 2025.
  4. E. GENNET, Rare diseases Foundation, European Reference Network Transplant Child, CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche/Clinical Validation from Biopharmaceutical Findings), “Innovative Therapies and Personalised Medicine for Rare Diseases” MOOC, European Joint Program Rare Diseases (EJPRD), July 2024, https://www.futurelearn.com/courses/innovative-therapies-and-personalised-medicine-for-rare-diseases/1. Contribution to 3 classes of the Week 5 Personalized therapies and real-world challenges program: 5.15 EU legal framework for orphan medicinal products; 5.17 Equity of access to treatment and 5.18 Access to innovative treatments for rare disease patients

Posters

  1. A. MAHALATCHIMY, E. GENNET, V. ANDRIEU, M. FERAUD, V. LACAILLE, J. VERAN, F. SABATIER, M. MORRISON, Comparative quality aspects of gene therapy medicinal products and medicinal products containing genetically modified cells, Annual Conference of the European Association of Health Law, Ghent, Belgium, 20-22 April 2022 (POSTER).
  2. J. VERAN, F. SABATIER, M. MORRISON, C. LE CORRE, C. S. PEIXOTO, E. GENNET, V. ANDRIEU, A. MAHALATCHIMY, Production Aspects of Advanced Therapy Medicinal Products, Annual Conference of the European Association of Health Law, Ghent, Belgium, 20-22 April 2022 (POSTER).
  3. J. VERAN, M. MORRISON, F. SABATIER, L. CHEY, F. MBODJ, E. GENNET, V. ANDRIEU, A. MAHALATCHIMY, Quality Control and Batch Release Aspects of Advanced Therapy Medicinal Products, Annual Conference of the European Association of Health Law, Ghent, Belgium, 20-22 April 2022 (POSTER).
  4. E. GENNET, F. SABATIER, J. VERAN, D. A. FATOU, N. MONGALGI, V. ANDRIEU, M. MORRISON, A. MAHALATCHIMY, What specificity for the clinical aspects of investigational advanced therapy medicinal products?, Annual Conference of the European Association of Health Law, Ghent, Belgium, 20-22 April 2022 (POSTER).
  5. V. ANDRIEU, E. GENNET, J. VERAN, M. MORRISON, F. SABATIER, A. MAHALATCHIMY, What are the quality challenges regarding comparability considerations of advanced therapy medicinal products? Annual Conference of the European Association of Health Law, Ghent, Belgium, 20-22 April 2022 (POSTER).
  6. A. MAHALATCHIMY, F. LANSON, B. BARTOS, F. TABOULET, Improving access to innovative medicines: proposals from national authorities to revise the European legislation, European Society for Gene & Cell Therapy Congress 2022, Edinburgh, the UK, 11-14 October 2022 (POSTER); Abstract published in Human Gene Therapy, Volume: 33 Issue 23-24: December 14, 2022, A1-A212. http://doi.org/10.1089/hum.2022.29225.abstracts.
  7. B. BARTOS, J. JUËT, F. TABOULET, A. MAHALATCHIMY, The new European regulation on Health Technology Assessment: what changes for Advanced Therapy Medicinal Products?, European Society for Gene & Cell Therapy Congress 2022, Edinburgh, the UK, 11-14 October 2022 (POSTER); Abstract published in Human Gene Therapy, Volume: 33 Issue 23-24: December 14, 2022, A1-A212.http://doi.org/10.1089/hum.2022.29225.abstracts.
  8. A. MAHALATCHIMY, E. GENNET, M. MORRISON, V. ANDRIEU, J. VERAN, F. SABATIER, Specific guidelines requirements for clinical trials with Advanced Therapy Medicinal Products in the European Union, European Society for Gene & Cell Therapy Congress 2022, Edinburgh, the UK, 11-14 October 2022 (POSTER); Abstract published in Human Gene Therapy, Volume: 33 Issue 23-24: December 14, 2022, A1-A212.http://doi.org/10.1089/hum.2022.29225.abstracts.
  9. A. MAHALATCHIMY, E. GENNET, The current revision of the orphan medicinal products regulation in the European Union: what is at stake for gene and cell therapy?, European Society for Gene & Cell Therapy Congress 2022, Edinburgh, the UK, 11-14 October 2022 (POSTER); Abstract published in Human Gene Therapy, Volume: 33 Issue 23-24: December 14, 2022, A1-A212.http://doi.org/10.1089/hum.2022.29225.abstracts.
