Aurélie Mahalatchimy et Luc-Sylvain Gilbert, Accelerated Assessment of ATMPs, p. NC
Aurélie Mahalatchimy, Anaëlle Scheer, Valentin BRUNEL, Simon Guion, Indra Chiv, Manon Morell, Marilou Durand, Olivio Jaonina et Véronique Andrieu, An exploratory analysis on the involvement of European organisations in the field of biomedical innovation, p. NC, Belgium
Aurélie Mahalatchimy, Auxane Delage, Luc-Sylvain Gilbert, Hsin-Yu Kuo, Jennifer Lorigan, Clare Blackburn, Anna Couturier et Amanda Waite, Bringing gene and cell therapies from lab to patients: the EuroGCT research pathways, p. NC, United Kingdom of Great Britain and Northern Ireland
Aurélie Mahalatchimy, Commercialisation: Advertising of ATMPs, p. NC
Aurélie Mahalatchimy, Éloïse Gennet, Véronique Andrieu, Marion Feraud, Victoire Lacaille, Julie Veran, Florence Sabatier et Michael Morrison, Comparative quality aspects of gene therapy medicinal products and medicinal products containing genetically modified cells, p. NC, Belgium
Aurélie Mahalatchimy et Valentin BRUNEL, Comparing actors participating in the adoption process of SoHo and ATMP regulations at the European level, p. NC, Belgium
Aurélie Mahalatchimy et Luc-Sylvain Gilbert, Conditional Marketing Authorisation of ATMPs, p. NC
Aurélie Mahalatchimy et Alex Faulkner, Conflicting values of biomedical innovation?, p. NC
Aurélie Mahalatchimy, Claire Cherrier, Andréa Chiasserini, Marianne Paolantonacci, Guylène Nicolas et Véronique Andrieu, Des dispositifs médicaux au service du transhumanisme: jusqu’où doit-on aller ?, p. NC
Aurélie Mahalatchimy et Auxane Delage, Early interactions with regulators, p. NC
Aurélie Mahalatchimy et Auxane Delage, Early interactions with regulators- Support for innovative medicines’ development, p. NC
Aurélie Mahalatchimy et Auxane Delage, Early interactions with regulators: Support for innovative medicines’ development at the EMA level, p. NC
Aurélie Mahalatchimy et Auxane Delage, Early interactions with regulators: Support specific to ATMPs’ development at EMA level, p. NC
Aurélie Mahalatchimy, Hsin-Yu Kuo, Luc-Sylvain Gilbert, Auxane Delage et Clare Blackburn, 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 et 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
Aurélie Mahalatchimy, Edouard Habib, Luc-Sylvain Gilbert et Amanda Waite, EuroGCT Deliverable D4. 8: Initial landscape mapping, pp. 1-86
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Edouard Habib et Amanda Waite, EuroGCT Deliverable D4.4: Regulator Engagement Strategy, pp. 1-59
Aurélie Mahalatchimy, Edouard Habib, Luc-Sylvain Gilbert, Hsin-Yu Kuo, Éloïse Gennet et Amanda Waite, EuroGCT Deliverable D4.7: Information collation, pp. 1-87
Aurélie Mahalatchimy, Hsin-Yu Kuo, Luc-Sylvain Gilbert, Auxane Delage et Anna Couturier, EuroGCT Deliverable D4.7: Information collation, report on collation of existing information and links on where to seek information and guidance- Version 2.0
Aurélie Mahalatchimy, Hsin-Yu Kuo et Amanda Waite, EuroGCT Deliverable D4.9: Initial information on practical steps, p. NC
Aurélie Mahalatchimy, Auxane Delage, Luc-Sylvain Gilbert, Hsin-Yu Kuo, Anna Couturier, Jennifer Lorigan et 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
Aurélie Mahalatchimy, Auxane Delage, Luc-Sylvain Gilbert, Hsin-Yu Kuo, Jennifer Lorigan, Clare Blackburn et Anna Couturier, Finding out the regulatory requirements for the development of Gene and Cell therapy products with the EuroGCT research pathways, p. NC
