Optimising Real-World Evidence Studies for Regulatory Decision-Making and Impact Assessment in PharmacovigilanceRunning title: Optimising RWE for Regulatory DecisionsIgnatios Ioakeim-Skoufa 1,2,3,4,5,6, Miguel Ángel Hernández Rodríguez4,7,*1Department of Drug Statistics, Division of Health Data and Digitalisation, Norwegian Institute of Public Health,2Emerging Technologies Advisory Group, ISACA,3EpiChron Research Group on Chronic Diseases, Aragon Health Sciences Institute (IACS), Aragon Health Research Institute (IIS Aragón), ,4Drug Utilisation Work Group, Spanish Society of Family and Community Medicine (semFYC),5Research Network on Chronicity, Primary Care, and Health Promotion (RICAPPS), of Carlos III (ISCIII),6Department of Pharmacology, Physiology, and Legal and Forensic Medicine, Faculty of Medicine, of ,7Support and Planning Unit, Directorate of the Canary Islands Health Service,*Corresponding author: Miguel Ángel Hernández Rodríguez, [email protected] Ioakeim-Skoufa: https://orcid.org/0000-0002-6518-749XMiguel Angel Hernández Rodríguez: https://orcid.org/0000-0001-7545-8057This manuscript is an original study, has not been published elsewhere, nor prior postings/presentations, and is not currently under consideration by another journal. All authors contributed significantly to this work and have read and approved the final version submitted.Additionally, to our knowledge, the named authors have no conflict of interest, financial or otherwise.This research received no external funding.Ethical approval and Informed Consent Statement: Not applicable.Acknowledgements: The authors would like to extend their gratitude to Dr. Kerry Atkins (Health Technology Assessment Policy Branch, Australian Government Department of Health) for his invaluable insights and support.