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Outputs

Articles

M. MORRISON, V. BRUNEL, & A. MAHALATCHIMY, Participation in SoHO and ATMP public consultations: a fragmented institutional landscape. Humanit Soc Sci Commun 12, 262 (2025). https://doi.org/10.1057/s41599-025-04552-1

Notices d’encyclopédies

  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
  2. F. TABOULET, A. MAHALATCHIMY, “Packaging and labelling of medicines”, in S. GARBEN, L. GORMLEY, The Oxford Encylopedia of EU Law [OEEUL], 2022.
  3. F. TABOULET, A. MAHALATCHIMY, “Transparency of medicines pricing”, in S. GARBEN, L. GORMLEY, The Oxford Encylopedia of EU Law [OEEUL], 2022.
  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.
  5. E. GENNET, A. MAHHALATCHIMY, “Orphan Medicines”, in S. GARBEN, L. GORMLEY, The Oxford Encylopedia of EU Law [OEEUL], 2023.

Oral presentations

L.-S. GILBERT, E. HABIB, A. MAHALATCHIMY, The EuroGCT project and the potential involvement of EAHL members, Meeting 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.

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 (Invited).

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 (Invited).

A. MAHALATCHIMY, Les spécificités règlementaires des essais cliniques pour les médicaments innovants, GT3M- Séminaire « Essais cliniques »- 13 avril 2023- Marseille, France (Invited).

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 (Invited).

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 (Invited).

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 (Invited).

A. BOTTACCI et A. MAHALATCHIMY, Quel futur pour le cadre juridique des tissus et des organes destinés à la transplantation ? Le cas des organoïdes, Journée d’étude ITEGOREC- 14 juin 2023- Compiègne (Invited).

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.

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 (Invited).

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 (Invited).

A. MAHALATCHIMY, La recherche sur l’embryon et les cellules souches embryonnaires, Conférence de l’Université Pour Tous-Cahors, 8 Février 2024, (Invited).

A. MAHALATCHIMY, Roundtable on “Accelerating Cell and Gene Therapy Innovation: Regulatory Pathways in Europe”, Advanced Therapies Europe 2024, Estoril, Portugal, 10-12 September 2024.

Posters

  1. A. DELAGE, L.-S. GILBERT, H.-Y. KUO, J. LORIGAN, C. BLACKBURN, A. COUTURIER, A. WAITE, A. MAHALATCHIMY, Bringing gene and cell therapies from lab to patients: the EuroGCT research pathways, European Society for Gene & Cell Therapy Congress 2022, Edinburgh, the UK, 11-14 October 2022.
  2. A. DELAGE, L.-S. GILBERT, H.-Y. KUO, J. LORIGAN, C. BLACKBURN, A. COUTURIER, A. WAITE, A. MAHALATCHIMY, Finding out the regulatory requirements for the development of Gene and Cell therapy products with the EuroGCT research pathways, European Society for Blood and Marrow Transplant 49th annual meeting, Paris, France, 23-26 April 2022.
  3. 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; Abstract published in Cytotherapy Volume 25, Issue 6, Supplement, May 2023, Pages S160–S161.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. V. ROBY, L.-S. GILBERT, V. BRUNEL, A. DELAGE, A. MAHALATCHIMY, The expediting marketing authorisation pathways for patients’ access to advanced therapies, 9th Annual Conference of the European Association of Health Law, Warsaw, Poland, 18-20 September 2024.
  12. A. MAHALATCHIMYA. DELAGE, L.-S. GILBERT, H.-Y. KUO, V. ROBY, C.CHABANNON, Real access to ATMPs : the cost issue, European Society for Gene & Cell Therapy Congress 2024, Roma, Italy, 22-25 October 2024.

General overviews on EuroGCT’s website

E. HABIB and A. MAHALATCHIMY, Clinical research/ Clinical trials, General overview,  April 2023, EuroGCT website.

E. GENNET and A. MAHALATCHIMY, ATMPs/ ATMPs and Orphan medicinal products, General overview, April 2023, EuroGCT website.

A. MAHALATCHIMY, Not ATMPs: Human body elements for therapeutic applications, General overview, July 2023, EuroGCT website.

L.-S. GILBERT and A. MAHALATCHIMY, Manufacturing Authorisation, General overview, January 2023, EuroGCT website.

L.-S. GILBERT and A. MAHALATCHIMY, Good Manufacturing Practice, General overview, April 2023, EuroGCT website.

Entries on EuroGCT’s website

L.-S. GILBERT and A. MAHALATCHIMY, Packaging and Labelling, November 2022, EuroGCT website.

L.-S. GILBERT and A. MAHALATCHIMY, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure, November 2022, EuroGCT website.

L.-S. GILBERT and A. MAHALATCHIMY, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure/ Marketing Authorisation Application file, November 2022, EuroGCT website.

