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Your search keyword '"Moors, Ellen H M"' showing total 7 results
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7 results on '"Moors, Ellen H M"'

1. Successful implementation of self-management health innovations

Author

Innovation and Sustainability, Innovation Studies, van Beest, Wilke, Boon, Wouter P. C., Andriessen, Daan, Moors, Ellen H. M., van der Veen, Gerrita, Pol, Harald, Innovation and Sustainability, Innovation Studies, van Beest, Wilke, Boon, Wouter P. C., Andriessen, Daan, Moors, Ellen H. M., van der Veen, Gerrita, and Pol, Harald

Published
2022

2. Tradition, not science, is the basis of animal model selection in translational and applied research

Author

Afd Pharmaceutics, Innovation and Sustainability, Innovation Studies, Pharmaceutics, Veening-Griffioen, Désirée H, Ferreira, Guilherme S, Boon, Wouter P C, Gispen-de Wied, Christine C, Schellekens, Huub, Moors, Ellen H M, Van Meer, Peter J K, Afd Pharmaceutics, Innovation and Sustainability, Innovation Studies, Pharmaceutics, Veening-Griffioen, Désirée H, Ferreira, Guilherme S, Boon, Wouter P C, Gispen-de Wied, Christine C, Schellekens, Huub, Moors, Ellen H M, and Van Meer, Peter J K

Published
2021

4. The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals

Author

Sub Biotechnological drugs, Sub IMW afd IW Overige, Sub Pharmacotherapy, Theoretical, Innovation and Sustainability, Sub Pharmacoepidemiology, Ebbers, Hans C, Mantel-Teeuwisse, Aukje K, Sayed-Tabatabaei, Fakhredin A, Moors, Ellen H M, Schellekens, Huub, Leufkens, Hubert G M, Sub Biotechnological drugs, Sub IMW afd IW Overige, Sub Pharmacotherapy, Theoretical, Innovation and Sustainability, Sub Pharmacoepidemiology, Ebbers, Hans C, Mantel-Teeuwisse, Aukje K, Sayed-Tabatabaei, Fakhredin A, Moors, Ellen H M, Schellekens, Huub, and Leufkens, Hubert G M

Published
2013

5. A cohort study exploring determinants of safety-related regulatory actions for biopharmaceuticals

Author

Sub Biotechnological drugs, Sub Pharmacotherapy, Theoretical, Section Innovation Studies, Sub Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology, Pharmaceutics, Innovation Studies, Ebbers, Hans C, Mantel-Teeuwisse, Aukje K, Moors, Ellen H M, Sayed Tabatabaei, Fakhredin A, Schellekens, Huub, Leufkens, Hubert G M, Sub Biotechnological drugs, Sub Pharmacotherapy, Theoretical, Section Innovation Studies, Sub Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology, Pharmaceutics, Innovation Studies, Ebbers, Hans C, Mantel-Teeuwisse, Aukje K, Moors, Ellen H M, Sayed Tabatabaei, Fakhredin A, Schellekens, Huub, and Leufkens, Hubert G M

Published
2012

6. Today's challenges in pharmacovigilance: what can we learn from epoetins?

Author

Sub Biotechnological drugs, Sub Pharmacotherapy, Theoretical, Section Innovation Studies, Sub Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology, Pharmaceutics, Ebbers, Hans C, Mantel-Teeuwisse, Aukje K, Moors, Ellen H M, Schellekens, Huub, Leufkens, Hubert G, Sub Biotechnological drugs, Sub Pharmacotherapy, Theoretical, Section Innovation Studies, Sub Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology, Pharmaceutics, Ebbers, Hans C, Mantel-Teeuwisse, Aukje K, Moors, Ellen H M, Schellekens, Huub, and Leufkens, Hubert G

Published
2011

7. The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals.

Author

Ebbers HC, Mantel-Teeuwisse AK, Sayed-Tabatabaei FA, Moors EH, Schellekens H, and Leufkens HG

Subjects
Adverse Drug Reaction Reporting Systems, Drug Labeling, Humans, Biological Products adverse effects, Product Surveillance, Postmarketing
Abstract

Purpose: To describe and assess the outcomes of Periodic Safety Update Report (PSUR) evaluations of biopharmaceuticals., Methods: A cross-sectional analysis was performed of follow-up requirements of PSURs submitted for centrally approved biopharmaceuticals in the European Union between 1 July 2008 and 30 June 2010. A follow-up analysis on a subset of products that submitted multiple PSURs within the study period was also performed., Results: The cross-sectional analysis included 70 PSURs. Potential safety concerns occurred in 57 (83 %) of all PSURs, and 26 (37 %) concluded a need to change the Summary of Product Characteristics (SPC). In comparison to newer products, products authorized for more than 10 years contained significantly fewer potential safety concerns (60 vs. 92 %; p < 0.01) and required fewer SPC changes (15 vs. 46 %; p = 0.03). For 45 products, multiple PSURs were submitted that could be included in a follow-up analysis. For this subset of products, of the 106 newly identified safety potential safety issues, 7 (7%) resulted in requirements for label changes in the following PSUR., Conclusions: PSURs facilitate communication between regulators and marketing authorization holders. Potential safety concerns occur for the majority of biopharmaceuticals and throughout their lifecycle, but for established products PSUR evaluations rarely lead to regulatory actions.

Published
2013
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