Zobrazeno 1 - 8
of 8
pro vyhledávání: '"Angelika Joos"'
Publikováno v:
Frontiers in Medicine, Vol 10 (2023)
Regulatory harmonization and convergence have been identified as the key driver in promoting efficient evaluation of medicines, reducing workload, and supporting earlier access to medicines on the African continent. There has been great progress to d
Externí odkaz:
https://doaj.org/article/83365f8d786e49469a46969d59a70112
Autor:
Leon Rohde, Elias Mossialos, Charlotte Beaudart, Angelika Joos, Inka Heikkinen, Silas Holland, Mickaël Hiligsmann
Publikováno v:
Journal of Global Antimicrobial Resistance, Vol 29, Iss , Pp 42-48 (2022)
ABSTRACT: Objectives: Without intervention, experts predict that antimicrobial resistance will rank among leading drivers of mortality by 2050. New drugs are desperately needed, but given the lengthy development timelines for antimicrobial research a
Externí odkaz:
https://doaj.org/article/53b0290b8f85414790f3513cb19b1579
Autor:
Claire Hill-Venning, Thomas C. Kühler, David King, Hans Hoogland, Solange Corriol-Rohou, Angelika Joos, Genevieve Le Visage, Winona Rei Bolislis, Victoria Kitcatt
Publikováno v:
Clinical Therapeutics. 41:2630-2642
Purpose European policy makers have provided a number of incentives for the development of medicines for orphan diseases as early as 1999 through the Orphan Regulation and created obligations for medicines developers to investigate their products in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::70d25fb3b4b15565267a9777303d780f
https://doi.org/10.1016/j.clinthera.2019.10.006
https://doi.org/10.1016/j.clinthera.2019.10.006
Publikováno v:
International Journal of Technology Assessment in Health Care, 37(1):40. Cambridge University Press
Objective This study aims to assess stakeholder perceptions on the challenges and value of real-world evidence (RWE) post approval, the differences in regulatory and health technology assessment (HTA) real-world data (RWD) collection requirements und
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cb15a61a645cf99919b87a1de910b7ed
https://cris.maastrichtuniversity.nl/en/publications/137a5d48-f298-4588-bf6b-7b58acdb5e5a
https://cris.maastrichtuniversity.nl/en/publications/137a5d48-f298-4588-bf6b-7b58acdb5e5a
Publikováno v:
International Journal of Technology Assessment in Health Care, 34(5), 514-518. Cambridge University Press
Objectives:This study aims to assess participants’ views on previous experiences, the current situation and future perspectives for early dialogue between the pharmaceutical industry, a regulatory agency and health technology assessment bodies (HTA
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::67e36fc4d8f091baea75e4fd3b76378d
https://pubmed.ncbi.nlm.nih.gov/30246671
https://pubmed.ncbi.nlm.nih.gov/30246671
Autor:
Claire Beggs, Thomas Visalli, Martin Bopst, Angelika Joos, Fraser Stodart, Susanne Ausborn, Claus-Dieter Schiller, Lilia Smirnova, Olga Kovbasenco, Natalia Semenova, Lisette Vromans, Martina Schwinger, Joerg H.O. Garbe, Alexandra A. Kitashova
Publikováno v:
Journal of Pharmaceutical Sciences
In the early 1900s, the abnormal toxicity test (ATT) was developed as an auxiliary means to ensure safe and consistent antiserum production. Today, the ATT is utilized as a quality control (QC) release test according to pharmacopoeial or other regula
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::135fea7762c9ff64942b083ac2e072dc
https://doi.org/10.1002/jps.24125
https://doi.org/10.1002/jps.24125
Autor:
William W. Chin, Angelika Joos
Publikováno v:
European journal of pediatrics. 175(12)
Over the past two decades, there has been growing concern over the lack of proper medication for children. This review attempts to evaluate the current progress of EU Pediatric Regulation made since 2007. The lack of properly evaluated pediatric medi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c79c5059ab6deda1d190c5264646c6ce
https://pubmed.ncbi.nlm.nih.gov/27646479
https://pubmed.ncbi.nlm.nih.gov/27646479
Autor:
Marc Boutin, Veronica Todaro, Graeme Johnston, Roslyn F. Schneider, Jan Geissler, Lode Dewulf, Gervais Tougas, Ifeanyi Sargeant, James Anderson, Angelika Joos, Anton Hoos, Marilyn Metcalf, Jeanne M. Regnante
Publikováno v:
Therapeutic Innovation & Regulatory Science
The purpose of medicines is to improve patients' lives. Stakeholders involved in the development and lifecycle management of medicines agree that more effective patient involvement is needed to ensure that patient needs and priorities are identified
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0d9ddcee323eaaed80669e15e6234a82
https://pubmed.ncbi.nlm.nih.gov/26539338
https://pubmed.ncbi.nlm.nih.gov/26539338