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Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making
Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making
Pharmacovigilance involves a continuous process of evaluating, monitoring and communicating the safety profile of a medici...
Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study
Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study
Effectiveness and respiratory adverse events following coronavirus disease-2019 (COVID-19) vaccines have not been well inv...
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
For signal detection studies investigating either drug safety or method evaluation, the choice of drug-outcome pairs needs...
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
Health technology assessment (HTA) is a multidisciplinary process that determines the value of health technology at differ...
Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project
Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project
The ConcePTION project aims to improve the way medication use during pregnancy is studied. This includes exploring the pos...
Appeal for Increasing the Impact of Pharmacovigilance
Appeal for Increasing the Impact of Pharmacovigilance
Pharmacovigilance (PV) is defined as the science and activities related to detecting, assessing, understanding and prevent...
International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries
International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries
Adverse drug events (ADEs) are becoming a significant public health issue. However, reports on ADE-related mortality are l...
Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study
Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study
Combined anticoagulant-antiplatelet therapy is often indicated in adults with cardiovascular disease and atrial fibrillati...
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes
Sodium–glucose cotransporter 2 (SGLT2) inhibitors are a relatively new class of antihyperglycemic agents, with the p...
Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing
Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing
The Vaccine Adverse Event Reporting System (VAERS) has already been challenged by an extreme increase in the number of ind...
The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness
The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness
The use of artificial intelligence (AI)-based tools to guide prescribing decisions is full of promise and may enhance pati...
The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs)
The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs)
In general, poor communication between patients and HCPs is another reason for under-reporting. In addition, poor or ineff...
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry
Published data on the safety of natural medical cannabis (MC) when used in the real-world clinical practice setting are la...
An Overview of Regression Models for Adverse Events Analysis
An Overview of Regression Models for Adverse Events Analysis
Over the last few years, several review articles described the adverse events analysis as sub-optimal in clinical trials. ...
Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers
Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers
Adverse drug reactions (ADRs) can be reported by Health Care Professionals (HCPs; e.g., physicians, pharmacists) and non-H...
Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis
Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis
Prior molecular modelling analysis identified several medicines as potential inhibitors of glutathione peroxidase 1 (GPx1)...
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations
Over the past 2 years, several drugs have been approved for coronavirus disease 2019 (COVID-19) treatment, but their safet...
Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols
Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols
The number of reports on suspected drug-induced memory impairment submitted to the US Food and Drug Administration increas...
Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 2023
Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 2023
Appendix: Speaker BiographiesTobias Dreischulte, MPharm, MSc, PhD, is Professor of Clinical Health Services Research at th...
Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France
Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France
In 2021, the massive Covid-19 vaccination campaign in France was accompanied by an intensified pharmacovigilance monitorin...
Pulmonary Toxicity Associated with Immune Checkpoint Inhibitors-Based Therapy: Current Perspectives and Future Directions
Pulmonary Toxicity Associated with Immune Checkpoint Inhibitors-Based Therapy: Current Perspectives and Future Directions
Immune checkpoint inhibitors (ICIs) have shown efficacy in tumor therapy. However, the risk of pulmonary toxicity from ICI...
Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance
Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance
As part of routine safety surveillance, thousands of articles of potential interest are manually triaged for review by saf...
The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance)
The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance)
Funding Not applicable. Con...
Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK’s Training and Mentoring Pilot Project in the Abidjan Region
Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK’s Training and Mentoring Pilot Project in the Abidjan Region
Pharmacovigilance (PV) in sub-Saharan Africa relies on passive surveillance but underreporting of adverse events (AEs) by ...
Intravenous Medication Administration Safety with Smart Infusion Pumps in the Neonatal Intensive Care Unit: An Observational Study
Intravenous Medication Administration Safety with Smart Infusion Pumps in the Neonatal Intensive Care Unit: An Observational Study
Infants in the neonatal intensive care unit (NICU) are among the most vulnerable patient populations and medication errors...
Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch
Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch
Biosimilars are additional treatment options that are approved based on robust analytical and clinical comparisons with th...
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
The benefit/risk profiles of biologics can be affected by comorbidities, certain demographic characteristics, and concomit...
Drug Utilisation Patterns of Alternatives to Ranitidine-Containing Medicines in Patients Treated with Ranitidine: A Network Analysis of Data from Six European National Databases
Drug Utilisation Patterns of Alternatives to Ranitidine-Containing Medicines in Patients Treated with Ranitidine: A Network Analysis of Data from Six European National Databases
Ranitidine, a histamine H2-receptor antagonist (H2RA), is indicated in the management of gastric acid-related disorders. I...
Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults
Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults
Polypharmacy is common and is associated with higher risk of adverse drug event (ADE) among older adults. Knowledge on the...
The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands
The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands
The annual reformulation of the seasonal influenza vaccine results in fluctuating frequencies and severity of adverse effe...
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