Research map: Implementation Science for Effective Risk Management of Medicines: A Call for Global Action
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Papers in this map
Standards for Reporting Implementation Studies (StaRI) Statement
· Hilary Pinnock · 2017 · 1561 citations · Cited by this paper
Perspective on Better Access to Data and Data Integration in Pharmacovigilance: Information from a Focus Group
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A Large Language Model for Extracting Post-marketing Adverse Drug Events from Clinical Notes in the Electronic Health Record
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Novel approaches for vaccine development
· Makda S. Gebre · 2021 · 358 citations · Cited by this paper
Pharmacovigilance Through Fresh Eyes: The International Society of Pharmacovigilance Student Community's Role in Shaping the Future of Pharmacovigilance
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Pharmacovigilance in low‐ and middle‐income countries: A review with particular focus on Africa
· Ronald Kiguba · 2021 · 138 citations · Cited by this paper
Reliability of Self-Reported Maternal Health and Mother–Infant Outcome Data in Web-Based Questionnaires
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Therapeutic Advances in Multiple Sclerosis
· Jennifer H. Yang · 2022 · 134 citations · Cited by this paper
Liver Safety of the Dual Neurokinin-1/-3 Receptor Antagonist Elinzanetant
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Emerging Genetic Therapy for Sickle Cell Disease
· Stuart H. Orkin · 2018 · 121 citations · Cited by this paper
MCSG: A Method for Simultaneous Disproportionality Analysis and Background Rate Estimation in Large Pharmacovigilance Databases
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The Race for Global Equitable Access to COVID-19 Vaccines
· Lukman Nul Hakim Md Khairi · 2022 · 79 citations · Cited by this paper
Pharmacovigilance Due Diligence in Drug Development: A Practical Playbook for Risk Identification, Compliance Assessment, and Strategic Decision Making
· 2025 · Related
A review of studies evaluating the effectiveness of risk minimisation measures in Europe using the European Union electronic Register of Post‐Authorization Studies
· Pareen Vora · 2018 · 47 citations · Cited by this paper
US Risk Evaluation and Mitigation Strategies with Elements to Assure Safe Use: A Longitudinal Analysis of REMS Modifications (2008–2022)
· 2026 · Related
The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal Products
· Meredith Y. Smith · 2017 · 37 citations · Cited by this paper
GP Consultations for Herpes Zoster After COVID-19 Vaccination: A Self-Controlled Cohort Study Based on Electronic Health Record Data from the Netherlands
· 2025 · Related
Are risk minimization measures for approved drugs in Europe effective? A systematic review
· Esther Artime · 2019 · 36 citations · Cited by this paper
Benefit–Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist
· Christine Radawski · 2015 · 28 citations · Cited by this paper
Risk Management for the 21st Century: Current Status and Future Needs
· Rania Mouchantaf · 2021 · 26 citations · Cited by this paper
Where Is the Implementation Science? An Opportunity to Apply Principles During the COVID-19 Pandemic
· Stephanie Parks Taylor · 2020 · 22 citations · Cited by this paper
Review of Studies Evaluating Effectiveness of Risk Minimization Measures Assessed by the European Medicines Agency Between 2016 and 2021
· Renske J. Grupstra · 2023 · 20 citations · Cited by this paper
Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review
· Andrea M. Russell · 2020 · 17 citations · Cited by this paper
Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018)
· Linda My Huynh · 2021 · 17 citations · Cited by this paper
Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014–2018) Using RE-AIM
· Gita A. Toyserkani · 2020 · 15 citations · Cited by this paper
The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)
· Meredith Y. Smith · 2024 · 12 citations · Cited by this paper
Pharmacovigilance processes in low- and middle-income countries: moving from data collection to data analysis and interpretation
· Olga Menang · 2025 · 8 citations · Cited by this paper
Development of a multicomponent implementation strategy to reduce upper gastrointestinal bleeding risk in patients using warfarin and antiplatelet therapy, and protocol for a pragmatic multilevel randomized factorial pilot implementation trial
· Jacob E. Kurlander · 2022 · 8 citations · Cited by this paper
Personalized medicine to implementation science: Thiopurines set for the leap
· Vishal Sharma · 2022 · 8 citations · Cited by this paper
The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System
· Priya Bahri · 2024 · 7 citations · Cited by this paper
Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study
· Mathias Møllebæk · 2024 · 6 citations · Cited by this paper
Risk Minimisation Evaluation with Process Indicators and Behavioural or Health Outcomes in Europe: Systematic Review
· Esther Artime · 2020 · 5 citations · Cited by this paper
Promoting safe and appropriate use of miltefosine to treat tegumentary leishmaniasis in Brazil: a best practice implementation project
· Sarah Nascimento Silva · 2024 · 4 citations · Cited by this paper
Using Mixed Methods to Evaluate Risk Minimisation Programs in Europe and the USA: An Innovative Blueprint
· Meredith Y. Smith · 2025 · 4 citations · Cited by this paper
REMS Logic Model: A Pragmatic Framework for Incorporating Drug Safety into Clinical Practice
· Gita A. Toyserkani · 2025 · 3 citations · Cited by this paper
Advances in Drug Safety: Highlights from the 23rd Annual Meeting of the International Society of Pharmacovigilance
· Omar Aimer · 2024 · 1 citation · Cited by this paper
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