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Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance.

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Title: Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance.
Authors: Crisafulli S; Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37124, Verona, Italy., Bate A; Global Safety, GSK, Brentford, UK.; Department of Non-Communicable Epidemiology, London School of Hygiene and Tropical Medicine, London, UK., Brown JS; TriNetX, Cambridge, MA, USA.; Department of Population Medicine, Harvard Medical School, Boston, MA, USA., Candore G; Medical Affairs and Pharmacovigilance, Bayer AG, Berlin, Germany., Chandler RE; Coalition for Epidemic Preparedness Innovations, Oslo, Norway., Hammad TA; Takeda Development Center Americas, Inc., Cambridge, MA, USA., Lane S; Drug Safety Research Unit, Southampton, UK.; University of Portsmouth, Portsmouth, UK., Maro JC; Department of Population Medicine, Harvard Medical School, Boston, MA, USA., Norén GN; Uppsala Monitoring Centre, Uppsala, Sweden., Pariente A; Université de Bordeaux, INSERM, BPH, Team AHeaD, U1219, 33000, Bordeaux, France.; Service de Pharmacologie Médicale, CHU de Bordeaux, INSERM, U1219, 33000, Bordeaux, France., Russom M; National Medicines and Food Administration, Ministry of Health, Asmara, Eritrea.; Department of Medical Informatics, Erasmus Medical Center, Rotterdam, The Netherlands., Salas M; Bayer Pharmaceuticals Inc., Whippany, NJ, USA.; University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA., Segec A; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands., Shakir S; Drug Safety Research Unit, Southampton, UK.; University of Portsmouth, Portsmouth, UK., Spini A; Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37124, Verona, Italy., Toh S; Department of Population Medicine, Harvard Medical School, Boston, MA, USA., Tuccori M; Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37124, Verona, Italy., van Puijenbroek E; Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.; PharmacoTherapy, Epidemiology and Economics, University of Groningen, Groningen Research Institute of Pharmacy, Groningen, The Netherlands., Trifirò G; Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro 10, 37124, Verona, Italy. gianluca.trifiro@univr.it.
Corporate Authors: Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance
Source: Drug safety [Drug Saf] 2025 Sep; Vol. 48 (9), pp. 959-976. Date of Electronic Publication: 2025 Apr 13.
Publication Type: Journal Article; Consensus Statement
Journal Info: Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9002928 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1942 (Electronic) Linking ISSN: 01145916 NLM ISO Abbreviation: Drug Saf Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="JN" term="%229002928%22">Drug safety</searchLink> [Drug Saf] 2025 Sep; Vol. 48 (9), pp. 959-976. <i>Date of Electronic Publication: </i>2025 Apr 13.
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