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DA E G SID A N I EN

REGISTER ONLINE TODAY & SAVE www.fdli.org/brazil

U.S. & BRAZIL


Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation
September 1011, 2012 | So Paulo, Brazil

CONFERENCE SPONSORS
DIAMOND SPONSOR

GOLD SPONSORS

SILVER SPONSORS

BRONZE SPONSORS

ACADEMIC/NON-PROFIT SPONSOR

NETWORKING BREAKFAST SPONSOR

LUNCH SPONSOR

CONFERENCE TOTE SPONSOR

WHY ORGANIZATIONS ARE SPONSORING


Multinational companies are investing billions in emerging markets; domestic governments and international organizations are working together to establish laws and regulations to reflect this growing international industry. Sponsoring this conference provides an opportunity for your company to establish itself as a leader in the global food and drug law community. Learn more at www.fdli.org/brazil.
U.S. & Brazil Conference | Sept. 1011, 2012 | So Paulo, Brazil

SUMMARY, HIGHLIGHTS, WHOS ATTENDING U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device & Food Law & Regulation
September 1011, 2012 | So Paulo, Brazil
Brazil, the 6th largest economy in the world, is experiencing unprecedented growth and regulation in the pharmaceutical, medical device and food industries, dramatically affecting the operations of both multinational and Brazilian companies. If youre doing business or thinking of doing business in Brazil, you need to know the regulatory landscape. At this event, you will hear directly from top Food and Drug Administration (FDA) and National Health Surveillance Agency (ANVISA) officials, on-the-ground multinational and Brazilian manufacturer representatives, experienced attorneys, and recognized international trade and import experts on how U.S. and Brazilian legal, regulatory and policy changes are affecting your responsibilities. Join us for this landmark conference that will focus on business opportunities and policy challenges of successfully producing products for distribution in the U.S. and Brazil, dealing with legal and regulatory mandates, and promoting public health.

3 REASONS THIS IS A MUST-ATTEND EVENT


Regulators will discuss existing and emerging issues in law, regulation and trade between the U.S. and Brazil. A unique opportunity to learn from and network with professionals with similar business and professional interests. Representatives from multinational and Brazilian companies will share success stories and lessons learned from doing business in Brazil.

WHO WILL ATTEND


Food and Drug Attorneys Government Officials Academics Food and Drug Industry Consultants Venture Capitalists and Investment Brokers Regulatory Affairs Professionals Government Affairs Professionals Safety Officers Compliance Officers Legal Counsel Business Development Professionals Global Strategy Professionals Corporate Planning Professionals Register Online: www.fdli.org/brazil

SCHEDULE AT-A-GLANCE
The conference website is being updated daily, visit www.fdli.org/brazil for the most up-to-date agenda and information.

Day 1 September 10th


7:308:30 am Registration and Networking Breakfast 8:3010:00 am Opening Keynote Address Food and Drug Law in Brazil & the United States: Strategic Overview and Look Ahead 10:30 am12:00 pm General Session Doing Business in Brazil: Pathways to Success, Innovation and Access 12:001:30 pm Networking Lunch and Case Study How to Develop Products for the Brazilian Consumer: Two Success Stories 1:303:00 pm Break-Out Sessions Food, Pharmaceutical, Medical Device 3:154:45 pm Break-Out Sessions Food, Pharmaceutical, Medical Device 5:005:30 pm Keynote Address 5:306:30 pm Cocktail Reception

Day 2 September 11th


7:308:30 am Attorney MeetandGreet Breakfast 8:4510:15 am General Session Influence of Trade Associations in the International Marketplace 10:45 am12:15 pm General Session Risks and Advantages of Global Supply Chain Management 12:152:00 pm Lunch Address Spotlight on Brazil: The World Cup 2014 and the Olympics 2016. Is Your Brand Ready? 2:003:15 pm Break-Out Sessions Food, Pharmaceutical, Medical Device 3:305:00 pm General Session What You Really Need to Know about Importing into the U.S. and Brazil 5:005:30 pm Closing Keynote Address U.S., Brazilian and Latin American Cooperation in Food, Drug and Device Regulation: The FDA Regional Director Perspective

