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Outputs

EuroGCT Regulatory Sessions

  1. GMOs- based ATMPs: current regulatory challenges in clinical trial applications and perspectives, EuroGCT Regulatory Roundtable, ESGCT 2023, 25 October 2023, Brussels, Belgium. Chairs: Aurélie Mahalatchimy and Martina Schuessler-Lenz; Administrative Coordinator: Auxane Delage.
  2. Policy and regulatory strategies: current and prospective impact on gene and cell therapy development,  EuroGCT Lunchtime Symposium, ESGCT 2025, 10 October 2025, Sevilla, Spain. Chair: Aurélie Mahalatchimy ; Administrative Coordinator: Auxane Delage.
  3. Is the EU Regulation on HTA Enhancing Equitable Access to Innovative Medicines in Europe? A EuroGCT workshop, Building Bridges for Medicines Justice, 29 October 2025, Amsterdam, The Netherlands. Chair: Aurélie Mahalatchimy ; Administrative Coordinator: Valentin Roby.

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

Chapters

  1. 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.

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.
  6.  A. MAHALATCHIMY, T.K. HERVEY, “Medicines”, in S. GARBEN, L. GORMLEY, The Oxford Encyclopedia of EU Law [OEEUL], February 2025.
  7. I. FAUSCH, A. MAHALATCHIMY, “Advanced Therapy Medicinal products”, in S. GARBEN, L. GORMLEY, The Oxford Encyclopedia of EU Law [OEEUL], February 2025.
  8. B. JUILLARD-CONDAT, A. MAHALATCHIMY, “Pharmacovigilance“, in S. GARBEN, L. GORMLEY, OUP Online Encyclopedia of EU Law, [OEEUL], June 2026.

Oral presentations

  1. 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.
  2. 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).
  3. 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).
  4. A. MAHALATCHIMY, Les spécificités règlementaires des essais cliniques pour les médicaments innovants, GT3M- Séminaire « Essais cliniques »- 13 avril 2023- Marseille, France (Invited).
  5. 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).
  6. 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).
  7. 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).
  8. 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).
  9. 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.
  10. 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).
  11. 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).
  12. A. MAHALATCHIMY, La recherche sur l’embryon et les cellules souches embryonnaires, Conférence de l’Université Pour Tous-Cahors, 8 Février 2024, (Invited).
  13. A. MAHALATCHIMY, Roundtable on “Accelerating Cell and Gene Therapy Innovation: Regulatory Pathways in Europe”, Advanced Therapies Europe 2024, Estoril, Portugal, 10-12 September 2024.
  14. 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.
  15. A. COUTURIER, V. ROBY, A. MAHALATCHIMY, Wide communication of research results: The EuroGCT project, Workshop: Fragmentation and defragmentation of the law on biomedical innovations, University of Amsterdam, 30-31 October 2025, Amsterdam, The Netherlands.
  16. 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 (Invited).
  17. 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 (Invited).
  18. 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. (Invited)

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. MAHALATCHIMY, A. 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.
  13. 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).
  14. 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).
  15. 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)
  16. A. MAHALATCHIMY, H.-Y. KUO, H. LOVE, L.-S. GILBERT, A. DELAGE, V. ROBY, A. COUTURIER, C. BLACKBURN, A stronger European voice to support gene and cell therapies: EuroGCT as a common tool, 52nd EBMT Annual Meeting, 22-25 March 2026, Madrid, Spain. (POSTER)
  17. 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)
  18. 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)
  19. 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)
  20. 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)
  21. 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).

Glossary on EuroGCT’s website

A. MAHALATCHIMY, A. BOTTACCI, A. COUTURIER, A. DELAGE, L-S GILBERT, H. LOVE and V. ROBY, Glossary of terms, March 2025.

  • Creation of legal definitions
  • Publication on the website by A.DELAGE, H. LOVE and V.ROBY

Actors and Networks database on EuroGCT’s website

A. MAHALATCHIMY, A. BOTTACCI, A. COUTURIER, A. DELAGE, L-S GILBERT, H-Y KUO and V. ROBY, Actors and Networks database, March 2025.

