495 related articles for article (PubMed ID: 28510497)
1. Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?
Boráň T; Menezes-Ferreira M; Reischl I; Celis P; Ferry N; Gänsbacher B; Krafft H; Lipucci di Paola M; Sladowski D; Salmikangas P
Hum Gene Ther Clin Dev; 2017 Sep; 28(3):126-135. PubMed ID: 28510497
[TBL] [Abstract][Full Text] [Related]
2. 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]
3. 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]
4. 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]
5. 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]
6. 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]
7. 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]
8. 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]
9. 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]
10. Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe.
Ten Ham RMT; Hoekman J; Hövels AM; Broekmans AW; Leufkens HGM; Klungel OH
Mol Ther Methods Clin Dev; 2018 Dec; 11():121-130. PubMed ID: 30456217
[TBL] [Abstract][Full Text] [Related]
11. [European Marketing Authorisation: a long process. Experiences of small biotech companies with the ATMP regulation].
Buljovčić Z
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2011 Jul; 54(7):831-8. PubMed ID: 21698536
[TBL] [Abstract][Full Text] [Related]
12. 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]
13. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].
Pflieger M; Bertram D
Arch Pediatr; 2014 Oct; 21(10):1129-38. PubMed ID: 25175054
[TBL] [Abstract][Full Text] [Related]
14. European regulatory tools for advanced therapy medicinal products.
Flory E; Reinhardt J
Transfus Med Hemother; 2013 Dec; 40(6):409-12. PubMed ID: 24474890
[TBL] [Abstract][Full Text] [Related]
15. 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]
16. [Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products].
Jost N; Schüssler-Lenz M; Ziegele B; Reinhardt J
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2015 Nov; 58(11-12):1207-14. PubMed ID: 26369763
[TBL] [Abstract][Full Text] [Related]
17. Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development.
Ancans J
Front Immunol; 2012; 3():253. PubMed ID: 22912639
[TBL] [Abstract][Full Text] [Related]
18. A harmonized and efficient clinical research environment would benefit patients and enhance European competitiveness. Commentary.
Amato A; Aringhieri E; Boccia S; Buccella F; Gorini B; Gramaglia D; Masetti R; Rossi P; Pelicci PG
Ann Ist Super Sanita; 2017; 53(2):104-107. PubMed ID: 28617255
[TBL] [Abstract][Full Text] [Related]
19. 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]
20. 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]
[Next] [New Search]