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Items: 1 to 20 of 165

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.

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. doi: 10.1016/j.jcyt.2016.02.010. Epub 2016 Apr 5.

PMID:
27068764
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. doi: 10.1007/978-3-319-18618-4_6. Review.

PMID:
26374215
4.

Encountering Challenges with the EU Regulation on Advance Therapy Medical Products.

Mansnérus J.

Eur J Health Law. 2015 Dec;22(5):426-61.

PMID:
26665690
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):69-94. doi: 10.2515/therapie/2015005. Epub 2015 Mar 6. English, French.

PMID:
25747840
6.

[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.

7.

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
8.

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.

9.

Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

Renner M, Anliker B, Sanzenbacher R, Schuele S.

Adv Exp Med Biol. 2015;871:87-101. doi: 10.1007/978-3-319-18618-4_5. Review.

PMID:
26374214
10.

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
11.

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. Review.

PMID:
20190786
12.

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 May 16;4:53. doi: 10.3389/fmed.2017.00053. eCollection 2017.

13.

[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
14.

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
15.

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. doi: 10.1089/humc.2016.193. Epub 2017 May 16. Review.

PMID:
28510497
16.

Advanced therapy medicinal products: current and future perspectives.

Hanna E, Rémuzat C, Auquier P, Toumi M.

J Mark Access Health Policy. 2016 Apr 25;4. doi: 10.3402/jmahp.v4.31036. eCollection 2016.

17.

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.

18.
19.

About ATMPs, SOPs and GMP: The Hurdles to Produce Novel Skin Grafts for Clinical Use.

Hartmann-Fritsch F, Marino D, Reichmann E.

Transfus Med Hemother. 2016 Sep;43(5):344-352. Epub 2016 Sep 6. Review.

20.

[Regulatory framework of innovative therapies : From bench to bedside].

Walter C, Rohde B, Wicke DC, Pohler C, Lührmann A, von der Leyen H.

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Jul;54(7):803-10. doi: 10.1007/s00103-011-1308-z. Review. German.

PMID:
21698532

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