Aurélie Mahalatchimy, Genome editing and the European Union, Genome editing and the law around the world, p. NC
Aurélie Mahalatchimy, Éloïse Gennet, Markus Frischhut, 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, Elena Petelos, Marko Ocokoljic, Charlotte Godziewski, Olivier Negre, Piotr Kolczynski, François Houÿez, Hrishikesh Kulkarni, Marcin Rodzinka- Verhelle et Tadeusz Hawrot, Health as a fundamental value. Towards an inclusive and equitable pharmaceutical strategy for the European Union, p. NC
Aurélie Mahalatchimy, Éloïse Gennet, Mbathie Mbengue, Perron Martine, Valentin Brunel, Léa Mosnier et Caroline Sophie Donati, I-BioLex Deliverable D9-1-2.0: Data Management Plan, p. NC
Aurélie Mahalatchimy, Eloïse Gennet, Mbathie Mbengue, Perron Martine, Caroline Sophie Donati, Valentin BRUNEL et Léa Mosnier, I-BioLex Deliverable D9-1: Data Management Plan version 2.0
Aurélie Mahalatchimy, Éloïse Gennet, Mbathie Mbengue, Mbathie Mbengue, Perron Martine et Caroline Sophie Donati, I-BioLex Deliverable D9-1: Data Management Plan, Version 1.0, pp. 1-20/DOI : 105281/zenodo7085166
Aurélie Mahalatchimy, Florence Lanson, Blanka Bartos et Florence Taboulet, Improving access to innovative medicines: proposals from national authorities to revise the European legislation, p. NC, United Kingdom of Great Britain and Northern Ireland
Aurélie Mahalatchimy, Thomas Allouche, Frédéric Bechet, Valentin BRUNEL et Marie Glinel, Innovative therapy in European Parliament's positions: a numerical science-based vocabulary analysis, p. NC, Belgium
Aurélie Mahalatchimy, L'impact du droit de l'Union européenne sur la règlementation des médicaments de thérapie innovante en France et au Royaume-Uni
Aurélie Mahalatchimy, Martine Perron et Guylène Nicolas, La recherche sur « Transhumanisme : de nouveaux droits ? », p. NC
Aurélie Mahalatchimy, Marine Lahaye, Victoria Perkins, Christophe Charleux, Guylène Nicolas et Véronique Andrieu, Le sport augmenté, une révolution en marche à autoriser ?, p. NC
Aurélie Mahalatchimy et Florence Taboulet, Manufacturing and batch testing of medicines, The Oxford Encylopedia of EU Law, p. NC
Aurélie Mahalatchimy, Auxane Delage, Luc-Sylvain Gilbert, Hsin-Yu Kuo et Anna Couturier, Mapping regulators’ early interactions procedures to support innovation, p. NC, Belgium
Aurélie Mahalatchimy, Valentin Roby, Anaëlle Scheer, Julien Veran et Florence Sabatier, Mapping the ATMPs Guidance Landscape, p. NC, Belgium
Aurélie Mahalatchimy et Luc-Sylvain Gilbert, Market Access for ATMPs- Expediting marketing authorisation pathways, p. NC
Aurélie Mahalatchimy et Luc-Sylvain Gilbert, Market Access for ATMPs- Specificities of the marketing authorisation dossier for biosimilars, p. NC
Aurélie Mahalatchimy et Luc-Sylvain Gilbert, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure, p. NC
Aurélie Mahalatchimy et Luc-Sylvain Gilbert, Market Access for ATMPs- Standard Marketing Authorisation Pathway: Centralised Procedure/ Marketing Authorisation Application file, p. NC
Aurélie Mahalatchimy et Luc-Sylvain Gilbert, Marketing Authorisation under exceptional circumstances for ATMPs, p. NC
