fdli us-brazil program 2012

7/31/2019 FDLI US-Brazil Program 2012

1/8

U.S. & BRAZILNavigating New Frontiers in Pharmaceutical,

Medical Device and Food Law and Regulation

September 1011, 2012 | So Paulo, Brazil

REGISTER ONLINE TODAY & SAVE www.dli.org/brazilAGEN

DA

INSIDE


2/8

U.S. & Brazil Conerence | Sept. 1011, 2012 | So Paulo, Brazil

DIAMOND SPONSOR

GOLD SPONSORS

BRONZE SPONSORS

NETWORKING BREAKFASTSPONSOR

CONFERENCE SPONSORS

Multinational companies are investing billions in emerging markets; domestic governments and international

organizations are working together to establish laws and regulations to reect this growing international industry.

Sponsoring this conerence provides an opportunity or your company to establish itsel as a leader in the global

ood and drug law community. Learn more at www.dli.org/brazil.

WHY ORGANIZATIONS ARE SPONSORING

ACADEMIC/NON-PROFITSPONSOR

SILVER SPONSORS

CONFERENCE TOTESPONSOR

LUNCHSPONSOR


3/8

Register Online: www.dli.org/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 ood industries, dramatically aecting the operations o both

multinational and Brazilian companies. I youre doing business or thinking o doing business in Brazil,

you need to know the regulatory landscape. At this event, you will hear directly rom top Food and

Drug Administration (FDA) and National Health Surveillance Agency (ANVISA) ocials, on-the-ground

multinational and Brazilian manuacturer representatives, experienced attorneys, and recognized

international trade and import experts on how U.S. and Brazilian legal, regulatory and policy changes

are aecting your responsibilities.

Join us or this landmark conerence that will ocus on business opportunities and policy challenges o

successully producing products or 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 rom and network with proessionals with similar business and

proessional interests.

Representatives rom multinational and Brazilian companies will share success stories and lessons

learned rom doing business in Brazil.

WHO WILL ATTEND

Food and Drug Attorneys

Government Ocials

Academics

Food and Drug Industry Consultants

Venture Capitalists and Investment Brokers

Regulatory Aairs Proessionals

Government Aairs Proessionals

Saety Ocers

Compliance Ocers

Legal Counsel

Business Development Proessionals

Global Strategy Proessionals

Corporate Planning Proessionals


4/8


Day 1 September 10th

7:308:30 am

Registration and Networking Breakast

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 pmNetworking 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


5:005:30 pm

Keynote Address

5:306:30 pm

Cocktail Reception

Day 2 September 11th

7:308:30 am

Attorney MeetandGreet Breakast

8:4510:15 am

General Session

Inuence o Trade Associations

in the International Marketplace

10:45 am12:15 pm

General Session

Risks and Advantages o Global

Supply Chain Management

12:152:00 pmLunch Address

Spotlight on Brazil: The World Cup 2014

and the Olympics 2016. Is Your Brand Ready?

2:003:15 pm

Break-Out Sessions


3:305:00 pm

General Session

What You Really Need to Know aboutImporting 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 ocials o the Brazilian National Health Vigilance Agency (ANVISA) and the U.S. Food and DrugAdministration (FDA) will discuss signifcant developments in the regulation o the pharmaceutical,medical device and ood 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 theagencys top representative on the ground.

SCHEDULE AT-A-GLANCEThe conerence website is being updated daily, visitwww.dli.org/brazil or the most up-to-date agenda and inormation.


5/8

Register Online: www.dli.org/brazil

Doing Business in Brazil: Pathways to Success, Innovation and Access

Leading decision-makers o multinational companies will discuss dierent models or success in Brazil.

How to Develop Products or the Brazilian Consumer: Success Stories

Top-level representatives rom global medical products and ood manuacturers will share insights into

how to appeal to the unique nature o the Brazilian consumer.

The Inuence o Trade Associations in the International Marketplace

During this roundtable discussion, executives o the leading trade associations representing Brazilian andmultinational industry will discuss their role in promoting the medical device, pharmaceutical and oodindustries nationally and internationally, providing one o the most comprehensive trade associationsorums ever held or these industries.

International Supply Chain Management

Panelists will discuss risks and advantages o supply chain management, including risk managementstrategies, tracking and traceability, inormation requirements and ecient supply chain lanes, andinrastructure 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 ood and medical products into the U.S.and Brazil: including key import admissibility issues, critical supply chain considerations, what to expect duringinspection, and how to comply with complex documentation and labeling requirements.

FEATURED PANEL DISCUSSIONS

INDUSTRY SPECIFIC BREAK-OUT SESSIONS

Food Topic Sessions

1. Defning Food in Brazil and the United States

Learn how to communicate eectively with Brazilian and U.S. ocials on ood-related issues and how tonavigate important jurisdictional distinctions and interactions between the various regulatory bodies inboth countries.

