Day 1: September 10, 2012
7:00–8:15 AM
General Registration/Breakfast
(Morumbi Ballroom Foyer)
8:15–8:30 AM
Welcoming Remarks
(Morumbi Ballroom A & B)
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: Food and Drug Law in Brazil and the United States: Strategic Overview and Look Ahead
(Morumbi Ballroom A & B)
Officials of the Brazilian National Health Vigilance Agency (ANVISA)and the U.S. Food and Drug Administration (FDA) discuss significant developments in the regulation of the pharmaceutical, medical device and food industries.
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)
9:30–10:00 AM
Keynote Address: How Brazil is Transforming the Global Economy
(Morumbi Ballroom A & B)
Julia E. Sweig, PhD, Nelson and David Rockefeller Senior Fellow for Latin America Studies and Director for Latin America Studies, Council on Foreign Relations - (Unable to present due to emergent circumstance)
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
10:00–10:30 AM
Networking Break
(Morumbi Ballroom Foyer)
10:30–12:00 PM
Plenary Session: Doing Business in Brazil: Pathways to Success, Innovation and Access under the Legal Framework
(Morumbi Ballroom A & B)
Now the sixth largest economy in the world, Brazil is a key emerging market for medical and food products and a global hotspot of productivity and innovation. This panel, composed of leading decision makers of multinational companies, attorneys, economic experts and business strategists, will discuss achievements and lessons learned and offer real-world advice for doing business in Brazil.
Fabiano Andreatta, Legal Affairs Manager, Brazil, Eli Lilly
Gregory S. Barnett, Foreign Legal Consultant, Angelico Advogados
Paulo José Rosito Fonseca, Amgen Brazil (Bergamo), Head of Legal, Brazil
Moderated by Otto Licks, Partner, Licks Advogados
12:00–1:20 PM
Luncheon Address: Case Study: How GE Successfully Marketed to the Brazilian Consumer
(Meeting Rooms 5-7)
Sponsored by K & L Gates
Eduardo Calderari, Director of Healtheconomics Latam, GE Healthcare
1:30–3:00 PM
Break-Out Session: Comparative Analysis of U.S. and Brazilian Regulatory Schemes
A. Food: Defining Food in Brazil and the United States
(Meeting Room 3 & 4)
In the United States, regulation of food safety and labeling at the federal level is primarily under the province of: the Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). In Brazil, numerous agencies and several Ministries share jurisdiction for ensuring the safety of the food supply. In this panel, you’ll learn about the similarities and differences in how each government classifies, monitors and regulates the food supply, including;
- How the basic regulatory structure for food is different in Brazil and the United States;
- 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 regulatory bodies in both Brazil and the United States.
Luiz R. M. Silva, Director, Reference Standard Laboratory, United States Pharmacopeia
Anne Laure Tardy, PhD, Scientific and Regulatory Affairs Consultant, RNI Consulting Group
Kim J Walker, Partner, Faegre, Baker, Daniels LLP
Moderated by Sarah Roller, Partner, Kelley Drye
B. Pharmaceuticals/ Biologics: Latest Rules for Approvals of Biosimilars, Complex Drugs and Bioequivalence Standards in Brazil and the United States
(Morumbi Ballroom A & B)
Panelists will discuss recent legislation, regulation and guidance covering these cutting edge topics. Both Brazil and the U.S. recently passed laws in this area, but they utilize substantially different approaches. For example, unlike the U.S., Brazil does not recognize a data exclusivity period for a company introducing a biologic. In addition, Brazilian law does not apply to complex drugs — a complicating factor for innovators.
In this panel, you’ll learn:
- How to distinguish between biosimilar and innovator approaches;
- How to develop data packages and clinical trial data access while maintaining confidentiality; and,
- How to deal with the status of current and predicted harmonization efforts.
Philip Katz, Partner, Hogan Lovells LLP and Director, FDLI Board
J. Michael Nicholas, PhD, Sr. Director, Life Cycle Initiatives, Teva Pharmaceuticals
José Carlose Nogueira, Partner, Vicente Nogueira Advogados
Moderated by Benny Spiewak, Senior Partner, Zancaner Costa, Bastos e Spiewak Advogados
C. Medical Products: Clinical Research in Brazil and the United States
(Morumbi Ballroom C)
As medical products become increasingly globalized, so too has research and development. Meeting product approval requirements in more than one country is important to a company’s bottom line, which makes understanding the host country’s regulatory requirements essential. This panel will explore areas of harmonization between U.S. and Brazilian regulation of clinical trials, as well as important distinctions between the two jurisdictions. In this panel, you’ll learn:
- How to navigate the rules for clinical research and the process for protocol approval and initiating trials;
- Approaches to dealing with subject recruitment and enrollment and obtaining informed consent; and
- Complying with monitoring of trials and reporting responsibilities to ANVISA and FDA.
