Head of Pharmacovigilance, Italy
Social media is part of everyday life, and pharmaceutical companies are also moving more and more in this direction. Like all corporate business projects, social media must also meet the requirements to comply with pharmacovigilance obligations. We will see how they can be managed from a pharmacovigilance point of view.
An analysis of follow-up attempts for adverse event reports was conducted to describe the characteristics of a risk-based follow-up for Individual Case Safety Reports (ICSR)
While our product portfolios continue to add combination products in the mix, leading to increasing complexity throughout the PV process there needs to be a deeper understanding of the device aspect including malfunctions and unique safety related requirements. The risk management process mow needs to incorporate the device related risk and more.
During the pandemic, there was a requirement to apply WHO-UMC causality criteria on a case level for safety evaluations. This criterion has limitations when used for vaccines due to the lack of possibility of rechallenge/dechallenge and withdrawal for vaccines, leaving some room for individual interpretation when applying the criteria. To overcome this challenge, a supporting algorithm was developed to ensure consistent causality assessment when volumes are high, and many people are reviewing cases.