TQ 6.1: When should drug companies report adverse events submitted via the Internet? Should a drug company pursue an adverse event reporter if it doesn’t have all of the required information?
TQ 6.2: According to the Tufts study, what are drug companies’ key concerns with using social media? What aspects of clinical research are companies using social media for, if any?
TQ 6.3: According to the IMS report, what are some of the technical challenges that companies face in adopting an effective social media strategy? What do the Institute’s findings with respect to Wikipedia indicate for drug/device firms?
TQ 6.4: Although the FFIEC guidance does not apply specifically to drug and device companies, it is instructive. According to the guidance, what are the key elements of an effective risk management program? Which of the risks identified in the guidance may also apply in the drug/device arena?
DQ 6.1: Choose a social media platform owned/operated by a drug or device company (such as a Facebook or Wikipedia page) and describe how the company is using this platform right now. Does this use align with the FDA’s social media draft guidances? In your opinion could the company be doing more, or should it be doing less?
DQ 6.2: What other issues (aside from regulatory compliance) do you foresee arising if drug and device companies start engaging in more social media activity, such as recruitment for clinical trial participants, study design, and creating brand awareness?