Overview: Medical Device Compliance Panel: Practical Approaches to Handling Real-life (and Sometimes Tricky) Compliance Issues
A scenario-based discussion on issues related to company relationships with and payments to doctors, off-label promotion, sales/ account representative activities and more. Together, we will explore these common (and sometimes difficult) risk areas that impact medical device companies and provide practical ways to manage such issues and mitigate business and legal risks. Audience participation encouraged..
Michelle D. Axelrod, Principal, Porzio, Bromberg & Newman, PC and Vice President, Porzio Life Sciences, LLC
Daniel Char, Associate General Counsel – Commercial, Smith & Nephew
John Blumers, Vice President & Division General Counsel, Biomet
Tracy Berns, Vice President, Chief Compliance & Regulatory Counsel, Covidien
Patrick Mooty, Director, Corporate Compliance, Heartware
About our sponsor: Porzio Life Sciences, a wholly owned subsidiary of the law firm Porzio, Bromberg & Newman, provides healthcare compliance products and services to medical device, biotechnology and pharmaceutical companies. Porzio Life Sciences consults on a wide range of compliance matters including policy and procedure development and implementation, regulatory review, training, state distribution licensing and assistance with sample/ trial use programs. PorzioLS performs gap assessments, and provides auditing and monitoring services. A Porzio Life Sciences technical solution, Porzio AggregateSpendID SM, manages clients’ reporting requirements under federal and state Sunshine Acts. Subscriptions to PorzioLS databases offer the latest healthcare industry information regarding federal and state regulations, and enforcement actions. Porzio Life Sciences’ offices are located in Massachusetts, New Jersey and New York; Porzio Life Sciences’ customers are located throughout the United States.