417 related articles for article (PubMed ID: 30815512)
1. EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation.
Detela G; Lodge A
Mol Ther Methods Clin Dev; 2019 Jun; 13():205-232. PubMed ID: 30815512
[TBL] [Abstract][Full Text] [Related]
2. Regulatory Aspects for Approval of Advanced Therapy Medicinal Products in the EU.
Fürst-Ladani S; Bührer A; Fürst W; Schober-Ladani N
Handb Exp Pharmacol; 2024; 284():367-387. PubMed ID: 37017789
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. 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]
5. 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]
6. Approval of First CAR-Ts: Have we Solved all Hurdles for ATMPs?
Seimetz D; Heller K; Richter J
Cell Med; 2019; 11():2155179018822781. PubMed ID: 32634192
[TBL] [Abstract][Full Text] [Related]
7. Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan.
Nagai S
Int J Mol Sci; 2019 Aug; 20(15):. PubMed ID: 31382625
[TBL] [Abstract][Full Text] [Related]
8. Market access pathways for cell therapies in France.
Rémuzat C; Toumi M; Jørgensen J; Kefalas P
J Mark Access Health Policy; 2015; 3():. PubMed ID: 27123176
[TBL] [Abstract][Full Text] [Related]
9. Advancing rare disease treatment: EMA's decade-long insights into engineered adoptive cell therapy for rare cancers and orphan designation.
Kalland ME; Pose-Boirazian T; Palomo GM; Naumann-Winter F; Costa E; Matusevicius D; Duarte DM; Malikova E; Vitezic D; Larsson K; Magrelli A; Stoyanova-Beninska V; Mariz S
Gene Ther; 2024 Mar; ():. PubMed ID: 38480914
[TBL] [Abstract][Full Text] [Related]
10. Marketing authorisations for unmet medical needs: A critical appraisal of regulatory pathways in the European Union.
Manellari S; Musazzi UM; Rocco P; Minghetti P
Int J Pharm; 2023 Jul; 642():123193. PubMed ID: 37394157
[TBL] [Abstract][Full Text] [Related]
11. Technology forecast: advanced therapies in late clinical research, EMA approval or clinical application via hospital exemption.
Eder C; Wild C
J Mark Access Health Policy; 2019; 7(1):1600939. PubMed ID: 31069029
[No Abstract] [Full Text] [Related]
12. 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]
13. The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018.
Schuster Bruce C; Brhlikova P; Heath J; McGettigan P
PLoS Med; 2019 Sep; 16(9):e1002873. PubMed ID: 31504034
[TBL] [Abstract][Full Text] [Related]
14. Environmental risk assessment of advanced therapies containing genetically modified organisms in the EU.
Whomsley R; Palmi Reig V; Hidalgo-Simon A
Br J Clin Pharmacol; 2021 Jun; 87(6):2450-2458. PubMed ID: 33600022
[TBL] [Abstract][Full Text] [Related]
15. Post-marketing authorisation safety and efficacy surveillance of advanced therapy medicinal products in Brazil, the European Union, the United States and Japan.
Gomes KLG; da Silva RE; da Silva JB; Bosio CGP; Novaes MRCG
Cytotherapy; 2023 Oct; 25(10):1113-1123. PubMed ID: 37436339
[TBL] [Abstract][Full Text] [Related]
16. Advanced Therapy Medicinal Products Challenges and Perspectives in Regenerative Medicine.
Goula A; Gkioka V; Michalopoulos E; Katsimpoulas M; Noutsias M; Sarri EF; Stavropoulos C; Kostakis A
J Clin Med Res; 2020 Dec; 12(12):780-786. PubMed ID: 33447311
[TBL] [Abstract][Full Text] [Related]
17. 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. PubMed ID: 21698533
[TBL] [Abstract][Full Text] [Related]
18. 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]
19. 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]
20.
; ; . PubMed ID:
[No Abstract] [Full Text] [Related]
[Next] [New Search]