ReviewDrug safety2018
Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action.
Review in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators.Therapeutic innovation & regulatory science · 2022Pooled it
- Trends in adverse drug reaction reporting in eight selected countries after the implementation of new pharmacovigilance regulation in 2012: a joinpoint regression analysis.European journal of clinical pharmacology · 2025Article
- Pharmacovigilance - Technological Advancements, Recent Developments and Innovations.Current drug safety · 2025Review
- Building functional and sustainable pharmacovigilance systems: an analysis of pharmacovigilance development across high-, middle- and low-income countries.Therapeutic advances in drug safety · 2025Article
- Global trends in pharmacovigilance-related events: a 30-year analysis from the 2019 global burden of disease study.International journal of clinical pharmacy · 2024Article
- The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System.Drug safety · 2024Review
- Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST.JMIR medical informatics · 2024Article
- Review
- Adverse drug reaction reporting for more than a decade: The need for pharmacovigilance policy implementation in Turkey.Journal of Taibah University Medical Sciences · 2022Article
- Article
- Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use.Pharmacoepidemiology and drug safety · 2020Review
- Medication Risk Management.Innovations in pharmacy · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 6 institutions in 6 countries.
Funding
Abstract
In November 2013, a team of European regulators initiated the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Funded by the Health Programme of the European Union, and with contributions from the involved Member States, SCOPE gathered information and expertise on how regulators in Member States run their national pharmacovigilance systems to meet the requirements of the pharmacovigilance legislation that came into effect in June 2012. The SCOPE project evaluated then-current practices and developed tools to further improve the skills and capability in the pharmacovigilance network. The project was divided into eight separate work streams, five of which concentrated on pharmacovigilance topics-collecting information on suspected adverse drug reactions, identifying and managing safety issues (signals), communicating risk and assessing risk minimisation measures, supported by effective quality management systems. The other three work streams focused on the functional aspects-coordination, communication and evaluation of the project. Through the project, SCOPE delivered guidance, training in key aspects of pharmacovigilance, and tools and templates to support best practice. The deliverables provide practical guidance that those working in the European national competent authorities can take to strengthen their national systems. The SCOPE outputs can be useful for other stakeholders involved in pharmacovigilance activities, including the pharmaceutical industry, healthcare professionals, patient and consumer organisations, and academia.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.