Results 81 to 90 of about 7,238,985 (145)

Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency

Frontiers in Medicine
IntroductionThe study examines the impact of regulatory tools, including PRIority MEdicines (PRIME) scheme, on the marketing authorization (MA) timeline of advanced therapy medicinal products (ATMPs) approved by the European Medicines Agency (EMA ...
Simonita Alaburde, Justinas Ivaska, Justinas Ivaska, Greta Kaspute, Tatjana Ivaskiene   +4 more
doaj   +1 more source

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.
Junnan Shi, Xianwen Chen, Hao Hu, Carolina Oi Lam Ung   +3 more
doaj   +1 more source

Advanced therapy medicinal products (ATMPs) - An analysis of the global regulatory status. [PDF]

Br J Clin Pharmacol
Cramer A, Sørup FKH, Lund M, Petersen TS, Karstoft K.   +4 more
europepmc   +1 more source

Advanced therapy medicinal products are coming of age: A pipeline analysis of the clinical trial landscape

Advanced therapy medicinal products (ATMPs) are a unique class of biological medicines that are based on cells, genes, or tissues. Searching four databases, this analysis identified 2008 trials that investigated ATMPs and characterised them according to ...
Vanhaeren, Michiel, Dyck, Walter Van, Simoens, Steven, Huys, Isabelle, Gijsbers, Rik   +4 more
core   +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

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

Expanding Patient Access to Advanced Therapies. [PDF]

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

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

Individualized pharmacotherapy: background and development. [PDF]

Ann Transl Med
Jørgensen JT, Westergaard N.
europepmc   +1 more source