Zobrazeno 1 - 8
of 8
pro vyhledávání: '"Winona Rei Bolislis"'
Autor:
Thomas C, Kühler, Marc, Schoenmakers, Oliver, Shergold, Stephan, Affolter, Winona Rei, Bolislis, Ruth, Foster, Paul, Gardner, Svenja, Hruschka, Thierry, Jomini, Sathish, Kaveripakam, Karl, Mayerhofer, Tomaso, Scherini, Marta, Swierczynska, Gretchen, Vandal, Shayesteh, Fürst-Ladani
Publikováno v:
Clinical Therapeutics. 44:768-782
Patients taking a medicinal product in a homecare setting typically use a medical device to facilitate the injection process. Reductions in wireless connectivity costs, combined with the rapid adoption of smartphones with connectivity to cloud-based
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::956f40245051f174073cbd135e644048
https://doi.org/10.1016/j.clinthera.2022.03.009
https://doi.org/10.1016/j.clinthera.2022.03.009
Autor:
Cyril Hardit, Julien Parain, Makoto Nagaoka, Clive Brading, Sarah Mofid, Winona Rei Bolislis, Maria Zanta, Nigel Hamilton, Thomas C. Kühler
Publikováno v:
Clinical Therapeutics
Purpose The COVID-19 pandemic has affected the management and operation of regulatory agencies and the pharmaceutical industry around the world. It has prompted regulatory authorities to consider new ways of working and introduced, among others, remo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a01245595b24342e0f9b20ac3d3fd1b9
https://doi.org/10.1016/j.clinthera.2021.10.003
https://doi.org/10.1016/j.clinthera.2021.10.003
Autor:
Makoto Nagaoka, Thomas C. Kühler, Winona Rei Bolislis, May Li Woon, Maria Lucia de Lucia, Felipe Dolz, Heraclio Rodriguez, Runyi Mo, Wei Yu
Publikováno v:
Clinical Therapeutics
Purpose Critical steps have been adopted by health and regulatory authorities around the world to respond to the COVID-19 pandemic. The authors aim to highlight these by providing an overview of the regulatory approaches adopted during the onset of t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::846307b9bbe381a4b120c8175a56a972
https://doi.org/10.1016/j.clinthera.2020.11.015
https://doi.org/10.1016/j.clinthera.2020.11.015
Publikováno v:
Clinical therapeutics. 44(2)
This article provides an analysis of the various regulatory decisions available in the public domain that suggest the use of real-world data (RWD) for postmarketing surveillance activities of products that have a marketing authorization approved by t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4578f9910d7f7136141c93abc57db214
https://pubmed.ncbi.nlm.nih.gov/35074209
https://pubmed.ncbi.nlm.nih.gov/35074209
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
Autor:
Paul-Etienne Schaeffer, Thomas C. Kühler, Charlie Mortazavi, Winona Rei Bolislis, Rossana Riccioni
Publikováno v:
Therapeutic Innovation & Regulatory Science
Patient information leaflets (PILs) differ across regulatory jurisdictions—its form and structure are dependent on the regulations it conforms to. Yet, physical or paper-based documents remain to be the most prevalent way of delivering important in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::97308c346f2caabc352304505938195b
http://europepmc.org/articles/PMC7362886
http://europepmc.org/articles/PMC7362886
Publikováno v:
Clinical therapeutics. 42(5)
Purpose For this article, the authors compiled, summarized, and analyzed data from 27 cases in which real-world data (RWD) were applied in regulatory approval. The aims were to provide an overview of RWD, based on classifications per therapeutic area
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fb01621c2eeed5b9253840d638ab7a54
https://pubmed.ncbi.nlm.nih.gov/32340916
https://pubmed.ncbi.nlm.nih.gov/32340916
Autor:
Zoe Dayan, Winona Rei Bolislis
Publikováno v:
OECD Regulatory Policy Working Papers.
Business registration is crucial for ensuring accountable, transparent and viable business environments. By bringing businesses into the formal economy, governments are able to provide more strategic and targeted policies for businesses and consumers
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::d758adbaf5843cdf632c7c0cfd4f5e8b
https://doi.org/10.1787/971154c7-en
https://doi.org/10.1787/971154c7-en