Results 71 to 80 of about 1,892 (131)

Developing and validating a regulatory science competency framework for immune cell therapy: a mixed-methods study. [PDF]

Front Med (Lausanne)
Lee JA.
europepmc   +1 more source

Why promising ATMPs fail to reach patients: a qualitative stakeholder-informed analysis of cell therapy access in Europe. [PDF]

J Transl Med
Di Mauro G, Pachetti M, Ploner C, De Luca M, Pellegrini G, Gambini E, Moretti M, Sfiligoj A, Yordanov TE, Knezevic M, Sidoti GB, Papa G, Zacchigna S.   +12 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

Advanced therapy medicinal product (ATMP) classification - a case study on spinal cord injury. [PDF]

J Transl Med
Duarte L, Castellà M, Marques PAAP, Gago B.   +3 more
europepmc   +1 more source

Developing a consensus-based competency framework for hospital pharmacists in the management of advanced therapy medicinal products (ATMPs): a modified delphi study in Macao. [PDF]

BMC Med Educ
Shi J, Hu H, Ung COL.
europepmc   +1 more source

When will bioprinting become a therapy? Translational and regulatory challenges in urogenital tissue engineering and surgery. [PDF]

Front Bioeng Biotechnol
Ruding M, Shajahan AB, Fossum M, Pennisi CP, Lind JU.   +4 more
europepmc   +1 more source

Addressing clinical uncertainties in ATMP reimbursement: a review of methodological guidelines and European practice. [PDF]

Front Pharmacol
Delemarre L, Huys I, Van Dyck W, Simoens S.   +3 more
europepmc   +1 more source

Regulatory Challenges and Opportunities for Cell-Derived Extracellular Vesicles in Pharmaceutical Development: A European and Global Perspective. [PDF]

J Extracell Vesicles
Limongi T, Milla P, Stella B, Arpicco S.
europepmc   +1 more source

Advances in cell therapy for solid tumours: European perspective and future directions. [PDF]

Lancet Reg Health Eur
Moreno V, Thistlethwaite F, Yarza R, Tak WS, Lim KHJ, Haanen JBAG.   +5 more
europepmc   +1 more source

Rare disease clinical trials in Italy (2022-May 2026): current trends, future challenges, and the evolving role as reporting member state. [PDF]

Front Pharmacol
De Paola E, Galliccia F, Maione R, Verrelli NM, Dri DA.   +4 more
europepmc   +1 more source