ABSTRACT
Introduction: Digital media are integrated in our daily routine, play a critical role in the dissemination of health information and disease prevention guidelines and are becoming more impacting in pharma-companies activities, with an increasing trend after the pandemic period. They pose pharmacovigilance challenges for application of PV rules. a structured approach is needed for pharmacovigilance departments in the new digital scenario. Objective: The SIMeF pharmacovigilance working group worked on digital topic since two years, addressing it in a structured way: from a a specific survey (1), to proposals for addressing the needs underlined, to seminars and events for capability building and discussions among experts. SIMEF group also worked on a proposal guideline for sup-porting PV departments (6), suggesting a framework for managing sponsored digital activities with potential collection of adverse events, to provide useful operative suggestions on PV requirements management. Methods: A research on the regulation in force and the current status of digital media was conducted, with a focus on pharmacovigilance, privacy and quality aspects. The guideline was written considering the expertise of the authors in the management of pharmacovigilance activities. Seminars were done to favour discussions among experts. Results: All healthcare sectors are impacted by digital media: scientific societies, academic institutions, patients' associations, hospitals and healthcare institutions are increasing their online presence 2,3. Social media are used by patients to compare health data, collect treatment information and discuss with physicians, with an increasing active role. Digital media should be considered as a potential source of AEs by pharmacompanies, when managing sponsored activities. PV aspects of digital activities are currently described, although not in details, in different regulations by EMA, FDA and MHRA. Management digital projects by pharmacompanies is complex and require a structured multifunctional process, to guarantee a holistic approach to regulatory and legal requirements. Many aspects should be considered for compliance and efficiency. SIMeF work pose considerations on the importance of crossfunctional work, early pharmacovigilance advice, tracking system, execution of risk-based assessment, escalation to quality, SOPs presence, personnel trainings (including vendors) and a Quality System covering PV. New skills and capability will be crucial for PV departments in future. Conclusion: Digital media are powerful instrument to increase patients and physicians involvement and to support disease knowledge. The rising amount of safety data generated through digital opens a challenge for pharmacompanies. This work is a starting point to trigger broader discussions around PV quality system for digital activities.