Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive
about
Cell-based therapy technology classifications and translational challengesWhither advanced therapy medicinal products?White paper on how to go forward with cell-based advanced therapies in Europe.Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.Innovative regenerative medicines in the EU: a better future in evidence?Advanced therapy medicinal products: current and future perspectivesPerspective: communications with the Food and Drug Administration on the development pathway for a cell-based therapy: why, what, when, and how?From lipoproteins to chondrocytes: a brief summary of the European Medicines Agency's regulatory guidelines for advanced therapy medicinal products.Regulation of cell-based therapies in Europe: current challenges and emerging issuesClinical development of gene- and cell-based therapies: overview of the European landscapeCurrent status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies.Regulatory authorities and orthopaedic clinical trials on expanded mesenchymal stem cells.Reflections on how wound healing-promoting effects of the hair follicle can be translated into clinical practice.Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.Virus-specific T-cell therapy in solid organ transplantation.Landscape of current and emerging cell therapy clinical trials in the UK: current status, comparison to global trends and future perspectives.CASMI TSCC launch event, Paris, France, July 2013: an assessment of the key barriers to the commercialization and clinical adoption of pluripotent stem cell therapies.Regulatory evaluation of Glybera in Europe - two committees, one mission.Trends in the stem cell and regenerative medicine industry.The Evolution of Nonclinical Regulatory Science: Advanced Therapy Medicinal Products as a Paradigm.Quality compliance in the development of cell-based medicines in non-pharma environments.The limited application of stem cells in medicine: a review.A decade of cell therapy clinical trials (2000-2010).Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation.The evolution of nonclinical regulatory science: advanced therapy medicinal products as a paradigm.Cell and Gene Therapies: European View on Challenges in Translation and How to Address Them.Gatekeepers and Enablers: How Drug Regulators Respond to a Challenging and Changing Environment by Moving Toward a Proactive AttitudeChallenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe
P2860
Q26785346-779811E8-243C-4B5A-B0E5-8CFF93EA26BDQ28660122-A73E3A2E-77DB-42FA-8199-16BD973A1041Q34331082-00991103-6AD7-4796-B860-EB4893C218BAQ35789528-348D706D-7B29-49CC-A923-89872F550258Q36300179-4583EAAC-FA46-432E-9ACF-72AB0946C94FQ36840842-F76C6297-8607-47EB-B7D9-30973F459BDFQ36861434-601F2A58-4547-407E-B3E0-905AF2839EB2Q36945703-67E9E190-EB5B-43E5-9573-6750DF45DB30Q37442918-BFD29E76-0F37-468B-891E-DB7D6F62A156Q37458114-C1903A8A-06F6-4DEC-A8BF-C049BE81C186Q38160633-D59C899A-0BC7-429D-86CD-C3FE2E6249AEQ38204261-34871502-AE78-4502-84FC-03466CBFFA69Q38234412-35227054-1282-4714-9936-BEC0CBC06F40Q38308667-6D42D895-D39C-483F-8105-FC71BFE19498Q38568902-467B4910-B3E7-4859-B8BE-4DD2A6F5E8E4Q39022356-58A38CAF-EA6C-4E1A-AE17-F4BB4285D10FQ42464275-8AA7E80F-9238-43AF-9767-7E9C2541D824Q44335184-4B85A55A-1064-4CA6-A64A-A1735D58AD00Q44479202-365F5E2A-B525-4069-9E8E-BB57251A664DQ46067982-E42C992E-FD5F-425C-B2D6-BCC0E75CD5E8Q46251655-44EA4599-9CC2-4887-8AA8-D37D2334F132Q47134432-E57173D9-275C-4D2C-93BC-5083FC3F0775Q48413558-495D3C31-20F5-4D88-A16C-456C6AE0E257Q49566187-562E5498-A606-4DB1-A626-EAAE6FDC4DD9Q54733428-B7A4239D-41F9-4BAF-9718-EF756287BFD6Q55222732-E95B1983-4E90-439F-8363-A8317C7A3602Q57305772-DA473827-90CF-4647-B139-CE37DE719FF0Q59129650-24F795F6-DA17-4DBB-84E2-07CA43D429B8
P2860
Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive
description
2012 nî lūn-bûn
@nan
2012年の論文
@ja
2012年論文
@yue
2012年論文
@zh-hant
2012年論文
@zh-hk
2012年論文
@zh-mo
2012年論文
@zh-tw
2012年论文
@wuu
2012年论文
@zh
2012年论文
@zh-cn
name
Clinical development of advanc ...... t regulators must be proactive
@ast
Clinical development of advanc ...... t regulators must be proactive
@en
type
label
Clinical development of advanc ...... t regulators must be proactive
@ast
Clinical development of advanc ...... t regulators must be proactive
@en
prefLabel
Clinical development of advanc ...... t regulators must be proactive
@ast
Clinical development of advanc ...... t regulators must be proactive
@en
P2093
P2860
P356
P1433
P1476
Clinical development of advanc ...... t regulators must be proactive
@en
P2093
Andrew Buchanan
Christian K Schneider
Laura Pioppo
Lucia D'Apote
Romaldas Maciulaitis
P2860
P304
P356
10.1038/MT.2012.13
P577
2012-03-01T00:00:00Z