  • Classification of the legal actors in the database
  • Lists of legal actors for each categories
  • Publication of the results on the website by H-Y KUO and V. ROBY.

General overviews on EuroGCT’s website

  1. E. GENNET and A. MAHALATCHIMY, ATMPs/ ATMPs and Orphan medicinal products, General overview, April 2023, EuroGCT website.
  2. A. MAHALATCHIMY, Human body elements for therapeutic applications, General overview, July 2023, EuroGCT website.
  3. L.-S. GILBERT and A. MAHALATCHIMY, Manufacturing Authorisation, General overview, January 2023, EuroGCT website.
  4. L.-S. GILBERT and A. MAHALATCHIMY, Good Manufacturing Practice, General overview, April 2023, EuroGCT website.

Entries and pages on EuroGCT’s website

Entries

  1. L.-S. GILBERT and A. MAHALATCHIMY, Packaging and Labelling, November 2022, EuroGCT website.
  2. L.-S. GILBERT and A. MAHALATCHIMY, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure, November 2022, EuroGCT website.
  3. L.-S. GILBERT and A. MAHALATCHIMY, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure/ Marketing Authorisation Application file, November 2022, EuroGCT website.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. O. NEGRE, Translational Science, April 2023, EuroGCT website.
  9. 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.
  10. A. DELAGE and A. MAHALATCHIMY, Early interactions with regulators/ Support specific to ATMPs’ development at EMA level, August 2023, EuroGCT website.
  11. A. MAHALATCHIMY, Commercialisation: Advertising of ATMPs, July 2023, EuroGCT website.
  12. V. L. RAPOSO and T. DE BRITO PAULO, Data Protection/ Data Classification, March 2023, EuroGCT website.
  13. V. L. RAPOSO and T. DE BRITO PAULO, Data Protection/ Data Protection Main Principles, March 2023, EuroGCT website.
  14. V. L. RAPOSO and T. DE BRITO PAULO, Data Protection/ Data Protection Authorities, March 2023, EuroGCT website.
  15. G. CHASSANG and L. FERIOL, Data collection, processing, controlling, March 2023, EuroGCT website.
  16. G. CHASSANG and L. FERIOL, Data sharing / Open data, April 2023, EuroGCT website.
  17. P. LEAN LAU, Mission creep / data misuse, June 2023, EuroGCT website.
  18. L.-S. GILBERT and A. MAHALATCHIMY, Manufacturing Authorisation, June 2024, EuroGCT website.
  19. A. MAHALATCHIMY, “Compassionate use” and “named-patients basis” pathways for ATMPs, November 2024, EuroGCT website.
  20. A. DELAGE and A. MAHALATCHIMY, CAT scientific recommendations on classification, December 2024, EuroGCT website.
  21. A. MAHALATCHIMY and C. CHABANNON, ATMPs specific “Hospital exemption” pathway, January 2025, EuroGCT website.
  22. M. CHAUVEAU SARLANDIE DE LA ROBERTIE, A. PODLIESNYI, L. CAVAREC, M. BRIMPARI, O. NÈGRE , Manufacturing & Controls for Advanced Therapy Medicinal Products, September 2025, EuroGCT website.
  23. O. NÈGRE  and M. BRIMPARI, Non-clinical models for Cell & Gene Therapies, October 2025, EuroGCT website.
  24. A. DELAGE and A. MAHALATCHIMY, Support from several competent authorities for the development of innovative medicines, January 2026, EuroGCT website.
  25. A. DELAGE and A. MAHALATCHIMY, Support from National medicines Agencies for the development of innovative medicines at the National levels, February 2026, EuroGCT website.
  26. A. MAHALATCHIMY and L.-S. GILBERT, Genetically Modified Organisms-Based Advanced Therapy Me-dicinal Products, March 2026, EuroGCT website.
  27. I. FAUSCH, Intellectual Property Rights: Patentability, March 2026, EuroGCT website.
  28. N. DUBRUEL, A. MAHALATCHIMY, In silico studies, April 2026, EuroGCT website.
  29. A. MAHALATCHIMY, Human body elements for human applications / EU Regulation 2024/1938 on substances of human origin intended for human application, April 2026, EuroGCT website.
  30. L.-S. GILBERT, E. HABIB, A. MAHALATCHIMY, Clinical Trials for ATMPs, May 2026, EuroGCT website.
  31. A. MAHALATCHIMY, L.-S. GILBERT, Pharmacovigilance of ATMPs, May 2026, EuroGCT website.
  32. V. ROBY, A. MAHALATCHIMY, Medical devices containing human cells or tissues/SoHO, EuroGCT website, May 2026.
  33. V. ROBY, A. MAHALATCHIMY, Medical devices containing animal cells or tissues, EuroGCT website, May 2026.
  34. A. MAHALATCHIMY, Forthcoming legislative changes at the European Union level and their potential impact on gene and cell therapy, May 2026, EuroGCT website.

