Latin America Pharmacovigilance and Risk Management Strategies Workshop

Both regulators and sponsors are increasingly using structured frameworks to assess the benefit-risk profile of medicinal products. Such frameworks can accommodate a variety of data sources including databases from health authorities, companies, WHO, patient clinical records, national, and international disease records, social media among others. Real world data and social media have become sources of pharmacovigilance information that can possibly change the path of safety surveillance. This session will provide information about these two sources of pharmacovigilance information and provide critical analysis on how they can produce valuable contributions for patient safety. The audience will learn how to plan safety monitoring programs in the pre- and post-market phase to support the implementation of valuable data collection. This session will review the key considerations in evaluating the impact of uncertainty on the quality of the data, heterogeneity of real world evidence, and the impacts (or value of this data) on benefit-risk assessment decision and signal detection.