L.-S. GILBERT and A. MAHALATCHIMY, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure/ Specificities of the marketing authorisation dossier for biosimilars, February 2023, EuroGCT website.

L.-S. GILBERT and A. MAHALATCHIMY, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure/ Expediting marketing authorisation pathways, January 2023, EuroGCT website.

L.-S. GILBERT and A. MAHALATCHIMY, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure/ Expediting marketing authorisation pathways/ Conditional Marketing Authorisation, January 2023, EuroGCT website.

L.-S. GILBERT and A. MAHALATCHIMY, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure/ Expediting marketing authorisation pathways/ Marketing Authorisation under exceptional circumstances, January 2023, EuroGCT website.

L.-S. GILBERT and A. MAHALATCHIMY, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure/ Expediting marketing authorisation pathways/ Accelerated Assessment, January 2023, EuroGCT website.

O. NEGRE, Translational Science, April 2023, EuroGCT website.

A. DELAGE and A. MAHALATCHIMY, Early interactions with regulators, July 2023, EuroGCT website.

A. DELAGE and A. MAHALATCHIMY, Early interactions with regulators/ Support for (innovative) medicines development, July 2023, EuroGCT website.

A. DELAGE and A. MAHALATCHIMY, Early interactions with regulators/ Support for (innovative) medicines development/ Support for innovative medicines’ development at the EMA level, July 2023, EuroGCT website.

A. DELAGE and A. MAHALATCHIMY, Early interactions with regulators/ Support specific to ATMPs’ development at EMA level, August 2023, EuroGCT website.

A. MAHALATCHIMY, Commercialisation: Advertising of ATMPs, July 2023, EuroGCT website.

V. L. RAPOSO and T. DE BRITO PAULO, Data Protection/ Data Classification, March 2023, EuroGCT website.

V. L. RAPOSO and T. DE BRITO PAULO, Data Protection/ Data Protection Main Principles, March 2023, EuroGCT website.

V. L. RAPOSO and T. DE BRITO PAULO, Data Protection/ Data Protection Authorities, March 2023, EuroGCT website.

G. CHASSANG and L. FERIOL, Data collection, processing, controlling, March 2023, EuroGCT website.

G. CHASSANG and L. FERIOL, Data sharing / Open data, April 2023, EuroGCT website.

P. LEAN LAU, Mission creep / data misuse, June 2023, EuroGCT website.

L.-S. GILBERT and A. MAHALATCHIMY, Manufacturing Authorisation, juin 2024, EuroGCT website.

A.-C. RUIZ, L.-S. GILBERT and A. MAHALATCHIMY, Prix et prise en charge des médicaments en France, Main actors and definitions, august 2024, EuroGCT website.

A. MAHALATCHIMY, “Compassionate use” and “named-patients basis” pathways for ATMPs, November 2024, EuroGCT website.

V.ROBY and A. MAHALATCHIMY , Data, Introduction paragraph for the data entries, November 2024, EuroGCT website.

A. DELAGE and A. MAHALATCHIMY, CAT scientific recommendations on classification , December 2024, EuroGCT website.

A. MAHALATCHIMY and C. CHABANNON, ATMPs specific “Hospital exemption” pathway, January 2025, EuroGCT website.

French version entries on EuroGCT’s website

L.-S. GILBERT and A. MAHALATCHIMY, Procédure centralisée pour les médicaments de thérapie innovante, janvier 2024, Site EuroGCT.

L.-S. GILBERT and A. MAHALATCHIMY, Dossier de demande d’autorisation de mise sur le marché pour les médicaments de thérapie innovante, janvier 2024, site EuroGCT.

L.-S. GILBERT and A. MAHALATCHIMY, Emballage et étiquetage des médicaments de thérapie innovante, janvier 2024, site EuroGCT.

L.-S. GILBERT and A. MAHALATCHIMY, Autorisation de mise sur le marché conditionnelle les médicaments de thérapie innovante, janvier 2024, site EuroGCT.

L.-S. GILBERT and A. MAHALATCHIMY, Autorisation de mise sur le marché sous circonstances exceptionnelles des médicaments de thérapie innovante, mars 2024, site EuroGCT.

L.-S. GILBERT and A. MAHALATCHIMY, Procédure d’évaluation accélérée des médicaments de thérapie innovante, mai 2024, site EuroGCT.

L.-S. GILBERT and A. MAHALATCHIMY, Autorisation de fabrication des médicaments de thérapie innovante, June 2024, EuroGCT website

 L.-S. GILBERT and A. MAHALATCHIMYAccélération des Procédures d’autorisation de mise sur le marché, Octobre 2024, EuroGCT Website.

V.ROBY and A. MAHALATCHIMY , Données, paragraphe d’introduction pour les entrées données, November 2024, EuroGCT website.

