Zobrazeno 1 - 8
of 8
pro vyhledávání: '"Dominic, Way"'
Publikováno v:
Risk Analysis. 35:1210-1229
In recent years, European pharmaceutical regulators have increasingly committed to heightening access to raw safety-related data as part of a wave of transparency initiatives (e.g., providing public Internet-mediated access to clinical trials data).
Autor:
Dominic Way, Ragnar Lofstedt
Publikováno v:
Journal of Risk Research. 19:1120-1128
Since writing and submitting our draft article on transparency and trust in the European pharmaceutical sector, the pace towards still greater ‘fishbowl’ transparency has sped up. On the 2nd of Apr...
Publikováno v:
Drug Safety
Drug Safety, Springer Verlag, 2017, 40 (1), pp.15-36. ⟨10.1007/s40264-016-0466-1⟩
Drug Safety, 40(1), 15-36. Adis International Ltd
Drug Safety, Springer Verlag, 2017, 40 (1), pp.15-36. ⟨10.1007/s40264-016-0466-1⟩
Drug Safety, 40(1), 15-36. Adis International Ltd
International audience; This paper reviews the main tools for communicating benefit–risk medicines information to patients that are used, or could be used, by pharmaceutical regulators. One highly successful tool from the food safety sector (front-
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b11679986d653d12ebcfe37865ab4839
https://hal-mines-paristech.archives-ouvertes.fr/hal-01411682
https://hal-mines-paristech.archives-ouvertes.fr/hal-01411682
Autor:
Dominic Way, Ragnar Lofstedt
Publikováno v:
Journal of Risk Research. 19:1082-1103
Many European pharmaceutical regulators have committed to a more open, inclusive, and transparent model of regulatory decision-making in recent years. Yet, based on little empirical evidence, they have overwhelmingly adopted ‘fishbowl’ transparen
Publikováno v:
Journal of Risk Research, 19(9), 1185-1215. Routledge/Taylor & Francis Group
Balog-Way, D, Bouder, F, Lofstedt, R E V & Evensen, D 2016, ' Medicines transparency at the European Medicines Agency (EMA) in the new information age: the perspectives of patients ', Journal of Risk Research, pp. 1-31 . https://doi.org/10.1080/13669877.2016.1200652
Balog-Way, D, Bouder, F, Lofstedt, R E V & Evensen, D 2016, ' Medicines transparency at the European Medicines Agency (EMA) in the new information age: the perspectives of patients ', Journal of Risk Research, pp. 1-31 . https://doi.org/10.1080/13669877.2016.1200652
The concept of transparency has gained widespread appeal in the European pharmaceutical domain, not least at the European Medicines Agency (EMA). Agency policies have two main objectives: (1) to enable the reuse of data (e.g. clinical study reports)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5b4e794093b5f3850f90ab647426f779
https://cris.maastrichtuniversity.nl/en/publications/1b17b823-a403-4d88-828c-b78370b06348
https://cris.maastrichtuniversity.nl/en/publications/1b17b823-a403-4d88-828c-b78370b06348
Publikováno v:
Risk analysis : an official publication of the Society for Risk Analysis. 35(7)
In recent years, European pharmaceutical regulators have increasingly committed to heightening access to raw safety-related data as part of a wave of transparency initiatives (e.g., providing public Internet-mediated access to clinical trials data).
Publikováno v:
Clinical Therapeutics. 37:e161-e162
Autor:
Helga Gardarsdottir, Agnes Kant, Marie Louise (Marieke) De Bruin, Ce, Hallgreen, Gerald Dal Pan, Dominic Way
Publikováno v:
University of Copenhagen
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::9594385071fb237da8cbb6c16e702c60
https://curis.ku.dk/portal/en/publications/how-to-measure-the-impact-of-pharmacovigilance-activities-on-public-health(5732f416-33da-4f44-abc7-f1f8c517e2ef).html
https://curis.ku.dk/portal/en/publications/how-to-measure-the-impact-of-pharmacovigilance-activities-on-public-health(5732f416-33da-4f44-abc7-f1f8c517e2ef).html