152 related articles for article (PubMed ID: 37737767)
1. A management model in blood, tissue and cell establishments to ensure rapid and sustainable patient access to advanced therapy medicinal products in Europe.
Delgadillo J; Kerkelä E; Waters A; Akker EVD; Lechanteur C; Baudoux E; Gardiner N; De Vos J; Vives J
Cytotherapy; 2023 Dec; 25(12):1259-1264. PubMed ID: 37737767
[TBL] [Abstract][Full Text] [Related]
2. Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products.
Cuende N; Ciccocioppo R; Forte M; Galipeau J; Ikonomou L; Levine BL; Srivastava A; Zettler PJ
Cytotherapy; 2022 Jul; 24(7):686-690. PubMed ID: 35545453
[TBL] [Abstract][Full Text] [Related]
3. Regulatory structures for gene therapy medicinal products in the European Union.
Klug B; Celis P; Carr M; Reinhardt J
Methods Enzymol; 2012; 507():337-54. PubMed ID: 22365782
[TBL] [Abstract][Full Text] [Related]
4. Business oriented EU human cell and tissue product legislation will adversely impact Member States' health care systems.
Pirnay JP; Vanderkelen A; De Vos D; Draye JP; Rose T; Ceulemans C; Ectors N; Huys I; Jennes S; Verbeken G
Cell Tissue Bank; 2013 Dec; 14(4):525-60. PubMed ID: 24052113
[TBL] [Abstract][Full Text] [Related]
5. The expanding role of blood and tissue establishments in the development of advanced therapy medicinal products.
Horan A; Warreth S; Hervig T; Waters A
Cytotherapy; 2024 May; 26(5):524-530. PubMed ID: 38441513
[TBL] [Abstract][Full Text] [Related]
6. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.
Iglesias-Lopez C; Obach M; Vallano A; Agustí A
Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
[TBL] [Abstract][Full Text] [Related]
7. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.
Salmikangas P; Schuessler-Lenz M; Ruiz S; Celis P; Reischl I; Menezes-Ferreira M; Flory E; Renner M; Ferry N
Adv Exp Med Biol; 2015; 871():103-30. PubMed ID: 26374215
[TBL] [Abstract][Full Text] [Related]
8. Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation.
de Wilde S; Veltrop-Duits L; Hoozemans-Strik M; Ras T; Blom-Veenman J; Guchelaar HJ; Zandvliet M; Meij P
Cytotherapy; 2016 Jun; 18(6):797-805. PubMed ID: 27068764
[TBL] [Abstract][Full Text] [Related]
9. Regulation of advanced therapy medicinal products in Europe and the role of academia.
Pearce KF; Hildebrandt M; Greinix H; Scheding S; Koehl U; Worel N; Apperley J; Edinger M; Hauser A; Mischak-Weissinger E; Dickinson AM; Lowdell MW
Cytotherapy; 2014 Mar; 16(3):289-97. PubMed ID: 24113428
[TBL] [Abstract][Full Text] [Related]
10. Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe.
Farkas AM; Mariz S; Stoyanova-Beninska V; Celis P; Vamvakas S; Larsson K; Sepodes B
Front Med (Lausanne); 2017; 4():53. PubMed ID: 28560211
[TBL] [Abstract][Full Text] [Related]
11. Advanced therapy medicinal products: Regulatory framework, hospital and pharmaceutical circuits in Europe and France.
Mebarki M; Madelaine I; Larghero J; de Jorna R
Therapie; 2022; 77(2):185-190. PubMed ID: 34895758
[TBL] [Abstract][Full Text] [Related]
12. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products in Europe.
Schuessler-Lenz M; Herberts C; Reischl I; Ruiz S; Celis P; Beuneu C; Kjeken R; Timón M
Adv Exp Med Biol; 2023; 1430():1-21. PubMed ID: 37526839
[TBL] [Abstract][Full Text] [Related]
13. Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union.
Beattie S;
Hum Gene Ther; 2021 Oct; 32(19-20):997-1003. PubMed ID: 33843251
[TBL] [Abstract][Full Text] [Related]
14. An assessment of the hospital exemption landscape across European Member States: regulatory frameworks, use and impact.
Hills A; Awigena-Cook J; Genenz K; Ostertag M; Butler S; Eggimann AV; Hubert A
Cytotherapy; 2020 Dec; 22(12):772-779.e1. PubMed ID: 33046395
[TBL] [Abstract][Full Text] [Related]
15. "Eurocode International Blood Labeling System" enables unique identification of all biological products from human origin in accordance with the European Directive 2004/23/EC.
Knels R; Mönig HJ; Wittmann G; von Versen R; Pruss A
Cell Tissue Bank; 2010 Nov; 11(4):345-52. PubMed ID: 20563859
[TBL] [Abstract][Full Text] [Related]
16. The Current State of Advanced Therapy Medicinal Products in the Czech Republic.
Kočí Z; Boráň T; Krůpa P; Kubinová Š
Hum Gene Ther Clin Dev; 2018 Sep; 29(3):132-147. PubMed ID: 29869533
[TBL] [Abstract][Full Text] [Related]
17. Comparison of new Brazilian legislation for the approval of advanced therapy medicinal products with existing systems in the USA, European Union and Japan.
Gomes KLG; da Silva RE; da Silva Junior JB; Novaes MRCG
Cytotherapy; 2022 May; 24(5):557-566. PubMed ID: 35227603
[TBL] [Abstract][Full Text] [Related]
18. Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries.
Coppens DGM; Hoekman J; De Bruin ML; Slaper-Cortenbach ICM; Leufkens HGM; Meij P; Gardarsdottir H
Cytotherapy; 2020 Oct; 22(10):592-600. PubMed ID: 32563611
[TBL] [Abstract][Full Text] [Related]
19. Encountering Challenges with the EU Regulation on Advance Therapy Medical Products.
Mansnérus J
Eur J Health Law; 2015 Dec; 22(5):426-61. PubMed ID: 26665690
[TBL] [Abstract][Full Text] [Related]
20. [European Blood Alliance (EBA) and EuroNet TMS: what challenges for the transfusion of tomorrow?].
Folléa G; de Wit J; Rouger P
Transfus Clin Biol; 2011 Apr; 18(2):106-14. PubMed ID: 21458349
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