L.-S. GILBERT and A. MAHALATCHIMY, Bonnes Pratiques de Fabrication des médicaments de thérapie innovante, Janvier 2025.

Translations of full entries on EuroGCT’s website

G. CHASSANG and L. FERIOL, Collecte, traitement et contrôle des données, translated by G. CHASSANG and L. FERIOL  and translation reviewed by L.-S. GILBERT, avril 2024, site EuroGCT.

G. CHASSANG and L. FERIOL, Partage des données / Ouverture des données, translated by G. CHASSANG and L. FERIOL and translation reviewed by L.-S. GILBERT, avril 2024, Site EuroGCT.

O. NEGRE, Science Translationnelle, translated by L.-S. GILBERT and O. NEGRE, septembre 2024, EuroGCT website.

V. L. RAPOSO and T. DE BRITO PAULO, Utilisation abusive / détournée des données, translated by L.-S. GILBERT and A. MAHALATCHIMY, août 2024, EuroGCT website.

V. L. RAPOSO and T. DE BRITO PAULO, Classification des données, translated by L.-S. GILBERT and A. MAHALATCHIMY, octobre 2024, EuroGCT website.

V. L. RAPOSO and T. DE BRITO PAULO, Autorités de protection des données, translated by L.-S. GILBERT and A. MAHALATCHIMY, octobre 2024, EuroGCT website.

V. L. RAPOSO and T. DE BRITO PAULO, Principes fondamentaux de la protection des données, translated by L.-S. GILBERT and A. MAHALATCHIMY, octobre 2024, EuroGCT website.

Deliverables

  1. Luc- Sylvain GILBERT, Edouard HABIB, Amanda WAITE, Aurélie MAHALATCHIMY, EuroGCT, Deliverable D4.4: Regulator Engagement Strategy, Janvier 2022 (59 pages dont annexes).
  2. Edouard HABIB, Luc- Sylvain GILBERT, Hsin-Yu KUO, Eloïse GENNET, Amanda WAITE, Aurélie MAHALATCHIMY, EuroGCT, Deliverable D4.7: Information collation, Janvier 2022 (87 pages dont annexes).
  3. Edouard HABIB, Luc- Sylvain GILBERT, Amanda WAITE, Aurélie MAHALATCHIMY, EuroGCT, Deliverable D4. 8: Initial landscape mapping, Janvier 2022 (86 pages dont annexes).
  4. Hsin-Yu KUO, Amanda WAITE, Aurélie MAHALATCHIMY, EuroGCT, Deliverable D4.9: Initial information on practical steps, Janvier 2022 (on Website : https://www.eurogct.org/research-pathways + 7 pages of explanation).
  5. Clare BLACKBURN, Amanda WAITE, Anna COUTURIER, Aurélie MAHALATCHIMY, EuroGCT Periodic Report 2022, May 2022, 103 pages.
  6. MAHALATCHIMY, Auxane DELAGE, Luc- Sylvain GILBERT, Hsin-Yu KUO, Anna COUTURIER, Jennifer LORIGAN, Clare BLACKBURN, EuroGCT, D2-2: Research community hub, a report on dissemination and uptake of information produced in WP4 via the EuroGCT online research and regulatory community hub, 28 July 2023 (27 pages dont annexes).
  7. Hsin-Yu KUO, MAHALATCHIMY, Luc- Sylvain GILBERT, Auxane DELAGE, Clare BLACKBURN, EuroGCT, D4-2: Resources on practical steps- a set of information resources on the practical steps needed for cell and gene therapy development, 31 July 2023 (13 pages).
  8. MAHALATCHIMY, Hsin-Yu KUO, Luc- Sylvain GILBERT, Auxane DELAGE, Clare BLACKBURN, EuroGCT, D4-1: Landscape mapping, report on mapping of European cell and gene therapy landscape at multiple levels, 31 July 2023 (31 pages).
  9. Hsin-Yu KUO, Luc- Sylvain GILBERT, Auxane DELAGE, Anna COUTURIER, Aurélie MAHALATCHIMY, EuroGCT, Deliverable D4.7: Information collation, report on collation of existing information and links on where to seek information and guidance- Version 2.0, 31 July 2023 (91 pages dont annexes).
  10. Hsin-Yu Kuo, Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Auxane Delage, Valentin Roby, Olivier Negre, Clare Blackburn, EuroGCT, Deliverable D.4.3 ; Searchable Map, Report on development of a searchable map of cell and gene-based therapy activity in Europe, 31st January 2025 (12 pages).
  11. Hsin-Yu Kuo, Aurélie Mahalatchimy, Luc- SylvainGilbert, Auxane Delage, Valentin Roby, AnnaCouturier, Jennifer Lorigan, Clare Blackburn, D2.9 Update of Research and Regulatory HubReport on integration of new information to, content updating in and information uptake from the EuroGCT online research and regulatory community hub, 31st January 2025 (16 pages).