Luc-Sylvain Gilbert

Publications

Article de blog scientifique (20)

Bonnes Pratiques de Fabrication des médicaments de thérapie innovante Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2025 Article de blog scientifique halshs-04913820v1
Prix et prise en charge des médicaments en France : Introduction et parties prenantes Audrey-Claire Ruiz,Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Article de blog scientifique halshs-04842473v1
Dossier de demande d'autorisation de mise sur le marché pour les médicaments de thérapie innovante Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Article de blog scientifique halshs-04669909v1
Accès au marché pour les médicaments de thérapie innovante/ Accélération des Procédures d'autorisation de mise sur le marché Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Article de blog scientifique halshs-04842376v1
Autorisation de fabrication des médicaments de thérapie innovante Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Article de blog scientifique halshs-04669913v1
Manufacturing Authorisation of ATMPs Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Article de blog scientifique halshs-04669912v1
Good Manufacturing Practice for ATMPs Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Article de blog scientifique halshs-04669915v1
Emballage et étiquetage des médicaments de thérapie innovante Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Article de blog scientifique halshs-04669910v1
Procédure centralisée pour les médicaments de thérapie innovante Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Article de blog scientifique halshs-04669908v1
Autorisation de mise sur le marché conditionnelle les médicaments de thérapie innovante Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Article de blog scientifique halshs-04669916v1
Autorisation de mise sur le marché sous circonstances exceptionnelles des médicaments de thérapie innovante Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Article de blog scientifique halshs-04846507v1
Procédure d’évaluation accélérée des médicaments de thérapie innovante Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Article de blog scientifique halshs-04842395v1
Market Access for ATMPs- Expediting marketing authorisation pathways Aurélie Mahalatchimy,Luc-Sylvain Gilbert 2023 Article de blog scientifique halshs-04289949v1
Conditional Marketing Authorisation of ATMPs Aurélie Mahalatchimy,Luc-Sylvain Gilbert 2023 Article de blog scientifique halshs-04289972v1
Marketing Authorisation under exceptional circumstances for ATMPs Aurélie Mahalatchimy,Luc-Sylvain Gilbert 2023 Article de blog scientifique halshs-04289984v1
Market Access for ATMPs- Specificities of the marketing authorisation dossier for biosimilars Aurélie Mahalatchimy,Luc-Sylvain Gilbert 2023 Article de blog scientifique halshs-04290000v1
Accelerated Assessment of ATMPs Aurélie Mahalatchimy,Luc-Sylvain Gilbert 2023 Article de blog scientifique halshs-04289991v1
Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure/ Marketing Authorisation Application file Aurélie Mahalatchimy,Luc-Sylvain Gilbert 2022 Article de blog scientifique halshs-03901181v1
Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure Aurélie Mahalatchimy,Luc-Sylvain Gilbert 2022 Article de blog scientifique halshs-03901157v1
Packaging and labelling of ATMPs Aurélie Mahalatchimy,Luc-Sylvain Gilbert 2022 Article de blog scientifique halshs-04289930v1

Rapport (9)

EuroGCT Deliverable D2.9: Update on Research and Regulatory Hub Hsin-Yu Kuo,Aurélie Mahalatchimy,Luc-Sylvain Gilbert,Auxane Delage,Valentin Robyet al. Commission Européeenne. 2025, pp.1-16 Rapport halshs-04930218v1
EuroGCT Deliverable D4.3: Searchable map, Report on development of a searchable map of cell and gene-based therapy activity in Europe Hsin-Yu Kuo,Aurélie Mahalatchimy,Luc-Sylvain Gilbert,Auxane Delage,Valentin Robyet al. Commission Européeenne. 2025, pp.1-12 Rapport halshs-04930206v1
EuroGCT D4-1: Landscape mapping, report on mapping of European cell and gene therapy landscape at multiple levels Aurélie Mahalatchimy,Hsin-Yu Kuo,Luc-Sylvain Gilbert,Auxane Delage,Clare Blackburn European Commission - CORDIS. 2023, https://cordis.europa.eu/project/id/965241/results Rapport halshs-04290642v1
EuroGCT D4-2: Resources on practical steps- a set of information resources on the practical steps needed for cell and gene therapy development Hsin-Yu Kuo,Aurélie Mahalatchimy,Luc-Sylvain Gilbert,Auxane Delage,Clare Blackburn European Commission - CORDIS. 2023, https://cordis.europa.eu/project/id/965241/results Rapport halshs-04290639v1
EuroGCT Deliverable D4.7: Information collation, report on collation of existing information and links on where to seek information and guidance- Version 2.0 Hsin-Yu Kuo,Luc-Sylvain Gilbert,Auxane Delage,Anna Couturier,Aurélie Mahalatchimy European Commission - CORDIS. 2023, https://cordis.europa.eu/project/id/965241/results Rapport halshs-04290644v1
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 Aurélie Mahalatchimy,Auxane Delage,Luc-Sylvain Gilbert,Hsin-Yu Kuo,Anna Couturieret al. European Commission - CORDIS. 2023, https://cordis.europa.eu/project/id/965241/results Rapport halshs-04290634v1
EuroGCT Deliverable D4. 8: Initial landscape mapping Edouard Habib,Luc-Sylvain Gilbert,Amanda Waite,Aurélie Mahalatchimy [Research Report] Commission Européenne. 2022, pp.1-86 Rapport halshs-03780332v1
EuroGCT Deliverable D4.4: Regulator Engagement Strategy Luc-Sylvain Gilbert,Edouard Habib,Amanda Waite,Aurélie Mahalatchimy [Research Report] European Commission. 2022, pp.1-59 Rapport halshs-03780324v1
EuroGCT Deliverable D4.7: Information collation Edouard Habib,Luc-Sylvain Gilbert,Hsin-Yu Kuo,Éloïse Gennet,Aurélie Mahalatchimyet al. [Research Report] Commission Européeenne. 2022, pp.1-87 Rapport halshs-03780340v1

