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European Medicines Agency seeks stakeholders' views on future transparency measures for clinical trials.
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- British Journal of Clinical Pharmacology, 2023, v. 89, n. 8, p. 2338, doi. 10.1111/bcp.15825
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HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real‐world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.
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- Pharmacoepidemiology & Drug Safety, 2023, v. 32, n. 1, p. 44, doi. 10.1002/pds.5507
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A natural language processing approach towards harmonisation of European medicinal product information.
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- PLoS ONE, 2022, v. 17, n. 10, p. 1, doi. 10.1371/journal.pone.0275386
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Real‐World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value.
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- Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 21, doi. 10.1002/cpt.2479
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- Article
The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions.
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- Drug Safety, 2022, v. 45, n. 1, p. 83, doi. 10.1007/s40264-021-01137-0
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- Article
The Certainty Framework for Assessing Real‐World Data in Studies of Medical Product Safety and Effectiveness.
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- Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 5, p. 1189, doi. 10.1002/cpt.2045
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- Article
Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth.
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- Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 5, p. 1212, doi. 10.1002/cpt.2083
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What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring?
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- Pharmacoepidemiology & Drug Safety, 2021, v. 30, n. 3, p. 334, doi. 10.1002/pds.5162
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- Article
Does additional monitoring status increase the reporting of adverse drug reactions? An interrupted time series analysis of EudraVigilance data.
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- Pharmacoepidemiology & Drug Safety, 2021, v. 30, n. 3, p. 350, doi. 10.1002/pds.5174
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- Article
International Collaboration in Real‐World Evidence Generation for Direct Acting Oral Anti‐Coagulants.
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- Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 299, doi. 10.1002/cpt.1999
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- Article
Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements.
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- 2021
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- journal article
Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use.
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- Pharmacoepidemiology & Drug Safety, 2020, v. 29, n. 11, p. 1343, doi. 10.1002/pds.5133
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- Article
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.
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- British Journal of Clinical Pharmacology, 2020, v. 86, n. 6, p. 1034, doi. 10.1111/bcp.14279
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- Article
Measuring the impact of risk communications: Robust analytical approaches are key.
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- British Journal of Clinical Pharmacology, 2020, v. 86, n. 4, p. 635, doi. 10.1111/bcp.14222
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- Article
Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.
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- Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 4, p. 773, doi. 10.1002/cpt.1638
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- Article
Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?: A Validation Study Based on Prescribing Codeine in Children.
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- Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 4, p. 915, doi. 10.1002/cpt.1785
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- Article
Ability of Primary Care Health Databases to Assess Medicinal Products Discussed by the European Union Pharmacovigilance Risk Assessment Committee.
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- Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 4, p. 957, doi. 10.1002/cpt.1775
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Improving the Safety of Medicines in the European Union: From Signals to Action.
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- Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 3, p. 521, doi. 10.1002/cpt.1678
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Pharmacovigilance 2030: Invited Commentary for the January 2020 "Futures" Edition of Clinical Pharmacology and Therapeutics.
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- Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 1, p. 89, doi. 10.1002/cpt.1689
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A European multicentre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children.
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- Pharmacoepidemiology & Drug Safety, 2019, v. 28, n. 8, p. 1086, doi. 10.1002/pds.4836
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Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe.
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- Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 36, doi. 10.1002/cpt.1426
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Building an Evidence Base on the Place of Industry-Sponsored Programs in Drug Safety Surveillance.
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- 2019
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- journal article
Graphical Depiction of Longitudinal Study Designs in Health Care Databases.
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- 2019
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- journal article
EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection.
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- 2018
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- journal article
Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs.
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- 2018
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- journal article
Is patient exposure preapproval and postapproval a determinant of the timing and frequency of occurrence of safety issues?
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- Pharmacoepidemiology & Drug Safety, 2018, v. 27, n. 2, p. 168, doi. 10.1002/pds.4359
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- Article
An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance.
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- Pharmacoepidemiology & Drug Safety, 2018, v. 27, n. 1, p. 38, doi. 10.1002/pds.4344
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- Article
Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.
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- Pharmacoepidemiology & Drug Safety, 2017, v. 26, n. 12, p. 1442, doi. 10.1002/pds.4196
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Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works.
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- 2017
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- journal article
Patient Reporting in the EU: Analysis of EudraVigilance Data.
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- 2017
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- journal article
Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention.
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- 2016
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- journal article
Geographical variation in reporting Interstitial Lung Disease as an adverse drug reaction: findings from an European Medicines Agency analysis of reports in EudraVigilance.
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- Pharmacoepidemiology & Drug Safety, 2016, v. 25, n. 6, p. 705, doi. 10.1002/pds.3998
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- Article
Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection.
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- 2015
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- journal article
The US Food and Drug Administration-European Medicines Agency collaboration in pharmacovigilance: common objectives and common challenges.
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- 2015
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- journal article
Periodic Benefit-Risk Evaluation Report: A European Union Regulatory Perspective.
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- Pharmaceutical Medicine, 2014, v. 28, n. 6, p. 309, doi. 10.1007/s40290-014-0071-5
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- Article
Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee.
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- Nature Reviews Drug Discovery, 2014, v. 13, n. 5, p. 395, doi. 10.1038/nrd3713-c1
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- Article
The European Medicines Agency's use of prioritised independent research for best evidence in regulatory action on diclofenac.
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- Pharmacoepidemiology & Drug Safety, 2014, v. 23, n. 4, p. 431, doi. 10.1002/pds.3594
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- Article
Benefit Risk Management Plans?
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- Pharmaceutical Medicine, 2013, v. 27, n. 1, p. 5, doi. 10.1007/s40290-012-0001-3
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Evaluation of the effectiveness of risk minimization measures.
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- Pharmacoepidemiology & Drug Safety, 2012, v. 21, n. 8, p. 896, doi. 10.1002/pds.3305
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Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
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- Pharmacoepidemiology & Drug Safety, 2012, v. 21, n. 7, p. 690, doi. 10.1002/pds.3281
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European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.
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- Pharmacoepidemiology & Drug Safety, 2011, v. 20, n. 10, p. 1021, doi. 10.1002/pds.2209
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- Article