Guideline proposal for pharma companies to manage pharmacovigilance activities in digital media


  • Daniela Bernardini Novartis Farma, Origgio (VA) - Italy
  • Ilenia Bocchi Bayer, Milan - Italy
  • Stefano Bonato Bayer, Milan - Italy
  • Davide Bottalico Takeda Italia, Rome - Italy
  • Valentina Calderazzo Boehringer Ingelheim Italia, Milan - Italy
  • Carmela Casino Servier Italia, Rome - Italy
  • Gian Nicola Castiglione Chiesi Farmaceutici, Parma - Italy
  • Carla Cottone Teva Italia, Assago (MI) - Italy
  • Stefania Dellon Neopharmamed Gentili, Milan - Italy
  • Ilaria Grisoni Jazz Pharmaceuticals, Villa Guardia (CO) - Italy
  • Amanda Mattavelli Janssen-Cilag, Cologno Monzese (MI) - Italy
  • Giacomo Pirisino Astellas Pharma, Milan - Italy
  • Silvia Romano Sanofi Pasteur Vaccines Italy and Malta, Milan - Italy
  • Grazia Sirizzotti Biogen Italia, Milan - Italy
  • Lisa Stagi Roche, Monza (MB) - Italy
  • on behalf of the SIMeF Working Group



Adverse events, Artificial intelligence, Digital activities, Pharmacovigilance, Social media


Internet has become a central part of our everyday lives. Digital media are integrated in our daily routines and play a critical role in the dissemination of public health information and disease prevention guidelines. For this reason, digital activities are becoming more and more impacting in pharma company activities and this is an increasing trend after the pandemic period. Managing digital activities from pharmacovigilance (PV) perspective may have challenges linked to correct assessment of the activities and application of PV rules: this was underlined in recent publications, where the need to have more specific guidelines linked to digital activities management was evidenced.

Considering this scenario and the continuous evolution of the digital activities, the SIMEF PV working group decided to work on a proposal guideline to provide support to PV departments in pharma companies, suggesting a framework to manage sponsored digital activities (i.e., website, web apps, social media webpage, chatbots) impacting potential collection of adverse events (AEs). The purpose of this guideline is to provide useful instructions on how to manage PV requirements for digital activities, suggesting potential solutions for assessing initiatives, creating governance framework, conducting a correct vendor management, and suggesting practical approaches for AEs reporting and follow-up. The aim of this document is also to trigger a broader discussion among relevant stakeholders on which PV guidelines may be useful and appropriate considering this continuous evolving scenario.



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How to Cite

Bernardini, D., Bocchi, I., Bonato, S., Bottalico, D., Calderazzo, V., Casino, C., Castiglione, G. N., Cottone, C., Dellon, S., Grisoni, I., Mattavelli, A., Pirisino, G., Romano, S., Sirizzotti, G., Stagi, L., & SIMeF Working Group, on behalf of the . (2022). Guideline proposal for pharma companies to manage pharmacovigilance activities in digital media. AboutOpen, 9(1), 21–28.



Point of view


Received 2022-03-21
Accepted 2022-04-04
Published 2022-04-21