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The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally.
- Published in:
- Drug Safety, 2024, v. 47, n. 5, p. 405, doi. 10.1007/s40264-024-01405-9
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- Publication type:
- Article
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance.
- Published in:
- Drug Safety, 2023, v. 46, n. 11, p. 1089, doi. 10.1007/s40264-023-01346-9
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- Publication type:
- Article
Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021.
- Published in:
- Drug Safety, 2023, v. 46, n. 10, p. 1007, doi. 10.1007/s40264-023-01341-0
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- Publication type:
- Article
Authors' Reply to Braillon and Martin's Comment on "Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)".
- Published in:
- 2021
- By:
- Publication type:
- letter
Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET).
- Published in:
- 2021
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- Publication type:
- journal article
Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe.
- Published in:
- Drug Safety, 2021, v. 44, n. 1, p. 63, doi. 10.1007/s40264-020-00993-6
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- Publication type:
- Article
Dissemination of Direct Healthcare Professional Communications on Medication Errors for Medicinal Products in the EU: An Explorative Study on Relevant Factors.
- Published in:
- Drug Safety, 2021, v. 44, n. 1, p. 73, doi. 10.1007/s40264-020-00995-4
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- Publication type:
- Article
Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2020, v. 29, n. 11, p. 1343, doi. 10.1002/pds.5133
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- Publication type:
- Article
EMA Recommendation for the Pediatric Indications of Plerixafor (Mozobil) to Enhance Mobilization of Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Children with Lymphoma or Malignant Solid Tumors.
- Published in:
- Oncologist, 2020, v. 25, n. 6, p. e976, doi. 10.1634/theoncologist.2019-0898
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- Publication type:
- Article
Improving the Safety of Medicines in the European Union: From Signals to Action.
- Published in:
- Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 3, p. 521, doi. 10.1002/cpt.1678
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- Publication type:
- Article
Pharmacovigilance 2030: Invited Commentary for the January 2020 "Futures" Edition of Clinical Pharmacology and Therapeutics.
- Published in:
- Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 1, p. 89, doi. 10.1002/cpt.1689
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- Publication type:
- Article
Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union.
- Published in:
- 2020
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- Publication type:
- journal article
Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action.
- Published in:
- 2018
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- Publication type:
- journal article
Latest clinical recommendations on valproate use for migraine prophylaxis in women of childbearing age: overview from European Medicines Agency and European Headache Federation.
- Published in:
- Journal of Headache & Pain, 2018, v. 19, n. 1, p. 1, doi. 10.1186/s10194-018-0898-3
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- Publication type:
- 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.
- Published in:
- 2018
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- Publication type:
- journal article
Is patient exposure preapproval and postapproval a determinant of the timing and frequency of occurrence of safety issues?
- Published in:
- Pharmacoepidemiology & Drug Safety, 2018, v. 27, n. 2, p. 168, doi. 10.1002/pds.4359
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- Publication type:
- Article
Decision making in drug safety-a literature review of criteria used to prioritize newly detected safety issues.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2017, v. 26, n. 3, p. 327, doi. 10.1002/pds.4128
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- Publication type:
- Article
The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: a simulation study.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2016, v. 25, n. 3, p. 297, doi. 10.1002/pds.3929
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- Publication type:
- Article
Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection.
- Published in:
- 2015
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- Publication type:
- journal article
The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study.
- Published in:
- British Journal of Clinical Pharmacology, 2015, v. 80, n. 2, p. 304, doi. 10.1111/bcp.12610
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- Publication type:
- Article
Understanding drug preferences, different perspectives.
- Published in:
- British Journal of Clinical Pharmacology, 2015, v. 79, n. 6, p. 978, doi. 10.1111/bcp.12566
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- Publication type:
- Article
Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project.
- Published in:
- PLoS ONE, 2015, v. 10, n. 6, p. 1, doi. 10.1371/journal.pone.0130399
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- Publication type:
- Article
Evaluating performance of electronic healthcare records and spontaneous reporting data in drug safety signal detection.
- Published in:
- International Journal of Clinical Pharmacy, 2015, v. 37, n. 1, p. 94, doi. 10.1007/s11096-014-0044-5
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- Publication type:
- Article
A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee.
- Published in:
- 2014
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- Publication type:
- journal article
Long-term use of 5α-reductase inhibitors and the risk of male breast cancer.
- Published in:
- 2014
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- Publication type:
- Report
Adherence to renal function monitoring guidelines in patients starting antihypertensive therapy with diuretics and RAAS inhibitors: a retrospective cohort study.
- Published in:
- 2014
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- Publication type:
- journal article
A population-based study on the prevalence and incidence of chronic kidney disease in the Netherlands.
- Published in:
- International Urology & Nephrology, 2014, v. 46, n. 3, p. 583, doi. 10.1007/s11255-013-0563-3
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- Publication type:
- Article
Post-Approval Safety Issues with Innovative Drugs: A European Cohort Study.
