Dr. Jeffery Shuren, director of CDRH will be the plenary speaker at AdvaMed 2011: The MedTech Conference on September 28. Conference highlights include a series of  “CEO Unplugged” sessions, a biodiagnostics primer, executive workshops, company presentations, and medtech partnering meetings. President George W. Bush and Indiana Governor Mitch Daniels have already been tapped to speak.

Shuren, who has been with FDA since 1998, took on his current role in 2008, managing the staff responsible for assuring the safety, effectiveness and quality of medical devices.  He has played a key role in several policy initiatives, including the reauthorization of the Medical Device User Fee Act, and the creation of The Sentinel Initiative, which works toward establishing a national electronic system to monitor medical product safety. He has also participated in the development of the FDA’s Pandemic Influenza Preparedness Strategy, the Counterfeit Drug Task Force Report, and the interagency Food Safety Working Report to the President of the United States. 

AdvaMed 2011 will feature 39 educational panels. Once again, the Business Development Track will unveil the annual “Pulse of the Industry” report by Ernst & Young, accompanied by a CEO panel discussion, while the Emerging Growth Company Track will provide perspectives on the state of medical device and diagnostics funding from the angel, venture capital and private equity community.  The InVitro Track will cover topics such as personalized medicine and the future of the IVD directive, as well as the alignment of medtech incentives through value-based insurance design.

The Key Health Policies Track will enable attendees to learn the ins and outs of selling to the UK’s National Health Service, as well as how to bring medical devices to the US market. Those attending the Legal Track will gain insights into the Patent Reform Act of 2011 and new and impeding medical device excise taxes. The Quality Track will feature ways to negotiate medical product outsourcing agreements and quality system strategic planning, while the Reimbursement Track will focus on the impact of US CMS ACO regulations. The Technology and Regulatory Affairs Track will focus on crafting a useful UDI system, US and EU regulatory systems and the impact of the FDA’s 510(k), and challenges and solution to the pre-IDE/IDE process.

In total, nearly 120 industry experts and thought leaders will participate in these stakeholder- focused educational panels. In addition to these educational panels there are a series of networking and business development opportunities throughout the conference. To learn more about the conference program, keynote speakers or schedule, visit www.AdvaMed2011.com or call 202-434-7213. Discounted rates are available for those who register by the August 5 early deadline.