KEYNOTE ADDRESSES
Food and Drug Law in Brazil and the United States: Strategic Overview and Look Ahead Top officials of the Brazilian National Health Vigilance Agency (ANVISA) and the U.S. Food and Drug Administration (FDA) will discuss significant developments in the regulation of the pharmaceutical, medical device and food industries. Brazil & Latin America: The Regulatory View from the FDA Latin America Country Director Michael Rogers, FDA Latin America Country Director, will provide his unique perspective, as the agencys top representative on the ground.
U.S. & Brazil Conference | Sept. 1011, 2012 | So Paulo, Brazil

FEATURED PANEL DISCUSSIONS


Doing Business in Brazil: Pathways to Success, Innovation and Access Leading decision-makers of multinational companies will discuss different models for success in Brazil. How to Develop Products for the Brazilian Consumer: Success Stories Top-level representatives from global medical products and food manufacturers will share insights into how to appeal to the unique nature of the Brazilian consumer. The Influence of Trade Associations in the International Marketplace During this roundtable discussion, executives of the leading trade associations representing Brazilian and multinational industry will discuss their role in promoting the medical device, pharmaceutical and food industries nationally and internationally, providing one of the most comprehensive trade associations forums ever held for these industries. International Supply Chain Management Panelists will discuss risks and advantages of supply chain management, including risk management strategies, tracking and traceability, information requirements and efficient supply chain lanes, and infrastructure challenges in the U.S. and Brazil. Importing into the United States and Brazil Panelists will discuss what you really need to know about importing food and medical products into the U.S. and Brazil: including key import admissibility issues, critical supply chain considerations, what to expect during inspection, and how to comply with complex documentation and labeling requirements.

INDUSTRY SPECIFIC BREAK-OUT SESSIONS


Food Topic Sessions
1. Defining Food in Brazil and the United States Learn how to communicate effectively with Brazilian and U.S. officials on food-related issues and how to navigate important jurisdictional distinctions and interactions between the various regulatory bodies in both countries. 2. The U.S. FDA Food Safety Modernization Act (FSMA): Changing the Rules for Food Imports Panelists will explain evolving import and accreditation requirements under FSMA. 3. The Tastes of the Brazilian Consumer Panelists will discuss the legal, regulatory and policy constraints of marketing and selling foods in Brazil and the U.S. (labeling requirements, additive permissibility, advertising restrictions, and compositional requirements).

Register Online: www.fdli.org/brazil

Medical Products Topic Sessions


1. Comparative Analysis of Regulatory Schemes Latest Rules for Approvals of Biosimilars, Complex Drugs and Bioequivalence Standards in Brazil and the U.S (Pharmaceutical and Biologics) Panelists will detail the latest rules for approvals of biosimilars, complex drugs and bioequivalence standards, including how to distinguish differences between the biosimilar and stand-alone approaches, data packages, clinical trial data access and confidentiality, and current and future harmonization efforts. Clinical Research in Brazil and the United States (Medical Device and Pharmaceutical) Panelists will analyze key issues in clinical research including areas of harmonization between U.S. and Brazilian regulation of clinical trials; important distinctions; how to navigate clinical research and the process for protocol approval and initiating trials; subject recruitment, enrollment and obtaining informed consent; and complying with the monitoring of trials and reporting responsibilities. 2. Whats on the 2012 and 2013 Front Burner? Latest Brazilian and U.S. Approval Initiatives (Medical Device) Panelists will explore regulatory changes affecting the launch of medical devices as well as navigating GMP inspection requirements essential for U.S. and Brazilian product approvals. Drug Registration and Inspections in the U.S. and Brazil (Pharmaceutical) Panelists will discuss the increasingly complex area of inspections and registration in the U.S. and Brazil. 3. Ensuring Consumer Protection: Best Practices Post Market Surveillance and Enforcement in Brazil and the U.S. (Medical Device and Pharmaceutical) Panelists will detail post market surveillance and enforcement including effective complaint handling system; complying with adverse event reporting requirements; dealing with the Brazilian Sentinel network; and current requirements for product recalls, market withdrawals and field action. Intellectual Property Issues and Developments (Pharmaceutical) Panelists will analyze intellectual property issues including: patents, trademarks, copyrights and data protection; patent term extension and the rise of patent litigation and legislation in the U.S.; review of patent applications in Brazil by ANVISA and Brazilian National Industrial Property Institute; biodiversity and genetic patrimony issues; and the connection between intellectual property, regulatory law and government initiatives in both countries.