2. The U.S. FDA Food Saety Modernization Act (FSMA): Changing the Rules for Food Imports

Panelists will explain evolving import and accreditation requirements under FSMA.

3. The Tastes o the Brazilian Consumer

Panelists will discuss the legal, regulatory and policy constraints o marketing and selling oods in Braziland the U.S. (labeling requirements, additive permissibility, advertising restrictions, and compositionalrequirements).


6/8


Medical Products Topic Sessions

1. Comparative Analysis o Regulatory Schemes

Latest Rules or Approvals o Biosimilars, Complex Drugs and Bioequivalence Standards in Braziland the U.S (Pharmaceutical and Biologics)

Panelists will detail the latest rules or approvals o biosimilars, complex drugs and bioequivalence

standards, including how to distinguish dierences between the biosimilar and stand-alone approaches,data packages, clinical trial data access and confdentiality, and current and uture harmonization eorts.

Clinical Research in Brazil and the United States (Medical Device and Pharmaceutical)Panelists will analyze key issues in clinical research including areas o harmonization between U.S.and Brazilian regulation o clinical trials; important distinctions; how to navigate clinical research andthe process or protocol approval and initiating trials; subject recruitment, enrollment and obtaininginormed consent; and complying with the monitoring o 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 aecting the launch o medical devices as well as navigatingGMP inspection requirements essential or U.S. and Brazilian product approvals.

Drug Registration and Inspections in the U.S. and Brazil (Pharmaceutical)

Panelists will discuss the increasingly complex area o inspections and registration in the U.S. and Brazil.

3. Ensuring Consumer Protection: Best Practices

Post Market Surveillance and Enorcement in Brazil and the U.S. (Medical Device and Pharmaceutical)

Panelists will detail post market surveillance and enorcement including eective complaint handlingsystem; complying with adverse event reporting requirements; dealing with the Brazilian Sentinelnetwork; and current requirements or product recalls, market withdrawals and feld action.

Intellectual Property Issues and Developments (Pharmaceutical)

Panelists will analyze intellectual property issues including: patents, trademarks, copyrights and dataprotection; patent term extension and the rise o patent litigation and legislation in the U.S.; review opatent applications in Brazil by ANVISA and Brazilian National Industrial Property Institute; biodiversityand genetic patrimony issues; and the connection between intellectual property, regulatory law andgovernment initiatives in both countries.

SPECIAL NETWORKING EVENT

Attorney MeetandGreet Breakast Sponsored by Peixoto e Cury Advogados

Join us or breakast to learn the nuts-and-bolts o practicing law in Brazil, includingthe regulatory requirements or oreign attorneys. Take advantage o this rareopportunity to network with local attorneys who are currently partnering with, orlooking to partner with, international counsel and companies doing business in Brazil.


7/8Register Online: www.dli.org/brazil

FEATURED SPEAKERS

LOCATION

Deborah M. Autor, DeputyCommissioner or Global Regulatory

Operations and Policy, FDA

Mark Paxton, Regulatory Counsel,CDER, FDA

Michael Rogers, Director, LatinAmerica Oce, FDA

Domenic J. Veneziano, Director,Division o Import Operations &Policy, Oce o Regional Operations

& CDR Public Health Service, FDA

David Acheson, MD, Partnerand Managing Director, Food andImport Saety, Leavitt Partners LLC

Frederick R. Ball, Partner,Duane Morris LLP

Gregory S. Barnett, Foreign LegalConsultant, Angelico Advogados

William H. Bill Dufell, Sr. VicePresident, Medtronic, Inc.

Douglas B. Farquhar, Attorney,Hyman, Phelps & McNamara, P.C.

Leslie Glick, Partner, Porter WrightMorris & Arthur LLP

Albert T. Keyack, Consul orIntellectual Property Rights, Latin

American Region, U.S. ConsulateGeneral

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 VicePresident o 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 AdvogadosAnne Laure Tardy, Scientifcand Regulatory Aairs Consultant,RNI Consulting Group

Kim J. Walker, Partner,Faegre, Baker, Daniels LLP

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-of Date:

August 9th

To make a reservation contact:

Celise Moreira, Groups Coordinator

Tel.: (+55) 11 2845-0106

Email: [email protected]

Visit the hotel website:

www.dli.org/brazil

Additional government ocials and speakers have been invited, and once confrmed,

will be updated on www.fdli.org/brazil


8/8

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

The Food & Drug Law Inst itute1155 15th Street, NW, Suite 800

Washington, DC 20005

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 rom and network with proessionals with similar business and

proessional interests.

Representatives rom multinational and Brazilian companies will share success stories and lessons

learned rom doing business in Brazil.

U.S. & BRAZIL CONFERENCE 2012September 1011, 2012 | So Paulo, Brazil

fdli us-brazil program 2012

Documents