  10. A. MAHALATCHIMY, E. GENNET, M. MORRISON, V. ANDRIEU, J. VERAN, F. SABATIER, Production of ATMPs: What are the specificities for quality aspects?, European Society for Gene & Cell Therapy Congress 2022, Edinburgh, the UK, 11-14 October 2022, (POSTER available at ⟨halshs-03901462⟩); Abstract published in Human Gene Therapy, Volume: 33 Issue 23-24: December 14, 2022, A1-A212.http://doi.org/10.1089/hum.2022.29225.abstracts.
  11. B. BARTOS, Contracts for better access to Advanced Therapy Medicinal Products, European Society for Gene & Cell Therapy Congress 2022, Edinburgh, the UK, 11-14 October 2022 (POSTER); Abstract published in Human Gene Therapy, Volume: 33 Issue 23-24: December 14, 2022, A1-A212. http://doi.org/10.1089/hum.2022.29225.abstracts
  12. A. MAHALATCHIMY, L.-S. GILBERT, A. DELAGE, O. NEGRE, The Marketing Authorisation of Advanced Therapy Medicinal Products in the European Union, International Society for Cell & Gene Therapy 2023 Paris Annual Meeting, Paris, France, 31 May- 3 June 3 2023 (POSTER); Abstract published in Cytotherapy Volume 25, Issue 6, Supplement, May 2023, Pages S160–S161.
  13. A. MAHALATCHIMY, J. JUËT, B. BARTOS, F. TABOULET, The European regulation on Health Technology Assessment: balancing European and national levels, International Society for Cell & Gene Therapy 2023 Paris Annual Meeting, Paris, France, 31 May- 3 June 3 2023 (POSTER) ; Abstract published in Cytotherapy Volume 25, Issue 6, Supplement, May 2023, Page S161.
  14. A. MAHALATCHIMY, V. BRUNEL, Which actors to influence the adoption of EU guidelines for Advanced Therapy Medicinal Products? International Society for Cell & Gene Therapy 2023 Paris Annual Meeting, Paris, France, 31 May- 3 June 3 2023 (POSTER); Abstract published in Cytotherapy Volume 25, Issue 6, Supplement, May 2023, Page S161.
  15. A. SCHEER, V. BRUNEL, S. GUION, I. CHIV, M. MORELL, M. DURAND, O. JOANINA, V. ANDRIEU, A. MAHALATCHIMY, An exploratory analysis on the involvement of European organisations in the field of biomedical innovation, European Society for Gene & Cell Therapy Congress 2023, Brussels, Belgium, 24-27 October 2023 (POSTER)
  16. V. ROBY, A. SCHEER, J. VERAN, F. SABATIER, A. MAHALATCHIMY, Mapping the ATMPs Guidance Landscape, European Society for Gene & Cell Therapy Congress 2023, Brussels, Belgium, 24-27 October 2023 (POSTER)
  17. L.-S. GILBERT, A. DELAGE, H.-Y. KUO, A. COUTURIER, A. MAHALATCHIMY, The challenges of Advanced Therapy Medicinal Products manufacturing in the European Union: Strengths and limits of current regulatory tools, European Society for Gene & Cell Therapy Congress 2023, Brussels, Belgium, 24-27 October 2023 (POSTER)
  18. A. DELAGE, L.-S. GILBERT, A. MAHALATCHIMY, Mapping regulators’ early interactions procedures to support innovation, European Society for Gene & Cell Therapy Congress 2023, Brussels, Belgium, 24-27 October 2023 (POSTER)
  19. V. BRUNEL, A. MAHALATCHIMY, Comparing actors participating in the adoption process of SoHo and ATMP regulations at the European level, European Society for Gene & Cell Therapy Congress 2023, Brussels, Belgium, 24-27 October 2023 (POSTER)
  20. T. ALLOUCHE, V. BRUNEL, F. BECHET, M. GLINEL, A. MAHALATCHIMY, Innovative therapy in European Parliament’s positions: a numerical science-based vocabulary analysis, European Society for Gene & Cell Therapy Congress 2023, Brussels, Belgium, 24-27 October 2023 (POSTER)
  21. V. ROBY, L.-S. GILBERT, V. BRUNEL, A. DELAGE, A. MAHALATCHIMY, Expediting marketing authorization pathways for patients’ access to advanced therapies, EAHL 2024, 18-20 September 2024, Warsaw, Poland (POSTER).