André Abrahão, MD, Medical Manager, Merck Brazil
Angela Fan Chi Kung, Partner, Pinheiro Neto Advogados
Eric D. Kupferberg, PhD, Senior Assistant Dean, Academic & Faculty Affairs, College of Professional Studies, Northeastern University
John S. Russell, Partner, K &L Gates
Moderated by Daniel A. Kracov, Partner, Arnold & Porter LLP
3:00–3:30 PM
Networking Break
(Morumbi Ballroom Foyer)
3:30–4:45 PM
Break-Out Session: Hot Topics
A. Food Safety in the U.S. and Brazil:
(Meeting Room 3 & 4)
The FDA Food Safety Modernization Act (FSMA) instituted new accountability provisions, including; importer accountability, third-party accreditation, voluntary qualifier importer programs and denial authority.
Learn how food safety regulations are changing in the U.S. and Brazil, including;
- How FSMA requirements influence food imports in the U.S.;
- How to develop and implement a foreign supplier verification program that is right for your business; and
- How to comply with food safety requirements in Brazil.
Zeide Lúcia Gusmão, Specialist in Industrial Development, National Bureau SENAI
Christian Lohbauer, PhD, Executive President of the Brazilian Association of Citrus Exporters – CitrusBR
Diane C. McEnroe, Partner, Sidley Austin LLP
Moderated by Leslie T. Krasny, Partner, Keller and Heckman LLP and Director, FDLI Board
B. Medical Devices: Latest Brazilian and U.S. Approval Initiatives
(Morumbi Ballroom C)
Panelists will explore regulatory changes affecting the launch of medical devices as well as learn how to navigate GMP inspection requirements in the U.S. and Brazil. In this session, you will learn how to secure and maintain adequate reimbursement for innovative medical devices in Brazil & the U.S., including;
- Plan for advanced clinical trials & timelines in Brazil: from first-in-man to pivotal trial;
- Navigate & plan for GMP inspection requirements required for Brazil & US product approval; and
- Improve communication between sponsors, investors and;
- Reimbursement for innovative technologies.
Carlos Eduardo Gouvea, President, Brazilian Alliance for Health Industry Innovator (ABIIS)
Karl M. Nobert, Of Counsel, Squire Sanders
Gerard Zapiain, Senior International Trade Specialist, Health Industries, MBA-IT, PMP, U.S. Department of Commerce
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
(Morumbi Ballroom A & B)
Panelists will discuss the increasingly complex area of inspections and registrations in both the U.S. and Brazil. Hear firsthand about the user fee provisions just enacted under the Food and Drug Administration Safety and Innovation Act (FDASIA).
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
Areta L. Kupchyk, Partner, Nixon Peabody LLP
José Alexandre Buaiz Neto, Partner, Pinheiro Neto Advogados
Moderated by Frederick R. Ball, Partner, Duane Morris LLP and Director, FDLI Board
5:00–5:30 PM
Keynote Address: How Novartis Game Planned it’s Brazilian Approach
(Morumbi Ballroom A & B)
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
5:30PM–6:30 PM
Cocktail Reception
(Morumbi Ballroom Foyer)
Day 2: September 11, 2012
7:30–8:30 AM
Attorney Meet–and–Greet Breakfast
(Morumbi Ballroom C)
Interested in learning more about the practice of food and drug law in Brazil and/or the U.S. – or becoming a foreign legal consultant?
Join us for breakfast to learn the nuts and bolts of practicing law in Brazil, which will include discussion of the regulatory requirements for foreign attorneys practicing in Brazil and a meet-and-greet opportunity with Brazilian attorneys. Take advantage of this chance to network with local attorneys who are currently partnering with, or looking to partner with, international counsel and companies doing business in Brazil.
José Ricardo de Bastos Martins, Partner, Peixoto e Cury Advogados
Lewis Rose, Partner, Kelley Drye
Sponsored by Peixoto e Cury Advogados
8:30–9:00 AM
Brazilian Market Access Issues from the Perspective of the U.S. Consulate’s Office
(Morumbi Ballroom A & B)
Miguel A. Hernández, Commercial Officer/Standards Officer for South America, U.S. Commercial Service, U.S. Consulate
9:00–10:30 AM
Plenary Session: The Influence of Trade Associations in the International Marketplace
(Morumbi Ballroom A & B)
In this roundtable discussion, top-level executives of the leading trade associations representing Brazilian and multinational industry will discuss their role in promoting medical device, pharmaceutical and law and regulation issues in a global marketplace.
Antonio Britto, Executive President, Brazilian Association of Pharmaceutical Industry Research, Interfarma - (Unable to present)
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
10:30–11:00 AM
Networking Break
(Morumbi Ballroom Foyer)
11:00–12:15 PM
Plenary Session: Risks and Advantages of Global Supply Chain Management
(Morumbi Ballroom A & B)
As supply chains become increasingly complex, new challenges and strategies to mitigate risks become crucial to medical product and food companies. In this session, panelists will discuss supply chain management, including; risk management strategies; tracking and traceability; and data information requirements.
