Attendees will receive a flash drive on site containing presentations received prior to August 27.
Os participantes receberão um flash drive no local contendo apresentações recebidas antes do dia 27 de agosto.
Day 1: September 10, 2012
8:15–8:30 AM
Welcoming Remarks
Susan C. Winckler, President & CEO, FDLI
Eduardo Dantas, President, Brazilian Association for Health, Vice President, World Association for Medical Law
8:30–9:30 AM
Keynote Address #1: Food and Drug Law in Brazil and the United States: Strategic Overview and Look Ahead
Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy, U.S. Food and Drug Administration
Dr. Norberto Rech, Special Advisor of Director Chairman, National Health Surveillance Agency (ANVISA) | Slides
9:30–10:00 AM
Keynote Address #2: How Brazil is Transforming the Global Economy
Julia E. Sweig, PhD, Nelson and David Rockefeller Senior Fellow for Latin America Studies and Director for Latin America Studies, Council on Foreign Relations | Handout
Introduced by Donizetti Louro, Professor and Advisor to the Rector of the Pontifical Catholic University of Sao Paulo PUC-SP and head of the Innovation and Technology Transfer, PUC SP
10:30–12:00 PM
Plenary Session #1: Doing Business in Brazil: Pathways to Success, Innovation and Access under the Legal Framework
Fabiano Andreatta, Legal Affairs Manager, Brazil, Eli Lilly | Slides
Gregory S. Barnett, Foreign Legal Consultant, Angelico Advogados
Paulo José Rosito Fonseca, Amgen Brazil (Bergamo), Head of Legal, Brazil | Slides
Sérgio De Regina, General Counsel, Cristália Produtos Químicos e Farmacêuticos
Moderated by Otto Licks, Partner, Licks Advogados | Slides
1:30–3:00 PM
Break-Out Session #1: Comparative Analysis of U.S. and Brazilian Regulatory Schemes
A. Food: Defining Food in Brazil and the United States
Luiz R. M. Silva, Reference Standard Laboratory, Director, United States Pharmacopeia | Slides
Anne Laure Tardy, PhD, Scientific and Regulatory Affairs Consultant, RNI Consulting Group | Slides
Kim J Walker, Partner, Faegre, Baker, Daniels LLP | Slides
Moderated by Sarah Roller, Partner, Kelley Drye & Warren LLP | Slides
B. Pharmaceuticals/ Biologics: Latest Rules for Approvals of Biosimilars, Complex Drugs and Bioequivalence Standards in Brazil and the United States
Philip Katz, Partner, Hogan Lovells LLP and Director, FDLI Board | Slides
J. Michael Nicholas, PhD, Sr. Director, Life Cycle Initiatives, Teva Pharmaceuticals | Slides
José Carlose Nogueira, Partner, Vicente Nogueira Advogados | Slides
Moderated by Benny Spiewak, Senior Partner, Zancaner Costa, Bastos e Spiewak Advogados
C. Medical Products: Clinical Research in Brazil and the United States
Angela Fan Chi Kung, Partner, Pinheiro Neto Advogados | Slides
Eric D. Kupferberg, PhD, Senior Assistant Dean, Academic & Faculty Affairs, College of Professional Studies, Northeastern University | Slides
John S. Russell, Partner, K&L Gates LLP | Slides
Moderated by Daniel A. Kracov, Partner, Arnold & Porter LLP
3:30–4:45 PM
Break-Out Session #2: Hot Topics
A. Food Safety in the U.S. and Brazil:
Zeide Lúcia Gusmão, Specialist in Industrial Development, National Bureau SENAI | Slides
Christian Lohbauer, PhD, Executive President of the Brazilian Association of Citrus Exporters – CitrusBR | Slides
Diane C. McEnroe, Partner, Sidley Austin LLP | Slides
Moderated by Leslie T. Krasny, Partner, Keller and Heckman LLP and Director, FDLI Board | Slides
B. Medical Devices: Latest Brazilian and U.S. Approval Initiatives
Carlos Eduardo Gouvea, President, Brazilian Alliance for Health Industry Innovator (ABIIS)
Karl M. Nobert, Of Counsel, Squire Sanders | Slides
Gerard Zapiain, Senior International Trade Specialist, Health Industries, MBA-IT, PMP, U.S. Department of Commerce | Slides
Moderated by William H. "Bill" Duffell, Jr., PhD, Vice President, Medtronic, Inc.
