"Online monitoring...is effective, appropriate and fully compliant with regulated reporting requirements for the health industry."
Saint Louis, MO (PRWEB) April 30, 2010
v-Fluence Interactive president Jay Byrne provides commentary on the importance of online monitoring which is effective, appropriate and fully compliant with regulated reporting requirements for the health industry. Excerpts include:
In April of 2002 I was interviewed by Wired Magazine for a report entitled “Why are drug firms silent online?” At that time many pharmaceutical companies had policies limiting or outright banning their official monitoring of the Web, especially the fast growing blogosphere and emerging uncharted realm of consumer generated social media. The reason? Lack of regulatory clarity, particularly regarding the issue of adverse event reporting requirements for content found when formally tracking this vast space.
Starting in 2001, our firm began developing systems and approaches to Internet monitoring which helped to ensure regulatory reporting compliance with comprehensive tracking of Web content; this content included blogs, social media and other potentially influential dialogue spaces. We dedicated analysts and senior counselors to specific therapeutic areas like mental health, respiratory illness and cardiovascular disease. Our team members received annual training in U.S. Food and Drug Administration (FDA) adverse event reporting, off label promotions and other regulatory requirements and industry policy issues.
Today, we help our clients digest the vast volume of consumer generated media and other online content with smart systems and smart people. Our company seeks to identify relevant and influential content, then organize and report these items in a manner which can be effectively and responsibly used by senior industry brand strategists, issues and policy managers. These clients include major pharmaceutical brands, patient advocacy groups and professional trade associations. They use our information with confidence that they are in full compliance for reporting adverse events and addressing other related regulatory issues.
Last November we testified at the FDA hearing on promotion of regulated medical products using the Internet and social media tools. Reflecting on our ten years of experience monitoring online environments for specific therapeutic areas and the pharmaceutical industry as a whole, we cautioned on the challenges of effective and responsible online monitoring and corresponding regulatory reporting requirements.
To read the full post visit: http://www.v-fluence.com/blog/461/online-monitoring-and-the-pharmaceutical-industry