  22. A. MAHALATCHIMY, A. DELAGE, L.-S. GILBERT, H.-Y. KUO, V. ROBY, C. CHABANNON, Real access to ATMPs: the cost issue, ESGCT 2024, 22-25 October 2024, Roma, Italy (POSTER).
  23. VERAN, J. MAGALON, C. DUMOULIN, S. RABARIMERIARIJAONA, L. AGNELLI, M. VELIER ; F. SABATIER, A. MAHALATCHIMY, ATMPs: exceptional manufacturing returns to the patient’s bedside, ESGCT 2025, 7-10 October 2025, Sevilla, Spain (POSTER).
  24. A. BOTTACCI, G. NICOLAS, A. MAHALATCHIMY, Organoids and organs-on-chip in gene and cell therapy: which innovation strategies in France? ESGCT 2025, 7-10 October 2025, Sevilla, Spain (POSTER).
  25. V. ROBY, A. DELAGE, L.-S. GILBERT, A. BOTTACCI, A. MAHALATCHIMY, What regulatory pathways for health technologies using both medical devices and T&C in the European Union? ESGCT 2025, 7-10 October 2025, Sevilla, Spain (POSTER).
  26. A. DELAGE, L.-S. GILBERT, J. VERAN, V. ROBY, A. MAHALATCHIMY, A comparative study of national schemes and services for “early interaction” with Regulators, ESGCT 2025, 7-10 October 2025, Sevilla, Spain (POSTER)
  27. A. BOTTACCI, G. NICOLAS, A. MAHALATCHIMY, Obtaining cells for biomedical research and innovative therapies: which regulatory pathways in France?, FSSCR 2025, 17-19 November 2025, Lyon, France. (POSTER)
  28. A. MAHALATCHIMY, V. ROBY, C. CHABANNON, The new EU regulation on SoHO: strengthening the protection of donors, recipients and offspring, 52nd EBMT Annual Meeting, 22-25 March 2026, Madrid, Spain. (POSTER)
  29. C. CHABANNON, H. WAMUTITU, V. ROBY, A. MAHALATCHIMY, Tracking back innovation in different classes of newly developed therapeutic products through the linkage between Nobel and Galien prizes: the specificity of ATMPs, 52nd EBMT Annual Meeting, 22-25 March 2026, Madrid, Spain. (POSTER)
  30. A. MAHALATCHIMY, A. DELAGE, L.-S. GILBERT, V. ROBY, C. CHABANNON, Interactions with regulators for gene and cell therapy-based medicines to reach both the European and US markets, ISCT 2026, 6-9 May 2026, Dublin, Ireland. (POSTER)
  31. A. MAHALATCHIMY, V. ROBY, C. CHABANNON, The European Commission proposal for a new regulation on biotechnology: why does it matter for ATMP?, ISCT 2026, 6-9 May 2026, Dublin, Ireland. (POSTER)
  32. A. MAHALATCHIMY, V. ROBY, C. CHABANNON, The EU Reform of the pharmaceutical legislation: what changes can be expected for ATMP? , ISCT 2026, 6-9 May 2026, Dublin, Ireland. (POSTER)
  33. C. CHABANNON, H. WAMUTITU, V. ROBY, A. MAHALATCHIMY, Tracking back innovation in different classes of newly-developed medicinal products through the linkage between Nobel and Galien prizes supports a specific status for advanced therapies. an iBioLex project, ISCT 2026, 6-9 May 2026, Dublin, Ireland. (POSTER)
  34. A. MAHALATCHIMY, V. ROBY, C. CHABANNON, Quelles autorisations pour les activités portant sur les substances d’origine humaine sous le nouveau règlement européen 2024/1938 ?, IXème Congrès de la Société Française de Bio-Ingénierie Cellulaire et Tissulaire, 3-5 Juin 2026, Marseille, France (POSTER).
  35. A. BOTTACCI, G. NICOLAS, A. MAHALATCHIMY, C. CHABANNON, Quelles procédures réglementaires pour l’obtention et l’utilisation de cellules humaines destinées à la recherche biomédicale ? IXème Congrès de la Société Française de Bio-Ingénierie Cellulaire et Tissulaire, 3-5 Juin 2026, Marseille, France. (POSTER).
  36. A. BOTTACCI, G. NICOLAS, A. MAHALATCHIMY, How do in vitro gametogenesis and stem cell-based embryo models challenge the prohibition on creating embryos for research purposes?, ISSCR 2026, 8-11 July 2026, Montréal, Canada. (POSTER)
  37. A. BOTTACCI, G. NICOLAS , A. MAHALATCHIMY, Reassessing the legal status of the embryo in light of a combination of new technologies: a renewed debate, EAHL 2026, 9-11 September 2026, Uppsala, Sweden. (POSTER)