Aurélie Mahalatchimy, Martine Perron et Guylène Nicolas, OBSERVATIONS SUR LA COMMUNICATION, LES RELATIONS INTERPERSONNELLES ET LES INTERACTIONS DANS LES CLASSES AUTOUR DE LA THEMATIQUE « TRANSHUMANISME ET DROIT », p. NC
Aurélie Mahalatchimy et Éloïse Gennet, Orphan medicines, in Oxford University Press (dir.), Oxford Encyclopedia of EU Law
Aurélie Mahalatchimy et Luc-Sylvain Gilbert, Packaging and labelling of ATMPs, p. NC
Aurélie Mahalatchimy et Jean-Christophe Galloux, Post/Trans-humanisme et droits de l’Homme - Dimension économique, Documents de réflexion: transhumansimes et droits de l’homme, p. NC
Aurélie Mahalatchimy, Julie Veran, Florence Sabatier, Michael Morrison, Carla Le Corre, Carlota Santos- Peixoto, Éloïse Gennet et Véronique Andrieu, Production Aspects of Advanced Therapy Medicinal Products, p. NC, Belgium
Aurélie Mahalatchimy, Julie Veran, Michael Morrison, Florence Sabatier, Léa Chey, Fatou Mbodj, Éloïse Gennet et Véronique Andrieu, Quality control and batch release aspects of Advanced Therapy Medicinal Products, p. NC, Belgium
Aurélie Mahalatchimy, Justine Veret, Jihane Arbouhi, Marie-Charlotte C Bernard, Véronique Andrieu et Guylène Nicolas, Quels bébés pour demain?, p. NC
Aurélie Mahalatchimy et Emmanuelle Rial-Sebbag, Regulation of stem cell research in France, p. NC
Aurélie Mahalatchimy, Regulation of stem cell research in the United Kingdom, p. NC
Aurélie Mahalatchimy, Luc-Sylvain Gilbert, Auxane Delage, Hsin-Yu Kuo et Anna Couturier, The challenges of Advanced Therapy Medicinal Products manufacturing in the European Union: Strengths and limits of current regulatory tools, p. NC, Belgium
Aurélie Mahalatchimy et Éloïse Gennet, The current revision of the orphan medicines regulation in the EU: what is at stake for gene and cell therapy?, p. NC, United Kingdom of Great Britain and Northern Ireland
Aurélie Mahalatchimy, John Gardner, Alex Faulkner, Andrew Webster, Claude Lemarié-Basset, Boris Calmels, Bechara Mfarrej et Christian Chabannon, The delivery of advanced therapies to patients: challenges and solutions, p. NC
Aurélie Mahalatchimy, Blanka Bartos, Joséphine Juët et Florence Taboulet, The new European regulation on Health Technology Assessment: what changes for Advanced Therapy Medicinal Products ?, p. NC, United Kingdom of Great Britain and Northern Ireland
Aurélie Mahalatchimy, Therapy classification: Human body elements for therapeutic applications, p. NC
Aurélie Mahalatchimy, Claire Misi, Marine Migliore, Antoine Chevallier, Guylène Nicolas et Véronique Andrieu, Thérapie génique germinale et transhumanisme: entre amélioration de la qualité de vie et eugénisme, p. NC
Aurélie Mahalatchimy et Florence Taboulet, Transparency of medicines pricing, The Oxford Encylopedia of EU Law [OEEUL], p. NC
Aurélie Mahalatchimy, Véronique Andrieu, Éloïse Gennet, Julie Veran, Michael Morrison et Florence Sabatier, What are the quality challenges regarding comparibility considerations of Advanced Therapy Medicinal Products?, p. NC, Belgium
Aurélie Mahalatchimy, Éloïse Gennet, Florence Sabatier, Julie Veran, Diack Adja Fatou, Nada Mongalgi, Véronique Andrieu et Michael Morrison, What specificity for the clinical aspects of investigational advanced therapy medicinal products?, p. NC, Belgium
Aurélie Mahalatchimy, Éloïse Gennet, Martine Perron, Marc Bernardot, Christophe Salvat et Guylène Nicolas, ÉVALUATION À MI-PARCOURS DU PROJET DE RECHERCHE RELATIF AU TRANSHUMANISME, p. NC