C. Pharmaceuticals: Registration, Inspections and User Fees in the U.S. and Brazil
Wade Ackerman, Associate Chief Counsel for Drugs, Office of Chief Counsel, Office of the Commissioner, FDA
Freddy A. Jimenez, Assistant General Counsel, Office of the General Counsel, Johnson & Johnson | Slides
Areta L. Kupchyk, Partner, Nixon Peabody LLP | Slides
José Alexandre Buaiz Neto, Partner, Pinheiro Neto Advogados | Slides
Moderated by Frederick R. Ball, Partner, Duane Morris LLP and Director, FDLI Board | Slides
5:00–5:30 PM
Keynote Address #3: How Novartis Game Planned it’s Brazilian Approach
Alexander Triebnigg, President, Novartis-Brazil
Introduced by Luciano O. Ferreira, Regulatory Intelligence Manager, Latin America, GE Healthcare & Coordinator Professor, Pontifical Catholic University of São Paulo
Day 2: September 11, 2012
7:30–8:30 AM
Attorney Meet–and–Greet Breakfast
José Ricardo de Bastos Martins, Partner, Peixoto e Cury Advogados | Slides
Lewis Rose, Partner, Kelley Drye
8:30–9:00 AM
Brazilian Market Access Issues from the Perspective of the U.S. Consulate’s Office
Miguel A. Hernández, Commercial Officer/Standards Officer for South America, U.S. Commercial Service, U.S. Consulate
9:00–10:30 AM
Plenary Session #2: The Influence of Trade Associations in the International Marketplace
Antonio Britto, Executive President, Brazilian Association of Pharmaceutical Industry Research, Interfarma
Paulo Henrique Fraccaro, Vice President, Brazilian Medical Devices Manufacturers Association (ABIMO)
Ralph Ives, Executive Vice President, Global Strategy and Analysis, Advanced Medical Technology Association (AdvaMed)
Erik Lieberman, Regulatory Counsel, Food Marketing Institute (FMI)
Andrew Rudman, Deputy Vice President for the Western Hemipshere, Pharmaceutical Research and Manufacturers of America (PhRMA)
Moderated by Eduardo Dantas, President, Brazilian Association for Health Law, Vice-President, World Association for Medical Law
11:00–12:15 PM
Plenary Session #3: Risks and Advantages of Global Supply Chain Management
Mark Paxton, Regulatory Counsel, Center for Drug Evaluation and Research, U.S. Food and Drug Administration | Slides
Luiz Evangelista, Asset Management Manager, CHEP Brazil | Slides
Dr. Tiago Rauber, Manager of Inspection and Control of Medicines and Products, National Health Surveillance Agency (ANVISA) | Slides
Jose Ribamar, BU Quality & Food Safety Leader, Starches and Sweeteners South America, Cargill | Slides
Moderated by David Acheson, MD, Partner and Managing Director, Food and Import Safety, Leavitt Partners LLC | Slides
2:00–3:15 PM
Break out Session #3: Ensuring Consumer Protection: Best Practices
A. Food: The Tastes of the Brazilian Consumer
Eliane Miyazaki, Consultant, FoodStaff | Slides
Amanda Poldi, Gerente de Assuntos Regulatórios, Cargill Brasil | Slides
Antonio Marcos Pupin, Public and Regulatory Affairs, Nestlé Brasil | Slides
B. Medical Products: Post Market Surveillance and Enforcement in Brazil and the U.S.
Alexandre Dalmasso, Legal Director, Astellas Farma Brasil | Slides
Eliana A. Silva de Moraes, PhD, Partner, Silva de Moraes Advogados Associados & Chair, Brazilian Sanitary Surveillance Professionals Association | Slides
Douglas B. Farquhar, Partner, Hyman, Phelps & McNamara, P.C. | Slides
Moderated by Jennifer Bragg, Partner, Skadden Arps Slate Meager & Flom LLP
C. Medical Products: IP Issues
Nuno Pires de Carvalho, Director, Intellectual Property and Competition Policy Division, World Intellectual Property Organization (WIPO) | Slides
Eduardo Hallak, Partner, Licks Advogados | Slides
Albert Keyack, Latin America Attache, United States Patent and Trademark Office | Slides
Moderated by Charles J. Raubicheck, Partner, Frommer Lawrence & Haug LLP | Slides
3:45–5:00 PM
Plenary Session #4: What You Really Need to Know about Importing into the United States and Brazil
Domenic J. Veneziano, Director, Division of Import Operations & Policy, Office of Regional Operations & CDR Public Health Service, FDA | Slides
Dr. Solange Marques Coelho, Manager of Inspection and Control of Products in Port, Airports and Borders, National Health Surveillance Agency (ANVISA)
Gilberto Ayres Moreira, Partner, Rolim, Viotti & Leite Campos
Alec Rosen, President & CEO, AJR Partners, Inc | Slides
Moderated by Leslie Glick, Partner, Porter Wright Morris & Arthur LLP
5:00–5:30 PM
Keynote Address #5: U.S.-Brazilian and Latin American Cooperation in Food, Drug and Device Regulation: The FDA Regional Director Perspective
Michael Rogers, Director, Latin America Office, U.S. Food and Drug Administration | Slides
Introduced by Geoffrey M. Levitt, Senior VP & Associate General Counsel, Regulatory & Policy, Pfizer, Inc. and Chair, FDLI Board