FDA and global health authorities mandate that adverse events be reported and collected; however, research estimates that 90% of these reports worldwide are not reported. They are out there though, in online forum postings, social media conversations, and in specialized web communities. The challenge has been to extract meaningful PV data from all the online noise. Some companies are hesitant because regulations have not been developed to set the parameters of what is acceptable and what can be ignored.
Other companies have risen to be the leaders but lack the tools necessary to enable a good search. We will discuss what approaches are optimal and how to address the challenges of fulfilling pharmacovigilance and safety surveillance with big data.