Introduction/Transitions pages

  1. L.-S. GILBERT and A. MAHALATCHIMY, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure/ Expediting marketing authorisation pathways, January 2023, EuroGCT website.
  2. A. DELAGE and A. MAHALATCHIMY, Early interactions with regulators, July 2023, EuroGCT website.
  3. A. DELAGE and A. MAHALATCHIMY, Early interactions with regulators/ Support for (innovative) medicines development, July 2023, EuroGCT website.
  4. A. MAHALATCHIMY, ATMPs: Applicable regulatory pathways, May 2024, EuroGCT website.
  5. V. ROBY and A. MAHALATCHIMY, Data, Introduction paragraph for the data entries, November 2024, EuroGCT website.
  6. V. ROBY and A. MAHALATCHIMY, Medical devices containing tissues and cells, December 2024, EuroGCT website.

French version entries on EuroGCT’s website

Entries

  1. L.-S. GILBERT and A. MAHALATCHIMY, Procédure centralisée pour les médicaments de thérapie innovante, January 2024, EuroGCT website.
  2. L.-S. GILBERT and A. MAHALATCHIMY, Dossier de demande d’autorisation de mise sur le marché pour les médicaments de thérapie innovante, January 2024, EuroGCT website.
  3. L.-S. GILBERT and A. MAHALATCHIMY, Emballage et étiquetage des médicaments de thérapie innovante, January 2024, EuroGCT website.
  4. L.-S. GILBERT and A. MAHALATCHIMY, Autorisation de mise sur le marché conditionnelle les médicaments de thérapie innovante, January 2024, EuroGCT website.
  5. L.-S. GILBERT and A. MAHALATCHIMY, Autorisation de mise sur le marché sous circonstances exceptionnelles des médicaments de thérapie innovante, March 2024, EuroGCT website.
  6. L.-S. GILBERT and A. MAHALATCHIMY, Procédure d’évaluation accélérée des médicaments de thérapie innovante, May 2024, EuroGCT website.
  7. L.-S. GILBERT and A. MAHALATCHIMY, Autorisation de fabrication des médicaments de thérapie innovante, June 2024, EuroGCT website
  8. A.-C. RUIZ, L.-S. GILBERT and A. MAHALATCHIMY, Prix et prise en charge des médicaments en France : Introduction, Définitions et Parties Prenantes, August 2024, EuroGCT website.
  9. L.-S. GILBERT and A. MAHALATCHIMY, Accélération des Procédures d’autorisation de mise sur le marché, October 2024, EuroGCT Website.
  10. L.-S. GILBERT and A. MAHALATCHIMY, Bonnes Pratiques de Fabrication des médicaments de thérapie innovante, January 2025, EuroGCT website.
  11. A. BOTTACCI and A. MAHALATCHIMY, Les recherches sur les collections d’échantillons biologiques humains: la place centrale des biobanques, May 2026, EuroGCT website.
  12. V. ROBY and A. MAHALATCHIMY, Obligations applicables au fabricant de dispositifs médicaux, May 2026, EuroGCT website.

