Luc-Sylvain Gilbert

41
Documents

Publications

Publications

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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 Roby et al.
Commission Européeenne. 2025, pp.1-12
Rapport halshs-04930206 v1
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EuroGCT Deliverable D2.9: Update on Research and Regulatory Hub

Hsin-Yu Kuo , Aurélie Mahalatchimy , Luc-Sylvain Gilbert , Auxane Delage , Valentin Roby et al.
Commission Européeenne. 2025, pp.1-16
Rapport halshs-04930218 v1
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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-04290644 v1
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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-04290642 v1
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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-04290639 v1
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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 Couturier et al.
European Commission - CORDIS. 2023, https://cordis.europa.eu/project/id/965241/results
Rapport halshs-04290634 v1

EuroGCT Deliverable D4.7: Information collation

Edouard Habib , Luc-Sylvain Gilbert , Hsin-Yu Kuo , Éloïse Gennet , Aurélie Mahalatchimy et al.
[Research Report] Commission Européeenne. 2022, pp.1-87
Rapport halshs-03780340 v1

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-03780324 v1

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-03780332 v1

Bonnes Pratiques de Fabrication des médicaments de thérapie innovante

Luc-Sylvain Gilbert , Aurélie Mahalatchimy
2025
Article de blog scientifique halshs-04913820 v1

Procédure d’évaluation accélérée des médicaments de thérapie innovante

Luc-Sylvain Gilbert , Aurélie Mahalatchimy
2024
Article de blog scientifique halshs-04842395 v1

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-04846507 v1

Autorisation de mise sur le marché conditionnelle les médicaments de thérapie innovante

Luc-Sylvain Gilbert , Aurélie Mahalatchimy
2024
Article de blog scientifique halshs-04669916 v1

Autorisation de fabrication des médicaments de thérapie innovante

Luc-Sylvain Gilbert , Aurélie Mahalatchimy
2024
Article de blog scientifique halshs-04669913 v1

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-04842376 v1

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-04669909 v1

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-04842473 v1

Manufacturing Authorisation of ATMPs

Luc-Sylvain Gilbert , Aurélie Mahalatchimy
2024
Article de blog scientifique halshs-04669912 v1

Emballage et étiquetage des médicaments de thérapie innovante

Luc-Sylvain Gilbert , Aurélie Mahalatchimy
2024
Article de blog scientifique halshs-04669910 v1

Good Manufacturing Practice for ATMPs

Luc-Sylvain Gilbert , Aurélie Mahalatchimy
2024
Article de blog scientifique halshs-04669915 v1

Procédure centralisée pour les médicaments de thérapie innovante

Luc-Sylvain Gilbert , Aurélie Mahalatchimy
2024
Article de blog scientifique halshs-04669908 v1

Conditional Marketing Authorisation of ATMPs

Aurélie Mahalatchimy , Luc-Sylvain Gilbert
2023
Article de blog scientifique halshs-04289972 v1

Market Access for ATMPs- Expediting marketing authorisation pathways

Aurélie Mahalatchimy , Luc-Sylvain Gilbert
2023
Article de blog scientifique halshs-04289949 v1

Market Access for ATMPs- Specificities of the marketing authorisation dossier for biosimilars

Aurélie Mahalatchimy , Luc-Sylvain Gilbert
2023
Article de blog scientifique halshs-04290000 v1

Marketing Authorisation under exceptional circumstances for ATMPs

Aurélie Mahalatchimy , Luc-Sylvain Gilbert
2023
Article de blog scientifique halshs-04289984 v1

Accelerated Assessment of ATMPs

Aurélie Mahalatchimy , Luc-Sylvain Gilbert
2023
Article de blog scientifique halshs-04289991 v1

Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure

Aurélie Mahalatchimy , Luc-Sylvain Gilbert
2022
Article de blog scientifique halshs-03901157 v1

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-03901181 v1

Packaging and labelling of ATMPs

Aurélie Mahalatchimy , Luc-Sylvain Gilbert
2022
Article de blog scientifique halshs-04289930 v1
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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-04842656 v1
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Real access to ATMPs: the cost issue

Aurélie Mahalatchimy , Auxane Delage , Luc-Sylvain Gilbert , Hsin-Yu Kuo , Valentin Roby et al.
European Society of Gene & Cell Therapy 2024, Oct 2024, Rome, Italy
Poster de conférence halshs-04842702 v1
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Finding out the 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 Blackburn et al.
European Society for Blood and Marrow Transplant 49th annual meeting, Apr 2023, Paris, France
Poster de conférence halshs-04290303 v1
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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-04290578 v1
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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-04290539 v1
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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-04290584 v1
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Bringing gene and cell therapies from lab to patients: the EuroGCT research pathways

Auxane Delage , Luc-Sylvain Gilbert , Hsin-Yu Kuo , Jennifer Lorigan , Clare Blackburn et al.
European Society for Gene & Cell Therapy Congress 2022, Oct 2022, Edinburgh, United Kingdom
Poster de conférence halshs-03901227 v1

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-03779362 v1