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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.

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.

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.

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

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, Les spécificités règlementaires des essais cliniques pour les médicaments innovants, GT3M- Séminaire « Essais cliniques »- 13 avril 2023- Marseille, France.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. A. MAHALATCHIMY, La loi française relative à la bioéthique : évolutions et démocratisation, Conférence de l’Université Pour Tous-Cahors, 16 Février 2023, (Invitée).
  18. A. MAHALATCHIMY, La recherche sur l’embryon et les cellules souches embryonnaires, Conférence de l’Université Pour Tous-Cahors, 8 Février 2024, (Invitée).
  19. 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).
  20. 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.
  21. 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.
  22. 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.
  23. 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.
  24. 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.
  25. X. MAGNON, Conclusions, I-BioLex Workshop « Definitions and regulatory concepts in Biolaw », Faculté de droit d’Aix, 9 avril 2024, Aix-en-Provence, France.
  26. 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.
  27. C. CHABANNON, Le défi des médicaments de thérapie innovante pour l’organisation des CLCC, Santexpo 2024, 22 mai 2024, Paris, France.

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, 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, Saturday 29 July 2023.
  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. 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.
  12. 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.
  13. 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.
  14. 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)
  15. 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)
  16. 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)
  17. 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)
  18. 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)
  19. 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)

Deliverables/ Reports

  1. 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.
  2. 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.
  3. A. MAHALATCHIMY, Compte-rendu Intermédiaire du Projet I-BioLex, Juin 2022, 15 pages.
  4. 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

  1. I-Biolex, 1st Project Meeting, Faculté de droit d’Aix, 8 décembre 2021, Aix-en-Provence, France.
  2. I-Biolex, 2nd Project Meeting and 1st SAG Meeting, Faculté de droit d’Aix, 21-22 mars 2022, Aix-en-Provence, France.
  3. 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.
  4. I-BioLex, 3rd Project Meeting and 2nd SAG Meeting, Faculté de droit d’Aix, 10-11 avril 2024, Aix-en-Provence, France.
  5. 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.

Other

  1. 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)
  2. A. MAHALATCHIMY, Advanced Therapy Medicinal Products, Law in Science , a Podcast by Dr. Inesa Fausch, on Spotify.

Under review or In press

  1. A. MAHALATCHIMY, G. NICOLAS, « Du transhumain au posthumain : quels droits fondamentaux ? », in A. MAHALATCHIMY, G. NICOLAS (Dir.), Transhumanisme : de nouveaux droits ?, Confluence des Droits, (Sous presse).
  2. 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? », Cahiers TESACO 2024, (Sous presse).
  3. A. MAHALATCHIMY, T.K. HERVEY, “Medicines”, in S. GARBEN, L. GORMLEY, The Oxford Encylopedia of EU Law [OEEUL], SOUMIS
  4. I. FAUSCH, A. MAHALATCHIMY, “Advanced Therapy Medicinal products”, in S. GARBEN, L. GORMLEY, The Oxford Encylopedia of EU Law [OEEUL], SOUMIS