Deliverables/ Reports

A. MAHALATCHIMY, E. GENNET, M. MBENGUE, M. PERRON; C.-S. DONATI, I-BioLex, Deliverable D9-1: Data Management Plan, Juin 2021 (20 pages), DOI: 10.5281/zenodo.7085166.

Eloïse GENNET, Aurélie MAHALATCHIMY, Markus FRISCHHUT, Elena PETELOS, Pin Lean LAU, Tamara K HERVEY, Mark L FLEAR, Mary GUY, Inesa FAUSCH, Sabrina RÖTTGER-WIRTZ, Anne-Marie DUGUET, Isabelle MOINE-DUPUIS, Tomislav SOKOL, Mathieu GUERRIAUD, Joaquin CAYON-DE LAS CUEVAS, Marko OCOKOLJIC (SIOP Europe), Charlotte GODZIEWSKI, Olivier NEGRE (GCTI), Piotr KOLCZYNSKI (CPME), Francois HOUŸEZ (Eurordis), Hrishikesh KULKARNI, Marcin RODZINKA-VERHELLE (EPHA), Tadeusz HAWROT (PAREA), Joint statement on « Health as a fundamental value. Towards an inclusive and equitable pharmaceutical strategy for the European Union”, May 2022, 59 pages.

A. MAHALATCHIMY, Compte-rendu Intermédiaire du Projet I-BioLex, Juin 2022, 15 pages.

A. MAHALATCHIMY, E. GENNET, M. MBENGUE, M. PERRON; C.-S. DONATI, V. BRUNEL, L. MOSNIER, I-BioLex, Deliverable D9-1: Data Management Plan, version 2.0, Janvier 2023 (20 pages), https://doi.org/10.5281/zenodo.7540986

Events

I-Biolex, 1st Project Meeting, Faculté de droit d’Aix, 8 décembre 2021, Aix-en-Provence, France.

I-Biolex, 2nd Project Meeting and 1st SAG Meeting, Faculté de droit d’Aix, 21-22 mars 2022, Aix-en-Provence, France.

T HERVEY, K. FIERLBECK, Public Health Reform, City, University of London, June 2022.

T HERVEY, EU Health Law, latest developments, The City Law School, June 2022.

T HERVEY, O. BARTLETT, EU Health Law, developments post-Covid-19, (with) Maynooth School of Law and Criminology, June 2023.

A. MAHALATCHIMY, X. MAGNON, M. GLINEL (Coords.), Definitions and regulatory concepts in Biolaw, I-BioLex Workshop, Faculté de droit d’Aix, 9 avril 2024, Aix-en-Provence, France.

I-BioLex, 3rd Project Meeting and 2nd SAG Meeting, Faculté de droit d’Aix, 10-11 avril 2024, Aix-en-Provence, France.

