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Similar articles for PubMed (Select 24113428)

1.

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. doi: 10.1016/j.jcyt.2013.08.003. Epub 2013 Oct 8. Review.

PMID:
24113428
2.

European regulatory tools for advanced therapy medicinal products.

Flory E, Reinhardt J.

Transfus Med Hemother. 2013 Dec;40(6):409-12. doi: 10.1159/000356364. Epub 2013 Oct 28. Review.

3.

[Academic cell therapy facilities are challenged by European regulation on advanced therapy medicinal products].

Chabannon C, Sabatier F, Rial-Sebbag E, Calmels B, Veran J, Magalon G, Lemarie C, Mahalatchimy A.

Med Sci (Paris). 2014 May;30(5):576-83. doi: 10.1051/medsci/20143005022. Epub 2014 Jun 13. French.

PMID:
24939546
4.

Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: a novel tailored model for optimizing performance and estimating costs.

Abou-El-Enein M, Römhild A, Kaiser D, Beier C, Bauer G, Volk HD, Reinke P.

Cytotherapy. 2013 Mar;15(3):362-83. doi: 10.1016/j.jcyt.2012.09.006.

PMID:
23579061
5.

Creating conditions for the success of the French industrial advanced therapy sector.

Lirsac PN, Blin O, Magalon J; participants of round table N°5 of Giens XXX:, Angot P, de Barbeyrac E, Bilbault P, Bourg E, Damour O, Faure P, Ferry N, Garbil B, Larghero J, Nguon M, Pattou F, Thumelin S, Yates F.

Therapie. 2015 Jan-Feb;70(1):83-94. doi: 10.2515/therapie/2015005. Epub 2015 Mar 6.

PMID:
25747840
6.

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. doi: 10.1016/B978-0-12-386509-0.00017-X.

PMID:
22365782
7.

A comprehensive resource on EU regulatory information for investigators in gene therapy clinical research and advanced therapy medicinal products.

Cohen-Haguenauer O.

Hum Gene Ther. 2013 Jan;24(1):12-8. doi: 10.1089/hum.2012.2525. Review. No abstract available.

PMID:
23339285
8.

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. doi: 10.1007/s10561-013-9397-6. Epub 2013 Sep 20.

9.

Challenges with advanced therapy medicinal products and how to meet them.

Committee for Advanced Therapies (CAT); CAT Scientific Secretariat, Schneider CK, Salmikangas P, Jilma B, Flamion B, Todorova LR, Paphitou A, Haunerova I, Maimets T, Trouvin JH, Flory E, Tsiftsoglou A, Sarkadi B, Gudmundsson K, O'Donovan M, Migliaccio G, Ancāns J, Maciulaitis R, Robert JL, Samuel A, Ovelgönne JH, Hystad M, Fal AM, Lima BS, Moraru AS, Turcáni P, Zorec R, Ruiz S, Akerblom L, Narayanan G, Kent A, Bignami F, Dickson JG, Niederwieser D, Figuerola-Santos MA, Reischl IG, Beuneu C, Georgiev R, Vassiliou M, Pychova A, Clausen M, Methuen T, Lucas S, Schüssler-Lenz M, Kokkas V, Buzás Z, MacAleenan N, Galli MC, Linē A, Gulbinovic J, Berchem G, Fraczek M, Menezes-Ferreira M, Vilceanu N, Hrubisko M, Marinko P, Timón M, Cheng W, Crosbie GA, Meade N, di Paola ML, VandenDriessche T, Ljungman P, D'Apote L, Oliver-Diaz O, Büttel I, Celis P.

Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052.

PMID:
20190786
10.

Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis.

Van Wilder P.

Front Pharmacol. 2012 Feb 14;3:12. doi: 10.3389/fphar.2012.00012. eCollection 2012.

11.
12.

[Report from the Committee for Advanced Therapies (CAT). Pitfalls on the way from concept to medical treatment with advanced therapy medicinal products].

Reiss M, Büttel IC, Schneider CK.

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Jul;54(7):822-30. doi: 10.1007/s00103-011-1304-3. Review. German.

PMID:
21698535
13.

Translational research on advanced therapies.

Belardelli F, Rizza P, Moretti F, Carella C, Galli MC, Migliaccio G.

Ann Ist Super Sanita. 2011;47(1):72-8. doi: 10.4415/ANN_11_01_15. Review.

14.
15.
16.

The advanced therapy classification procedure. Overview of experience gained so far.

Voltz-Girolt C, Celis P, Boucaumont M, D'Apote L, Pinheiro MH, Papaluca-Amati M.

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Jul;54(7):811-5. doi: 10.1007/s00103-011-1309-y. Review.

PMID:
21698533
17.

The role of the Istituto Superiore di Sanità as the competent authority for Phase I trials in the translation of advanced therapies.

Popoli P, Cometa MF, Fabi F, Meneguz A.

Ann Ist Super Sanita. 2011;47(1):79-82. doi: 10.4415/ANN_11_01_16. Review.

18.

Gene and cell therapy for children--new medicines, new challenges?

Buckland KF, Bobby Gaspar H.

Adv Drug Deliv Rev. 2014 Jun;73:162-9. doi: 10.1016/j.addr.2014.02.010. Epub 2014 Feb 28. Review.

19.

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

Kroes BH.

J Ethnopharmacol. 2014 Dec 2;158 Pt B:449-53. doi: 10.1016/j.jep.2014.07.044. Epub 2014 Jul 31.

PMID:
25086408
20.

Role of the blood service in cellular therapy.

Rebulla P, Giordano R.

Biologicals. 2012 May;40(3):218-21. doi: 10.1016/j.biologicals.2011.10.007. Epub 2011 Nov 6.

PMID:
22063066
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