Introduction/Transitions pages

  1. L.-S. GILBERT and A. MAHALATCHIMY, Accès au marché pour les médicaments de thérapie innovante, August 2024, EuroGCT website.
  2. V. ROBY and A. MAHALATCHIMY, Données, paragraphe d’introduction pour les entrées données, November 2024, EuroGCT website.

Other

  1. Stratégies politiques et réglementaires : impact actuel et futur sur le développement de la thérapie génique et cellulaire, November 2025, EuroGCT website.

Translations of full entries on EuroGCT’s website

  • In English

  1. A.-C. RUIZ, L.-S. GILBERT and A. MAHALATCHIMY, Medicine pricing and reimbursement in France: introduction, definitions, and key players, translated by L.-S. GILBERT and A. MAHALATCHIMY, May 2026, EuroGCT website.
  2. V. ROBY, A. MAHALATCHIMY, Obligations applicable to medical device manufacturers, translated by V. ROBY and A. MAHALATCHIMY, May 2026, EuroGCT website.

  • In French

Entries

  1. 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, April 2024, EuroGCT website.
  2. 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, April 2024, EuroGCT website.
  3. P. LEAN LAU, Utilisation abusive / détournée des données, translated by L.-S. GILBERT and A. MAHALATCHIMY, August 2024, EuroGCT website.
  4. O. NEGRE, Science Translationnelle, translated by L.-S. GILBERT and O. NEGRE, September 2024, EuroGCT website.
  5. V. L. RAPOSO and T. DE BRITO PAULO, Classification des données, translated by L.-S. GILBERT and A. MAHALATCHIMY, October 2024, EuroGCT website.
  6. V. L. RAPOSO and T. DE BRITO PAULO, Autorités de protection des données, translated by L.-S. GILBERT and A. MAHALATCHIMY, October 2024, EuroGCT website.
  7. V. L. RAPOSO and T. DE BRITO PAULO, Principes fondamentaux de la protection des données, translated by L.-S. GILBERT and A. MAHALATCHIMY, October 2024, EuroGCT website.
  8. A. MAHALATCHIMY, Publicité concernant les MTI, translated by V. BURAKOVA LORGNIER, L.-S. GILBERT and A. MAHALATCHIMY, March 2025, EuroGCT website.
  9. A. DELAGE and A. MAHALATCHIMY, Soutien spécifique au développement des MTI au niveau de l’EMA, translated by V. BURAKOVA LORGNIER, A. DELAGE and A. MAHALATCHIMY, April 2025, EuroGCT website.
  10. E. GENNET and A. MAHALATCHIMY, MTI et médicaments orphelins, translated by V. BURAKOVA LORGNIER, April 2025, EuroGCT website.
  11. A. MAHALATCHIMY and C. CHABANNON, Le parcours de l'”Exemption hospitalière” spécifique aux MTI, translated by V. BURAKOVA LORGNIER and A. MAHALATCHIMY, April 2025, EuroGCT website.
  12. A. MAHALATCHIMY, Les parcours MTI de l’“usage compassionnel” et sur base nominative (“named-patients basis”), translated by V. BURAKOVA LORGNIER and A. MAHALATCHIMY, April 2025, EuroGCT website.
  13. CHAUVEAU SARLANDIE DE LA ROBERTIE, A. PODLIESNYI, L. CAVAREC, M. BRIMPARI, O. NEGRE, Fabrication et contrôles pour Médicaments de Thérapie Innovante, translated by L.-S. GILBERT, O. NEGRE and A. MAHALATCHIMY, October 2025, EuroGCT website.
  14. A. DELAGE and A. MAHALATCHIMY, Recommandations scientifiques du CAT en matière de classification en tant que thérapie innovante, translated by V. BURAKOVA LORGNIER, L.-S. GILBERT and A. MAHALATCHIMY, November 2025, EuroGCT website.
  15. A. DELAGE and A. MAHALATCHIMY, Soutien au développement de médicaments innovants au niveau de l’EMA, translated by V. BURAKOVA LORGNIER, L.-S. GILBERT and A. MAHALATCHIMY, November 2025, EuroGCT website.
  16. L.-S. GILBERT et O. NEGRE, Traduction de l’anglais au français, Modèles non cliniques pour les thérapies cellulaires et géniques, janvier 2026, EuroGCT website, à partir de Olivier Nègre et Minodora Brimpari, Non-clinical models for Cell & Gene Therapies, October 2025, EuroGCT website.
  17. V. BURAKOVA-LORGNIER et A. MAHALATCHIMY, Traduction de l’anglais au français, Soutien de plusieurs autorités compétentes en faveur du développement de médicaments innovants, avril 2026, EuroGCT website, à partir de A. DELAGE et A. MAHALATCHIMY, Support from several competent authorities for the development of innovative medecines, January 2026, EuroGCT website.
  18. N. DUBRUEL, traduction de l’anglais au français Études in silico (modèles numériques / jumeaux), Mai 2026, à partir de N. DUBRUEL et A. MAHALATCHIMY, In silico studies (digital models/digital twins), April 2026.
  19. V. ROBY et A. MAHALATCHIMY, traduction de l’anglais au français, Dispositifs médicaux contenant des tissus et cellules d’origine humaine/SoHO, Mai 2026, à partir de V. ROBY et A. MAHALATCHIMY, Medical devices using human tissues and cells/SoHO, Mai 2026.
  20. V. ROBY et A. MAHALATCHIMY, traduction de l’anglais au français, Dispositifs médicaux contenant des tissus et cellules d’origine animale, Mai 2026, à partir de V. ROBY et A. MAHALATCHIMY, Medical devices using animal tissues and cells, Mai 2026.

