Events
Duane Morris Partner Frederick Ball to Present on "Hot Topics in Food, Medical Devices and Pharmaceuticals"
September 10, 2012 | São Paulo, Brazil
Duane Morris partner Frederick Ball will be discussing
"Hot Topics in Food, Medical Devices and Pharmaceuticals" at the Food and Drug Law Institute's (FDLI) U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation conference, on Monday, September 10, 2012, in São Paulo, Brazil.
Brazil is rapidly emerging as a world leader in innovation and development in the pharmaceutical, medical device and food industries. Stakeholders ranging from multinational companies to small startups are staking a foothold in the region. The U.S. Food and Drug Administration (FDA) and the Brazilian National Health Surveillance Agency (ANVISA) are working together to safeguard the integrity of the products being exchanged between the two countries and by extension across the globe.
Understanding the current legal, regulatory and economic environment for the development and sale of pharmaceuticals, medical devices and food in both countries is imperative for anyone doing business, or working with clients who are doing business, between the two countries. The Food and Drug Law Institute's two-day conference is where government officials and internationally renowned specialists will come together to discuss pharmaceutical, medical device, and food law, regulation, and policy in the U.S. and Brazil. The conference will focus on business opportunities and policy challenges of producing safe products and promoting public health.
In this afternoon break-out session, speakers will address recent developments in the areas of food, medical devices and pharmaceuticals. These include the FDA's Food Safety Modernization Act (FSMA), which changes the rules for food imports. Recent Brazilian and U.S. approval initiatives for medical devices include significant regulatory changes, particularly in Brazil. The panel will explore advanced clinical trial planning and timelines in Brazil; navigating and planning for GMP inspection requirements in both countries; securing and maintaining adequate reimbursement for innovative medical devices; and improving communication between sponsors and investors. Discussion will also include registration and inspections in both the U.S. and Brazil, which continue to grow increasingly complex.
To learn more about the conference, or to register, please visit the FDLI's website.