É. GENNET, M. FLEAR, A. MAHALATCHIMY and T. HERVEY (Coords.), Framing EU Health Law through Connectivity, I-BioLex in collaboration with UK-FR Partnership “European Union Health Law and Policy” (PI: M. Flear), and E. Gennet’s Junior Professor chair in European Health law and Medicines, Faculté de droit d’Aix, 31 mai 2024, Aix-en-Provence, France.

T HERVEY, K. FIERLBECK, The Contours of Pharmaceutical Regulation in the EU , City, University of London, 11 June 2024.

A. MAHALATCHIMY, Workshop « Fragmentation and defragmentation of the law on biomedical innovations », 30 & 31 October 2025, Amsterdam, the Netherlands.

Other

A. MAHALATCHIMY, M. MBENGUE, E. GENNET, L.-S. GILBERT, E. HABIB, B. BARTOS, M. PERRON, Carnet de recherche « ELSIBI : Ethical, Legal and Social Implications of Biomedical Innovations”: https://elsibi.hypotheses.org/ (accessible à tous depuis juin 2021, et référencé par la Bibliothèque Universitaire d’Aix-Marseille Université)

A. MAHALATCHIMY, Advanced Therapy Medicinal Products, Law in Science , a Podcast by Dr. Inesa Fausch, on Spotify, 6 May 2024.

T HERVEY (propos recueillis par A. MAHALATCHIMY), ‘EU Health Law in the UK: from the past to the present and into the future’, Confluence des droits: La revue [En ligne], 06 | 2024, mis en ligne le 14 juin 2024. URL : https://confluencedesdroits-larevue.com/?p=3591.

Under review or In press

E. RIAL-SEBBAG, A. MAHALATCHIMY, “Tissu/Cellule d’origine humaine”, in C. BYK, Dictionnaire francophone des mots de la bioéthique (ACCEPTE).

B. JUILLARD-CONDAT, A. MAHALATCHIMY, Pharmacovigilance, in S. GARBEN, L. GORMLEY, OUP Online Encyclopedia of EU Law, [OEEUL], 2026. (In Press)

M. A. LITHOPOULOS, A. MAHALATCHIMY, A. ZARZECZNY, Governance of secretome- and extracellular vesicle-based therapies in Canada and in the European Union: state of the art, challenges, and opportunities for protecting patients, Medical Law International (SOUMIS)

A. MAHALATCHIMY, C. CHABANNON, V. BRUNEL, J. VERAN, F. SABATIER, M. MORRISON, Contributions to EU guidance on Biological medicines: proving the dynamics of influence, Therapeutic Innovation & Regulatory Science, (SOUMIS)

V. BRUNEL, V. ROBY, M. MORRISON, A. MAHALATCHIMY, Mapping EU biological medicines’ regulatory guidance through contributors and documents (1990/2025), Scientific data, 2026 (SOUMIS 2026)

Anil Kumar Deshantri, Simone Punt, Ganesh Ramesh, Aiko Ballardini, Emma Martinez Sanchez, Jesus Fernandez-Sojo, Sergi Quero, Zsolt Sebestyen, Julio Delgado, Manel Juan, Ulrike Köhl, Stephan Mielke, Marion Subklewe, Anna Sureda, Tuula Rintala, Martin Dreyling, Chiara Bonini, Eric Vivier, Claire Roddie Michael Hudecek, Carmen Sanges, Ruud Das, Simona Pagliuca, Florent Malard, Jorinde D Hoogenboom, Jarl Mooyaart, Aurélie Mahalatchimy, Christian Chabannon, Annalisa Ruggeri, Trudy Straetemans, Jurgen Kuball, Bridging the Capacity Gap in Advanced Therapies, Nature Reviews Drug Discovery, 2026 (En preparation 2026)

M. MOURBY, O. ANSORGE, I. A. IDIAKEZ, R. ISASI, A. MAHALATCHIMY, J. MAUSBACH, S. STERCKX, G. MAWHINNEY, J. KAYE, Dynamic Consent for Post-Mortem Tissue Donation: an International Review, Medical Law International (En preparation 2026)