Results 11 to 20 of about 80,109 (188)

Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective [PDF]

CPT: Pharmacometrics & Systems Pharmacology, 2023
Model- informed drug development (MIDD) approaches receive wide regulatory acceptance in the European Medicines Agency (EMA) to support new drug devel-opment.
Efthymios Manolis, Alfredo García‐Arieta, Anders Lindahl, Evangelos Kotzagiorgis, Jobst Limberg, Øyvind Holte, Paulo Paixao, Carolien Versantvoort, Flora Musuamba Tshinanu, Kevin Blake, Michiel Van Den Heuvel   +10 more
doaj   +3 more sources

The European Medicines Agency: a public health European agency?

Medicine and law, 2012
The European Medicines Agency (EMA) is a European Agency as it is a decentralized body governed by European public law; it has its own legal personality and is also distinct from the European Union institutions (Council, Parliament, Commission, etc.). The EMA presents itself, and is commonly recognised, as a public health agency.
Mahalatchimy, Aurélie, Rial-Sebbag, Emmanuelle, de Grove-Valdeyron, Nathalie, Tournay, Virginie, Cambon-Thomsen, Anne, Duguet, Anne-Marie, Taboulet, Florence   +6 more
core   +4 more sources

A bacteriophage journey at the European Medicines Agency [PDF]

FEMS Microbiology Letters, 2015
The seriously and globally increasing bacterial multi-drug resistance calls out on concerted counteractive measures: international health authorities give consideration to the therapeutical use of bacteriophage therapy.
Debarbieux, Laurent, Pirnay, Jean-Paul, Verbeken, Gilbert, de Vos, Daniel, Merabishvili, Maia, Huys, Isabelle, Patey, Olivier, Schoonjans, Dirk, Vaneechoutte, Mario, Zizi, Martin, Rohde, Christine   +10 more
openaire   +5 more sources

Patient-Reported Outcome Measures in Oncology Drugs Approved by the European Medicines Agency, 2017-2021.

JAMA Netw Open, 2023
The strategic vision of the European Medicines Agency (EMA) seeks to reinforce patient relevance in evidence generation for pharmaceutical products through a coordinated approach to PROMs collection.
Ciani O, Meregaglia M, De Lorenzo F, Perrone F, Pinto C.   +4 more
europepmc   +2 more sources

Populations Addressed in Vaccines Approved via the European Medicines Agency. [PDF]

Clin Pharmacol Ther
Therapeutic and prophylactic agents require robust evidence before patient use. Randomized controlled trials are essential for evaluating safety and efficacy but often exclude specific populations that are also targets for the intervention.
Gräf DD, Westphal L, Kimmelman J, Hallgreen CE.   +3 more
europepmc   +2 more sources

Safety Monitoring of COVID-19 Vaccines: Perspective from the European Medicines Agency. [PDF]

Clin Pharmacol Ther, 2023
Prior to deployment of coronavirus disease 2019 (COVID-19) vaccines in the European Union in 2021, a high vaccine uptake leading to an unprecedented volume of safety data from spontaneous reports and real-world evidence, was anticipated.
Durand J, Dogné JM, Cohet C, Browne K, Gordillo-Marañón M, Piccolo L, Zaccaria C, Genov G.   +7 more
europepmc   +3 more sources

Which clinical trial designs and statistical approaches have been used in assessments of orphan maintenance by the European Medicines Agency between 2012 and 2022? A cross-sectional study. [PDF]

BMJ Open
Objectives In the European Union, a new orphan medicinal product must demonstrate ‘significant benefit’ over approved medicinal products targeting the same indication.
Fabian Windfuhr, Kristina Larsson, Theodor Framke, Florian Lasch   +3 more
doaj   +2 more sources

Methodological Insights on Biomarker-Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency. [PDF]

Clin Pharmacol Ther
Biomarkers play a pivotal role in the selection and enrollment of trial participants. Particularly, predictive biomarkers help tailor medical care to individual patients; however, also prognostic biomarkers require consideration at the design stage.
Huber C, Zinserling J, Benda N, Vetter T, Rueckbeil M.   +4 more
europepmc   +2 more sources

The impact of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) to address shortages of human and veterinary medicines across Europe [PDF]

Frontiers in Public Health
Shortages of medicines are a global public health challenge with a significant impact on patient care. While the issue is at the top of the agenda of EU policymakers, regulators and healthcare providers, shortages are a complex problem with many ...
Inga Abed, Vanessa Bennett, Brendan Cuddy, Sandra Dang, Juan García Burgos, Domenico Di Giorgio, Maria Lamas, Momir Radulovic, Nuno Simões, Rui Santos Ivo, Hugues Malonne, Monica Dias   +11 more
doaj   +2 more sources

The European Medicines Agency and The Lancet Regional Health—Europe join forces to protect public health [PDF]

The Lancet Regional Health. Europe
Juan Garcia Burgos, Steffen Thirstrup, Emer Cooke   +2 more
doaj   +2 more sources