Introduction/Transitions pages

  1. H.-Y KUO, Recherche et innovation, translated by V. BURAKOVA LORGNIER, L.-S. GILBERT and A. MAHALATCHIMY, March 2025, EuroGCT website.
  2. H.-Y KUO, Commercialisation, translated by V. BURAKOVA LORGNIER, L.-S. GILBERT and A. MAHALATCHIMY, March 2025, EuroGCT website.
  3. H.Y KUO, Implication du public et Données, translated by V.BURAKOVA LORGNIER, L.-S. GILBERT and A. MAHALATCHIMY, March 2025, EuroGCT website.
  4. A. DELAGE and A. MAHALATCHIMY, Soutien au développement de médicaments innovants, translated by V. BURAKOVA LORGNIER, V. ROBY and A. MAHALATCHIMY, April 2025, EuroGCT website.
  5. H.-Y KUO, Fabrication, translated by V.BURAKOVA LORGNIER, L.-S. GILBERT and A. MAHALATCHIMY, May 2025, EuroGCT website.
  6. H.-Y KUO, Classification des thérapies, translated by V. BURAKOVA-LORGNIER and A. MAHALATCHIMY, May 2025, EuroGCT website.
  7. A. MAHALATCHIMY, MTI : Voies réglementaires applicables, translated by V. BURAKOVA LORGNIER and A. MAHALATCHIMY, May 2025, EuroGCT website.
  8. A. DELAGE and A. MAHALATCHIMY, Interactions précoces avec les autorités règlementaires, translated by V. BURAKOVA-LORGNIER and A. MAHALATCHIMY, May 2025, EuroGCT website.
  9. Section Littérature Pertinente des Ressources clés EuroGCT À propos des Ressources Clés d’EuroGCT, translated by V. BURAKOVA LORGNIER and A. MAHALATCHIMY, May 2025, EuroGCT website.
  10. À propos des Ressources Clés d’EuroGCT, translated by V. BURAKOVA LORGNIER and A. MAHALATCHIMY, June 2025, EuroGCT website.
  11. Qui sont les destinataires des Ressources clés EuroGCT, et comment les utiliser ?, translated by V. BURAKOVA LORGNIER and A. MAHALATCHIMY, June 2025, EuroGCT website.
  12. Mode d’emploi du “Parcours de développement”, translated by V. BURAKOVA LORGNIER and A. MAHALATCHIMY, June 2025, EuroGCT website.
  13. Base de données Acteurs et réseaux, translated by V. BURAKOVA LORGNIER and  MAHALATCHIMY, November 2025, EuroGCT website.
  14. V. ROBY et A. MAHALATCHIMY, Dispositifs médicaux incorporant des cellules ou tissus, translated by V. ROBY et A. MAHALATCHIMY, May 2026, EuroGCT website.

