Regulatory Definitions and Good Pharmacovigilance Practices in Social Media: Challenges and Recommendations

Social media presents new challenges to the biopharmaceutical industry for conducting pharmacovigilance activities. The authors reviewed worldwide regulatory guidance documents related to monitoring of adverse events posted on social media sites and identified gaps in current regulatory definitions for pharmacovigilance. Points to consider for addressing these gaps are made to offer standards for industry consideration and a potential framework for guidance from global health authorities.

Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Naik, P., Umrath, T., van Stekelenborg, J., Ruben, R., Abdul-Karim, N., Boland, R., Ibara, M., Ekuta, J., Washburn, D., Stergiopoulos, S. Tags: Regulatory Science Source Type: research