Social media is making an impact in our lives and it looks like it is here to stay. In the medical device industry, social media appears to be having an impact in areas of advertising, promotion and potentially could have an impact in adverse event reporting. We have only recently seen some information from FDA regarding their initial perspectives on the use of electronic social media as it relates to off-label promotion. In light of the limited guidance, what are best practices for medical device companies when considering the role of social media? What are other common pitfalls and concerns that companies of any kind face—including medical device companies—with regard to social media? This panel will provide opportunity to discuss:

• The role of social media policies within a medical device company
• Activities in social media related to advertising, promotion, complaints and compliance
• The impact of FDA's recent Draft Guidance for Industry on "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices"
• Actions related to solicited and unsolicited requests for information via social media
• How to consider participation and responses in public forums
• What to consider when handling adverse events reported via social media
• Best practices for keeping your messaging balanced and in compliance
• Concerns for increased liability with actions taken (or not) in social media
• Best practices for addressing other common pitfalls companies encounter in social media

Vanessa Costa
Manager, Corporate Compliance & Business Practices, Endo Health Solutions

Ms. Costa is a Manager within Endo’s Corporate Compliance & Business Practices Department. She has overall responsibility for the Urology, Endocrinology and Oncology corporate compliance programs and external reporting.  

Nicole D. Galli
Partner, Benesch Friedlander Coplan & Aronoff LLP

Ms. Galli is a partner with the firm's Intellectual Property Practice Group. She focuses her practice on complex commercial litigation, including intellectual property litigation, and intellectual property counseling. Ms. Galli regularly counsels clients in the emerging area of social media, where the issues that arise can overlap a number legal disciplines, as well as raise entirely new issues not yet addressed by existing law.  

Yarmela Pavlovic
Partner, Hogan Lovells US LLP

Ms. Pavlovic's practice focuses primarily on the U.S. Food and Drug Administration (FDA)'s regulation of medical devices. Her experience includes counseling of medical device companies in relation to the advertising and promotion of medical devices.

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This seminar is sponsored by Exponent, Inc., Saul Ewing, LLP, and UCKIZ