Other

  1. Stratégies politiques et réglementaires : impact actuel et futur sur le développement de la thérapie génique et cellulaire, translated by V. BURAKOVA-LORGNIER, November 2025, EuroGCT website.

  • In Italian

Entries

  1. O. NEGRE, Medicina traslazionale, translated by V. BURAKOVA LORGNIER, March 2025, EuroGCT website.
  2. A. DELAGE and A. MAHALATCHIMY, Sostegno allo sviluppo di farmaci innovativi a livello EMA, Translated by V. BURAKOVA LORGNIER, March 2025, EuroGCT website.
  3. L-S. GILBERT and A. MAHALATCHIMY, Procedura centralizzata per i medicinali per terapie avanzate, translated by V.BURAKOVA LORGNIER, March 2025, EuroGCT website.
  4. L-S. GILBERT and A. MAHALATCHIMY, Dossier della domanda di autorizzazione all’immissione in commercio per gli MTA, translated by V.BURAKOVA LORGNIER, March 2025,  EuroGCT website.
  5. L-S. GILBERT and A. MAHALATCHIMY, Autorizzazione all’immissione in commercio condizionata per i medicinali per terapie avanzate, translated by V.BURAKOVA LORGNIER, March 2025, EuroGCT website.
  6. A. MAHALATCHIMY, Pubblicità dei MTA, translated by V.BURAKOVA LORGNIER, March 2025, EuroGCT website.
  7. V. L. RAPOSO and T. DE BRITO PAULO, Classificazione dei dati, translated by V.BURAKOVA LORGNIER, March 2025, EuroGCT website.
  8. P. LEAN LAU, Mission creep / Abuso dei dati, translated by V.BURAKOVA LORGNIER, April 2025, EuroGCT website.
  9. L-S. GILBERT and A. MAHALATCHIMY, Autorizzazione alla produzione di medicinali per terapie avanzate, Translated by V.BURAKOVA LORGNIER, April 2025, EuroGCT website.
  10. A. DELAGEand A. MAHALATCHIMY, Sostegno specifico allo sviluppo di ATMP a livello di EMA, Translated by V. BURAKOVA LORGNIER, April 2025, EuroGCT website.
  11. V.L RAPOSO and T. DE BRITO PAULO, Principi fondamentali della protezione dei dati, translated by V.BURAKOVA LORGNIER, April 2025, EuroGCT website.
  12. V.L RAPOSO and T. DE BRITO PAULO, Autorità di protezione dei dati, translated by V.BURAKOVA LORGNIER, April 2025, EuroGCT website.
  13. V.L RAPOSO and T. DE BRITO PAULO, Raccolta, elaborazione e controllo dei dati, translated by V.BURAKOVA LORGNIER, April 2025, EuroGCT website.
  14. V.L RAPOSO and T. DE BRITO PAULO, Condivisione dei dati / Dati aperti, translated by V.BURAKOVA LORGNIER, April 2025, EuroGCT website.
  15. A. DELAGE and A. MAHALATCHIMY, CAT raccomandazioni scientifiche sulla classificazione, translated by V. BURAKOVA LORGNIER, April 2025, EuroGCT website.
  16. E. GENNET and A. MAHALATCHIMY, MTA e medicinali orfani, translated by V. BURAKOVA LORGNIER, April 2025, EuroGCT website.
  17. A. MAHALATCHIMY and C.CHABANNON, Percorso di “Esenzione ospedaliera” specifico per i MTA, translated by V. BURAKOVA LORGNIER and A. MAHALATCHIMY, April 2025, EuroGCT website.
  18. A. MAHALATCHIMY, Percorsi di “uso compassionevole” e “su base nominativa” per i MTA, translated by V. BURAKOVA LORGNIER, May 2025, EuroGCT website.
  19. L-S. GILBERT and A. MAHALATCHIMY, Buone pratiche di fabbricazione per i MTA, translated by V.BURAKOVA LORGNIER, May 2025, EuroGCT website.
  20. L-S. GILBERT and A. MAHALATCHIMY, L’imballaggio e l’etichettatura degli MTA, translated by V.BURAKOVA LORGNIER, May 2025, EuroGCT website.
  21. L-S. GILBERT and A. MAHALATCHIMY, Autorizzazione all’immissione in commercio in circostanze eccezionali per gli MTA, translated by V.BURAKOVA LORGNIER, June 2025,  EuroGCT website.
  22. O. NÈGRE and M. BRIMPARI, Modelli non-clinici per Terapie Cellulari e Geniche, translated by V.BURAKOVA LORGNIER, November 2025, EuroGCT website.
  23. M. CHAUVEAU SARLANDIE DE LA ROBERTIE, A. PODLIESNYI, L. CAVAREC, M. BRIMPARI and O. NEGRE, Produzione e controllo di Medicinali per Terapie Avanzate, translated by V.BURAKOVA LORGNIER, November 2025, EuroGCT website