Mark Paxton, Regulatory Counsel, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Luiz Evangelista, Asset Management Manager, CHEP Brazil
Dr. Tiago Rauber, Manager of Inspection and Control of Medicines and Products, National Health Surveillance Agency (ANVISA)
Jose Ribamar, BU Quality & Food Safety Leader, Starches and Sweeteners South America, Cargill
Moderated by David Acheson, MD, Partner and Managing Director, Food and Import Safety, Leavitt Partners LLC
12:30–1:50 PM
Lunch
(Meeting Rooms 5-7)
Sponsored by Northeastern University
2:00–3:15 PM
Break out Session: Ensuring Consumer Protection: Best Practices
A. Food: The Tastes of the Brazilian Consumer
(Meeting Room 3 & 4)
The market for functional foods is expected to grow exponentially. With recently relaxed regulations for functional food registration and changing consumer preferences, the opportunities for innovation, brand recognition and market growth are immense. Companies trading food internationally must consider the legal, regulatory and policy constraints of marketing and selling foods in Brazil; including: labeling requirements, additive permissibility, advertising restrictions and compositional requirements.
Learn about the challenges and opportunities for functional foods and health products in Brazil, including;
- Why current food labeling restrictions and labeling requirements are critical for the future of functional food development and approval;
- How to successfully position your company for entry into an evolving market and adapt to Brazilian consumer preferences to aid in brand recognition; and
- How the latest food additive permissibility and maximum levels for certain food categories, including approved additives, compositional requirements and opportunities for technological innovation and development for functional food ingredients affect your business.
Amanda Poldi, Gerente de Assuntos Regulatórios, Cargill Brasil
Antonio Marcos Pupin, Public and Regulatory Affairs, Nestlé Brasil
Moderated by Eliane Miyazaki, Consultant, FoodStaf
B. Medical Products: Post Market Surveillance and Enforcement in Brazil and the U.S.
(Morumbi Ballroom C)
As multinational companies increase the volume of product sales abroad, understanding country-specific post-market surveillance systems is crucial to monitoring product safety and increasing sales. Through a look at the key elements of an effective compliance handling system and recent case studies, experts in the Brazilian regulatory structure and representatives from multinational companies with experience in the Brazilian market will discuss:
- How to comply with adverse event reporting, including understanding new concepts such as counterfeit reporting presented in Brazilian regulation RDC67/2009;
- How to deal with the Brazilian Sentinel network in terms of the profile of the public network that reports malfunctions and adverse events to regulators; and
- How to comply with current requirements to achieve compliance management of product recalls, market withdrawals and field action.
Alexandre Dalmasso, Legal Director, Astellas Farma Brasil
Eliana A. Silva de Moraes, PhD, Partner, Silva de Moraes Advogados Associados & Chair, Brazilian Sanitary Surveillance Professionals Association
Douglas B. Farquhar, Partner, Hyman, Phelps & McNamara, P.C.
Moderated by Jennifer Bragg, Partner, Skadden Arps Slate Meager & Flom LLP
C. Medical Products: IP Issues
(Morumbi Ballroom A & B)
Understanding the connection between intellectual property, law and government initiatives is paramount for pharmaceutical and medical device companies doing business in the U.S. and Brazil. In this session, panelists will discuss the complex connection between patents, trademarks, data protection and copyrights in both countries.
Nuno Pires de Carvalho, Director, Intellectual Property and Competition Policy Division, World Intellectual Property Organization (WIPO)
Eduardo Hallak, Partner, Licks Advogados
Albert Keyack, Latin America Attache, United States Patent and Trademark Office
Moderated by Charles J. Raubicheck, Partner, Frommer Lawrence & Haug LLP
3:15–3:45 PM
Networking Break
(Morumbi Ballroom Foyer)
3:45–5:00 PM
Plenary Session: What You Really Need to Know about Importing into the United States and Brazil
(Morumbi Ballroom A & B)
Government officials from the FDA and ANVISA will explain what you really need to know about importing food and medical products into the U.S. and Brazil, including: key import admissibility issues; what to expect during inspections; and how to comply with complex documentation and labeling requirements. Panelists from the U.S. and Brazil will also discuss specific issues that will help your company bring a product to market as quickly and seamlessly as possible, as well as discuss key marketing issues for products imported to the U.S.
Domenic J. Veneziano, Director, Division of Import Operations & Policy, Office of Regional Operations & CDR Public Health Service, FDA
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
Speaker and Moderator: Leslie Glick, Partner, Porter Wright Morris & Arthur LLP
5:00–5:30 PM
Keynote Address: U.S.-Brazilian and Latin American Cooperation in Food, Drug and Device Regulation: The FDA Regional Director Perspective
(Morumbi Ballroom A & B)
Michael Rogers, Director, Latin America Office, U.S. Food and Drug Administration
Introduced by Geoffrey M. Levitt, Senior VP & Associate General Counsel, Regulatory & Policy, Pfizer, Inc. and Chair, FDLI Board