Results 111 to 120 of about 1,892 (131)

Managing costly new drugs to support equitable access: international collaboration and patient engagement to assess value, and managed entry agreements.

BMJ
Sharma T, Kruja K, Årdal C, Lopert R, Mestre-Ferrandiz J, Boselli S, Vogler S.   +6 more
europepmc   +1 more source

RESTORE Survey on the Public Perception of Advanced Therapies and ATMPs in Europe—Why the European Union Should Invest More!

Frontiers in Medicine, 2021
Advanced therapy medicinal products (ATMPs) are potential game changers in modern medical care with an anticipated major impact for patients and society.
Guido Moll, Hans-Dieter Volk, Petra Reinke   +2 more
exaly   +3 more sources

ARM’s Perspective on the First Joint Clinical Assessments for ATMPs: Challenges and Opportunities on the Path Ahead

Journal of Market Access & Health Policy
Advanced Therapy Medicinal Products (ATMPs) are revolutionising modern medicine. By addressing the root cause rather than the symptoms of disease, ATMPs hold the promise of long-lasting benefits or even cures for severe, genetic, and rare diseases ...
Paolo Morgese, Stephen Majors, Dilip Patel   +2 more
exaly   +3 more sources

EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation

Molecular Therapy - Methods and Clinical Development, 2019
Advanced therapy medicinal products (ATMPs) require evaluation by the European Medicines Agency’s Committee for Advanced Therapies prior to being placed on the European market, subject to a Marketing Authorisation granted by the European Commission.
Giulia Detela, Anthony Lodge
exaly   +3 more sources

The role of hospital pharmacists in supporting the appropriate and safe use of CGT/ATMPs: a scoping review of current insights

BMC Health Services Research
Background The role of hospital pharmacists in managing cell and gene therapy (CGT) and advanced therapy medicinal products (ATMPs) is gradually being recognized but the evidence about impact of their role has not been systematically reported.
Carolina Oi Lam Ung, Junnan Shi, Xianwen Chen   +2 more
exaly   +2 more sources

Current challenges and future directions of ATMPs in regenerative medicine

Regenerative Therapy
Advanced therapy medicinal products (ATMPs) represent a groundbreaking category of medications that utilize biological-based products to treat or replace damaged organs.
Massoud Vosough, Mohammad Rahmanian
exaly   +3 more sources

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Viability of European cross-border access opportunities to streamline access to ATMPs

Health Policy and Technology, 2023
Luigi Angelillo, Cécile van Steen
exaly  

Analysis of GMP for Marketing Authorization of ATMPs: Comparison in the US, the EU, Japan and South Korea

Regenerative Medicine, 2022
Eunyoung Kim, Hocheol Shin
exaly  

Advanced Therapy Medicinal Products (ATMPs)

Drug Development and Pharmaceutical Science, 2022
James Phillips
exaly  

A comprehensive report of long-term stability data for a range ATMPs: A need to develop guidelines for safe and harmonized stability studies

Cytotherapy, 2022
Patrizia Comoli, Martino Introna, Simona Frigerio   +2 more
exaly