Introduction/Transitions pages

  1.  Ricerca e innovazione, translated from English by V.BURAKOVA LORGNIER and E. CESTA, March 2025, EuroGCT website.
  2. Commercializzazione, Translated from English by V.BURAKOVA LORGNIER and E. CESTA, March 2025, EuroGCT website.
  3. Dati, translated from English by V.BURAKOVA LORGNIER, March 2025, EuroGCT website.
  4. Protezione dei dati, translated from English by V.BURAKOVA LORGNIER, March 2025, EuroGCT website.
  5. Sostegno allo sviluppo di farmaci innovativi, translated from English by V. BURAKOVA LORGNIER, April 2025, EuroGCT website.
  6. Coinvolgimento del pubblico e Dati, translated from English by V.BURAKOVA LORGNIER and E. CESTA, April 2025, EuroGCT website.
  7. Classificazione delle terapie, translated from English by V.BURAKOVA LORGNIER and E. CESTA, May 2025, EuroGCT website.
  8. Fabbricazione, translated from English by V.BURAKOVA LORGNIER and E. CESTA, May 2025, EuroGCT website.
  9.  Accesso al mercato dei MTA, translated from English by V.BURAKOVA LORGNIER, May 2025, EuroGCT website.
  10.  MTA: Percorsi normativi applicabili, translated from English by V. BURAKOVA LORGNIER, May 2025, EuroGCT website.
  11. Interazione precoce con i regolatori, translated from English by V. BURAKOVA LORGNIER, May 2025, EuroGCT website.
  12. Sezione Letteratura Pertinente delle Risorse Chiave EuroGCT, translated by V.BURAKOVA LORGNIER and E. CESTA, June 2025, EuroGCT website.
  13. Informazioni sulle Risorse chiave EuroGCT, translated by V.BURAKOVA LORGNIER and E. CESTA, June 2025, EuroGCT website.
  14. Chi dovrebbe utilizzare le risorse chiave EuroGCT e come utilizzarle?, translated by V.BURAKOVA LORGNIER and E. CESTA, July 2025, EuroGCT website.
  15. Come utilizzare i Percorsi di ricerca, translated by V.BURAKOVA LORGNIER and E. CESTA, September 2025, EuroGCT website.
  16. Database Attori e Reti, translated by V. BURAKOVA LORGNIER, November 2025, 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).