Participation of patients in the development of advanced therapy medicinal products
Bignami, F.; Kent, A.; Lipucci di Paola, M.; Meade, N. · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · 2011 · Heft 6 · S. 839 bis 842
Bibliografische Angaben
Zusammenfassung
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…