Document Detail


Participation of patients in the development of advanced therapy medicinal products.
MedLine Citation:
PMID:  21698537     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
An increasing number of advanced therapy medicinal products (ATMPs) are under development and in clinical trials. Patients are central to this progress. In research, patients have funded, catalysed, coordinated and led projects. In regulation, patient groups have contributed to the creation of the political momentum for regulation of ATMPs, contributed to the debate and now participate in the regulatory process. Once licensed, patients will have a role in the pharmacovigilance, health technology assessment and reimbursement arrangements for these products. Patient groups contribute valuably as equal stakeholders at every step of the development of an ATMP.
Authors:
F Bignami; A J Kent; M Lipucci di Paola; N Meade
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Publication Detail:
Type:  JOURNAL ARTICLE    
Journal Detail:
Title:  Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz     Volume:  54     ISSN:  1437-1588     ISO Abbreviation:  -     Publication Date:  2011 Jul 
Date Detail:
Created Date:  2011-6-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101181368     Medline TA:  Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz     Country:  -    
Other Details:
Languages:  ENG     Pagination:  839-842     Citation Subset:  -    
Affiliation:
EURORDIS (European Organisation for Rare Diseases), Paris, Frankreich.
Vernacular Title:
Teilnahme von Patienten an der Entwicklung von Arzneimitteln für neuartige Therapien.
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