Zobrazeno 1 - 7
of 7
pro vyhledávání: '"Bert van Leeuwen"'
Autor:
Marco Sardella, Glyn Belcher, Calin Lungu, Terenzio Ignoni, Manuela Camisa, Doris Irene Stenver, Paolo Porcelli, Margherita D’Antuono, Nicola Gian Castiglione, Anna Adams, Giovanni Furlan, Ilaria Grisoni, Sarah Hall, Laura Boga, Valentina Mancini, Mircea Ciuca, David Chonzi, Brian Edwards, Arduino A Mangoni, Marco Tuccori, Elena Prokofyeva, Fabio De Gregorio, Mario Bertazzoli Grabinski Broglio, Bert van Leeuwen, Paola Kruger, Christian Rausch, Hervé Le Louet
Publikováno v:
Therapeutic Advances in Drug Safety, Vol 12 (2021)
The collection and assessment of individual case safety reports (ICSRs) is important to detect unknown adverse drug reactions particularly in the first decade after approval of new chemical entities. However, regulations require that these activities
Externí odkaz:
https://doaj.org/article/e2f577c0d23646f1bd9f7bce36bd7551
Autor:
Fabio De Gregorio, Arduino A. Mangoni, Giovanni Furlan, Terenzio Ignoni, Marco Tuccori, Hervé Le Louet, Bert van Leeuwen, Nicola Gian Castiglione, Manuela Camisa, Marco Sardella, Anna L. Adams, Paolo Porcelli, Doris Irene Stenver, Glyn Belcher, Elena Prokofyeva, Valentina Mancini, Brian Edwards, Ilaria Grisoni, Mircea Ciuca, Mario Bertazzoli Grabinski Broglio, Margherita D'Antuono, David Chonzi, Laura Boga, Calin Lungu, Christian Rausch, Paola Kruger, Sarah Hall
Publikováno v:
Therapeutic Advances in Drug Safety, Vol 12 (2021)
Therapeutic Advances in Drug Safety
Therapeutic Advances in Drug Safety
The collection and assessment of individual case safety reports (ICSRs) is important to detect unknown adverse drug reactions particularly in the first decade after approval of new chemical entities. However, regulations require that these activities
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f34816c4fd72bc7af4a6d65be312bb09
https://doaj.org/article/e2f577c0d23646f1bd9f7bce36bd7551
https://doaj.org/article/e2f577c0d23646f1bd9f7bce36bd7551
Publikováno v:
Pharmaceutical Medicine. 31:75-80
Over the last approximately 20 years, the pharmaceutical industry has increasingly outsourced its research and development activities, including pharmacovigilance, with mixed results. To avoid significant failures, both clients and service providers
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::347639a6a6aef5a8c1695031a17ba8b4
https://doi.org/10.1007/s40290-017-0183-9
https://doi.org/10.1007/s40290-017-0183-9
Publikováno v:
Therapeutic Innovation & Regulatory Science. 51:11-15
Outsourcing in pharmacovigilance has grown in the past decade. However, standards are lacking in this area, both for initiating as well as maintaining an outsource relationship. In this paper, the authors propose that the sector can learn from other
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0e1ab20bb77f9d4699a0c3bf9ad0655d
https://doi.org/10.1177/2168479016659518
https://doi.org/10.1177/2168479016659518
Autor:
Ulrich Chin-Kon-Sung, Celeste Holbrook, Laurence Allard-Schrijer, G. Stefansdottir, Jean Benjoya, Keiko Ohga, Colette F. Saccomanno, Vaishali Patadia, Bert van Leeuwen, David Nimke
Publikováno v:
Pharmaceutical Medicine. 29:197-201
In 2012, the European Medicines Agency published guidelines for good pharmacovigilance practices. Within these guidelines, the Agency advised that marketing authorization holders (MAHs) establish safety signal tracking systems that capture outcomes r
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::3a616177331b023b8892478857fbf2b7
https://doi.org/10.1007/s40290-015-0107-5
https://doi.org/10.1007/s40290-015-0107-5
Publikováno v:
SAE Technical Paper Series.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8a5a0bf523a8e42a4aaff7f316ae9118
https://doi.org/10.4271/2014-01-1651
https://doi.org/10.4271/2014-01-1651
Autor:
Bert van Leeuwen
Publikováno v:
The Lancet. 361:527
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fbc7642beb1a7ca4b6116c49a4f0814b
https://doi.org/10.1016/s0140-6736(03)12471-3
https://doi.org/10.1016/s0140-6736(03)12471-3