SPECIAL NETWORKING EVENT


Attorney MeetandGreet Breakfast Sponsored by Peixoto e Cury Advogados Join us for breakfast to learn the nuts-and-bolts of practicing law in Brazil, including the regulatory requirements for foreign attorneys. Take advantage of this rare opportunity to network with local attorneys who are currently partnering with, or looking to partner with, international counsel and companies doing business in Brazil.
U.S. & Brazil Conference | Sept. 1011, 2012 | So Paulo, Brazil

FEATURED SPEAKERS
Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy, FDA Mark Paxton, Regulatory Counsel, CDER, FDA Michael Rogers, Director, Latin America Office, FDA Domenic J. Veneziano, Director, Division of Import Operations & Policy, Office of Regional Operations & CDR Public Health Service, FDA David Acheson, MD, Partner and Managing Director, Food and Import Safety, Leavitt Partners LLC Frederick R. Ball, Partner, Duane Morris LLP Gregory S. Barnett, Foreign Legal Consultant, Angelico Advogados

Additional government officials and speakers have been invited, and once confirmed, will be updated on www.fdli.org/brazil

William H. Bill Duffell, Sr. Vice President, Medtronic, Inc. Douglas B. Farquhar, Attorney, Hyman, Phelps & McNamara, P.C. Leslie Glick, Partner, Porter Wright Morris & Arthur LLP Albert T. Keyack, Consul for Intellectual Property Rights, Latin American Region, U.S. Consulate General Daniel A. Kracov, Partner, Arnold & Porter LLP Angela Fan Chi Kung, Partner, Pinheiro Neto Advogados Areta L. Kupchyk, Partner, Nixon Peabody LLP Elaine C. Messa, Executive Vice President of Medical Device Practice, Becker & Associates Consulting, Inc.

Gilberto Ayres Moreira, Partner, Rolim, Viotti & Leite Campos Jose Carlos Nogueira, Partner, Vicente Nogueira Advogados Sarah Roller, Partner, Kelley Drye John Russell, Partner, K &L Gates Eliana A. Silva de Moraes, President, Silva de Moraes Advogados Associados Benny Spiewak, Senior Partner, Zancaner Costa, Bastos e Spiewak Advogados Anne Laure Tardy, Scientific and Regulatory Affairs Consultant, RNI Consulting Group Kim J. Walker, Partner, Faegre, Baker, Daniels LLP

LOCATION
Hilton So Paulo Morumbi
Av. Das Nacoes Unidas, 12901, Sao Paulo, S, 04578-000, Brazil Rate: Single 679 BRL ($334 USD), Double 709 BRL ($349 USD) Reservation Cut-off Date: August 9th To make a reservation contact: Celise Moreira, Groups Coordinator Tel.: (+55) 11 2845-0106 Email: celise.moreira@hilton.com Visit the hotel website: www.fdli.org/brazil
Register Online: www.fdli.org/brazil

September 1011, 2012 | So Paulo, Brazil

U.S. & BRAZIL CONFERENCE 2012

3 REASONS THIS IS A MUST-ATTEND EVENT


Regulators will discuss existing and emerging issues in law, regulation and trade between the U.S. and Brazil. A unique opportunity to learn from and network with professionals with similar business and professional interests. Representatives from multinational and Brazilian companies will share success stories and lessons learned from doing business in Brazil.

REGISTER TODAY, SAVE THROUGH AUGUST 9, 2012. www.fdli.org/brazil


The Food & Drug Law Institute 1155 15th Street, NW, Suite 800 Washington, DC 20005