Results 111 to 120 of about 7,093,593 (187)

PBI29 ADVANCED THERAPY MEDICINAL PRODUCTS (ATMP): EUROPEAN REGULATORY FRAMEWORK COMPARED TO GERMANY [PDF]

Value in Health, 2019
E. Mueller, K. Neeser, I.B. Oelze
openaire   +1 more source

Legal pathways to optimize access to Advanced Therapy Medicinal Products (ATMP)

Advanced therapy medicinal products (ATMP), although offering considerable medical advances, are not accessible to patients because of their high prices. Managed entry agreements (MEA), particularly performance-based agreements (PbA), are an interesting way of facilitating access to these treatments while controlling the financial risk involved in ...
openaire   +1 more source

Advanced therapy medicinal products in Saudi Arabia: Regulation and development. [PDF]

Regen Ther
AlMuhanna MH, Alharbi M, Aldahash A, Felemban R, Asiri L, Alghamdi M, Alzahrani R, Aldossary W, Alenzi N, Almohaywi M.   +9 more
europepmc   +1 more source

Advanced Therapy Medicinal Products (ATMPs) in the light of precision (personalized) medicine

Journal of Biotechnology & Biomaterials, 2018
openaire   +1 more source

Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets. [PDF]

BioTech (Basel)
Verma N, Arora S.
europepmc   +1 more source

Expanding Patient Access to Advanced Therapies. [PDF]

BioDrugs
Guillen E, Hidalgo-Simon A.
europepmc   +1 more source

Engineering the future of advanced therapy medicinal products: a bioengineering call to action. [PDF]

Front Bioeng Biotechnol
Nieri G, Spiller A, Federico S, Aiuti A, Piemonti L.   +4 more
europepmc   +1 more source

The in vivo revolution in CAR-T therapy medicinal products: challenges and regulatory prospects. [PDF]

Signal Transduct Target Ther
Lu J, Cui J, Dong J, Yan L, Wang X, Zhou D, Lu S, Wei W.   +7 more
europepmc   +1 more source

Regulatory approach to manipulated organs in Europe: preserving human organs as non-commercial goods. [PDF]

Transpl Int
Cuende N, Izeta A, Domínguez-Gil B.
europepmc   +1 more source

PBI35 HEALTH ECONOMICS MODELLING FOR ADVANCED THERAPY MEDICINAL PRODUCTS (ATMP): A TARGETED LITERATURE REVIEW (LR) [PDF]

Value in Health, 2019
I. Agirrezabal, L. Beswick, D.J. Fielden, A. Howell   +3 more
openaire   +1 more source