Traduction (4)

Utilisation abusive / détournée des données Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Traduction halshs-04842494v1
Autorités de protection des données Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Traduction halshs-04842512v1
Principes fondamentaux de la protection des données Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Traduction halshs-04842521v1
Classification des données Luc-Sylvain Gilbert,Aurélie Mahalatchimy 2024 Traduction halshs-04842503v1

Poster de conférence (7)

Expediting marketing authorization pathways for patients’ access to advanced therapies Valentin Roby,Luc-Sylvain Gilbert,Valentin Brunel,Auxane Delage,Aurélie Mahalatchimy European Association of Health Law 2024, Sep 2024, Warsaw, Poland Poster de conférence halshs-04842656v1
Real access to ATMPs: the cost issue Aurélie Mahalatchimy,Auxane Delage,Luc-Sylvain Gilbert,Hsin-Yu Kuo,Valentin Robyet al. European Society of Gene & Cell Therapy 2024, Oct 2024, Rome, Italy Poster de conférence halshs-04842702v1
The challenges of Advanced Therapy Medicinal Products manufacturing in the European Union: Strengths and limits of current regulatory tools Luc-Sylvain Gilbert,Auxane Delage,Hsin-Yu Kuo,Anna Couturier,Aurélie Mahalatchimy European Society for Gene & Cell Therapy Congress 2023, Oct 2023, Bruxelles (BEL), Belgium Poster de conférence halshs-04290578v1
Illustrating regulatory requirements for the development of Gene and Cell therapy products with the EuroGCT research pathways Auxane Delage,Luc-Sylvain Gilbert,Hsin-Yu Kuo,Jennifer Lorigan,Clare Blackburnet al. European Society for Blood and Marrow Transplant 49th annual meeting, Apr 2023, Paris, France Poster de conférence halshs-04290303v1
Mapping regulators’ early interactions procedures to support innovation Auxane Delage,Luc-Sylvain Gilbert,Hsin-Yu Kuo,Anna Couturier,Aurélie Mahalatchimy European Society for Gene & Cell Therapy Congress 2023, Oct 2023, Bruxelles (BEL), Belgium Poster de conférence halshs-04290584v1
The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European Union Aurélie Mahalatchimy,Luc-Sylvain Gilbert,Auxane Delage,Olivier Nègre International Society for Cell & Gene Therapy 2023 Annual Meeting, May 2023, Paris Palais des congrès, France. Abstract published in Cytotherapy, 25 (6 Supplement), pp.S160-S161, 2023 Poster de conférence halshs-04290539v1
Bringing gene and cell therapies from lab to patients: the EuroGCT research pathways Auxane Delage,Luc-Sylvain Gilbert,Hsin-Yu Kuo,Jennifer Lorigan,Clare Blackburnet al. European Society for Gene & Cell Therapy Congress 2022, Oct 2022, Edinburgh, United Kingdom Poster de conférence halshs-03901227v1

Communication dans un congrès (1)

The EuroGCT project and the potential involvement of EAHL members Luc-Sylvain Gilbert,Edouard Habib,Aurélie Mahalatchimy Meeting of the EAHL Interest Group on Supranational Biolaw, Annual Conference of the European Association of Health Law, 20-22 April 2022, Apr 2022, Ghent, Belgium Communication dans un congrès halshs-03779362v1