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The eighth revision of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology was published on the ENCePP website.

ENCePP is a network coordinated by the European Medicines Agency (EMA), involved in research, in pharmacoepidemiology and pharmacovigilance. Annalisa Landi, also representing Teddy European Network of Excellence for Paediatric Research and its Health Data Working Group and other FGB researchers, are actively committed in ENCEPP activities with special reference to the Inventory of EU data sources and methodological approaches for multi-source studies.

The latest revision of the Guide highlights the importance of the Guide for pharmacoepidemiologic studies to be conducted in the context of the COVID-19 pandemic.

The rapid progression of the COVID-19 pandemic has generated several hypotheses on the safety and effectiveness of therapeutic interventions, such as repurposed medicines. The need for quick answers triggered the initiation of observational studies carried-out with fast data collection, analysis and reporting. In a pandemic situation, the same methodological standards as those applied in any other circumstance should nevertheless be used to provide valid and reliable evidence supporting rapid treatment decisions by clinicians and regulators. Adherence to existing guidance on the appropriate design and conduct of pharmacoepidemiologic studies has therefore huge importance.

The Guide aims to offer a dynamic and publicly available resource for methodological guidance in pharmacoepidemiology in terms of study design, data collection, statistical analysis as well as data protection and ethical aspects, providing recommendations on the practical implementation of pharmacoepidemiological principles and innovative methods. It includes links to selected published articles and guidelines that illustrate important principles of pharmacoepidemiological research.

The Guide is updated annually by structured review to maintain its dynamic nature. For this purpose, any comment and additional relevant guidance document may be forwarded to ENCePP_Secretariat@ema.europa.eu.

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