- Published in:
- Drug Safety, 2013, v. 36, n. 11, p. 1105, doi. 10.1007/s40264-013-0094-y
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- Publication type:
- Article
Additional risk minimisation measures in the EU- are they eligible for assessment?
- Published in:
- Pharmacoepidemiology & Drug Safety, 2013, v. 22, n. 10, p. 1046, doi. 10.1002/pds.3494
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- Publication type:
- Article
The Additional Value of an E-Mail to Inform Healthcare Professionals of a Drug Safety Issue: A Randomized Controlled Trial in the Netherlands.
- Published in:
- 2013
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- Publication type:
- journal article
Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases.
- Published in:
- Drug Safety, 2013, v. 36, n. 8, p. 617, doi. 10.1007/s40264-013-0073-3
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- Publication type:
- Article
Overanticoagulation is associated with renal function decline.
- Published in:
- Journal of Nephrology (JNonline), 2013, v. 26, n. 4, p. 691, doi. 10.5301/jn.5000280
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- Publication type:
- Article
Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis.
- Published in:
- PLoS Medicine, 2013, v. 10, n. 3, p. 1, doi. 10.1371/journal.pmed.1001407
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- Publication type:
- Article
Reasons for and time to discontinuation of rimonabant therapy: a modified prescription-event monitoring study.
- Published in:
- 2012
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- Publication type:
- journal article
Reasons for and Time to Discontinuation of Rimonabant Therapy A Modified Prescription-Event Monitoring Study.
- Published in:
- Drug Safety, 2012, v. 35, n. 12, p. 1147, doi. 10.2165/11631330-000000000-00000
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- Publication type:
- Article
Healthcare professionals' self-reported experiences and preferences related to direct healthcare professional communications: a survey conducted in the Netherlands.
- Published in:
- 2012
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- Publication type:
- journal article
Healthcare Professionals' Self-Reported Experiences and Preferences Related to Direct Healthcare Professional Communications. A Survey Conducted in the Netherlands.
- Published in:
- Drug Safety, 2012, v. 35, n. 11, p. 1061, doi. 10.2165/11635750-000000000-00000
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- Publication type:
- Article
Prescriptive contraceptive use among isotretinoin users in the Netherlands in comparison with non-users: a drug utilisation study.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2012, v. 21, n. 10, p. 1060, doi. 10.1002/pds.3200
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- Publication type:
- Article
Rituximab-induced thrombocytopenia: a cohort study.
- Published in:
- European Journal of Haematology, 2012, v. 89, n. 3, p. 256, doi. 10.1111/j.1600-0609.2012.01808.x
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- Publication type:
- Article
Concomitant Use of Contraceptives and Potentially Teratogenic Medicinal Products—Results From a Study Using Pharmacy Dispensing Data in the Netherlands.
- Published in:
- Reproductive Sciences, 2012, v. 19, n. 9, p. 987, doi. 10.1177/1933719112440050
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- Publication type:
- Article
Prescribing of rosiglitazone and pioglitazone following safety signals: analysis of trends in dispensing patterns in the Netherlands from 1998 to 2008.
- Published in:
- 2012
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- Publication type:
- journal article
Impact of safety-related regulatory action on clinical practice: a systematic review.
- Published in:
- 2012
- By:
- Publication type:
- journal article
Risk minimization activities of centrally authorized products in the EU: a descriptive study.
- Published in:
- 2012
- By:
- Publication type:
- journal article
Vaccine-based subgroup analysis in VigiBase: effect on sensitivity in paediatric signal detection.
- Published in:
- 2012
- By:
- Publication type:
- journal article
Lower risk of cancer in patients on metformin in comparison with those on sulfonylurea derivatives: results from a large population-based follow-up study.
- Published in:
- 2012
- By:
- Publication type:
- journal article
Lower Risk of Cancer in Patients on Metformin in Comparison With Those on Sulfonylurea Derivatives.
- Published in:
- Diabetes Care, 2012, v. 35, n. 1, p. 119, doi. 10.2337/dc11-0857
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- Publication type:
- Article
Implementation of the harmonized EU isotretinoin Pregnancy Prevention Programme: a questionnaire survey among European regulatory agencies.
- Published in:
- 2012
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- Publication type:
- journal article
Selective serotonin re-uptake inhibiting antidepressants and the risk of overanticoagulation during acenocoumarol maintenance treatment.
- Published in:
- British Journal of Clinical Pharmacology, 2011, v. 72, n. 5, p. 798, doi. 10.1111/j.1365-2125.2011.04004.x
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- Publication type:
- Article
Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.
- Published in:
- 2011
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- Publication type:
- journal article
Additional safety risk to exceptionally approved drugs in Europe?
- Published in:
- British Journal of Clinical Pharmacology, 2011, v. 72, n. 3, p. 490, doi. 10.1111/j.1365-2125.2011.03995.x
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- Publication type:
- Article