This think tank is hosted by the Cardiac Safety and Education Collaborative (CSEC)—a partnership between the Cardiac Safety Research Consortium (CSRC) and DIA.

Postmarketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Potential limitations of these data sources include potential underreporting, lack of geographic diversity, potential of patients’ perspectives being filtered through health care professionals and regulatory agencies, and time lag between event occurrence and discovery.

There is growing interest by safety stakeholders in exploring the use of social media (“social listening”) to supplement established approaches for pharmacovigilance. Health information posted online by patients is often publicly available, and thus represents an untapped source of postmarketing safety data that could supplement data from existing sources of cardiac safety information. The purpose of this think tank is to explore current methods of collecting and evaluating social listening data. Representatives from industry, academia, and the FDA will share their perspectives on the topic of social listening and discuss its potential implications in the field of cardiac safety.

This think tank is hosted by the Cardiac Safety Education Collaborative (CSEC)—a partnership between DIA and the Cardiac Safety Research Consortium (CSRC), an FDA and Duke University public-private partnership. The objective of the CSEC is to advance open dialogue of issues related to cardiac safety that represent barriers to medical product development, or issues that constitute limitations in current regulatory science. This think tank is part of the CSEC Signature Program that will span the course of a year and includes a webinar and various publications.

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