The Food and Drug Law Institute

US-China Food And drug LAwEnsuring Quality, Improving Safety, Expanding Access June 13-14, 2011 | Beijing, China | www.fdli.org/china

In Partnership with Tsinghua University School of Law and Health Law Research Center

Conference Overview

About the Conference

The Food and Drug Law Institute (FDLI) is hosting a conference addressing food and drug law, regulation and policy in China and the United States. Government officials and internationally renowned experts will discuss the current legal, regulatory and economic environment for the development of food, cosmetics, dietary supplements, pharmaceuticals and medical devices in both countries. The conference will focus on business opportunities and policy challenges in producing safe products and promoting health for a combined market of more than 1.6 billion consumers.

who Should Attend

Representatives of multi-national food, cosmetic, dietary supplement, pharmaceutical and medical device companies doing business or planning to do business in China including:

Regulatory and Government Affairs Personnel Business Development, Global Strategic Officials and Corporate Planners Safety and Compliance Officers

Representatives of Chinese food, cosmetic, dietary supplement, pharmaceutical and medical device companies or those who wish to partner with these companies

Food and Drug Attorneys Government Officials Academics Food and Drug Industry Consultants Venture Capitalists and Investment Brokers doing business in China

Location

The conference will be held at the China World Hotel in Beijing. The award-winning luxury hotel is situated right in the heart of Beijing’s diplomatic and central business district and is 45 minutes from Beijing Capital International Airport. For more information about the hotel visit http://www.shangri-la.com/en/property/beijing/chinaworld.

China world HotelNo 1 Jianguomenwai AvenueBeijing 100004China

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registration

Registration includes access to sessions for the entire two-day conference, on-site materials, breakfast, lunch, coffee and refreshments on both days and a networking cocktail reception on June 13, 2011. The conference registration fee does not include hotel accommodations and/or travel to the conference.

early Bird (now through 4/8/11)

Member: $1495Non-member: $1695Government/Academic Member: $600Government/Academic Non-Member: $650 (includes one-year FDLI membership)

registrant (4/9/11-6/9/11)

Member: $1695Non-member: $1995Government/Academic Member: $700Government/Academic Non-Member: $750 (includes one-year FDLI membership)

Chinese Company discount

If you are a Chinese company or a Chinese national, you may be eligible for a discounted registration fee. Contact Aliza Glasner at ayg@fdli.org.

Conference Cd — includes all plenary sessions

$99 with registration | $499 without registration for member | $599 for non-member

FdLi Publication — Available June 2011

Compilation of Selected Chinese State Food and Drug Administration (SFDA) Regulations on Drugs and DevicesEdited by Gordon Schatz, Life Science Partner at Reed Smith LLP (Beijing/ Washington, DC), with assistance of Professor Wang Chenguang, Tsinghua University School of Law and Health Law Research Center (Beijing).

This publication will be a valuable resource of selected SFDA drug and device regulations and will help companies and clients better understand these key Chinese regulations. The publication will be available in English and cover drug and device registration, clinical trials, classification/standards, advertising and other issues.

Special Conference and Pre-Publication Pricing: $149 After the Conference $199 FDLI Members | $299 Nonmembers

Registration Details

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why Your Company Should Attend

Pharmaceutical — The landscape for pharmaceutical regulation in China is changing as clinical trials proliferate and new GMPs take hold. Recently, several US government agencies and China’s Ministries of Health and Commerce established a working group for a public-private partnership in the healthcare sector charged with encouraging research, training and regulation in several areas, including pharmaceuticals. In the US, FDA is increasing its supply chain oversight, post-market surveillance activities and generally clamping down on non-compliers. Understanding the legal and regulatory landscape in China and the US is essential.

Medical Devices — SFDA recently announced 96 new standards for devices, which are scheduled to go into effect June 1, 2012. The US FDA is reviewing its regulatory approach to medical devices. From product development, to clinical trials, to manufacturing and a growing consumer base, both Chinese and multinational companies with an interest in medical devices need to stay current with the changing regulatory and legal landscape in both countries.

Food — The Chinese Ministry of Health will soon be issuing new protocols on investigating food safety incidents and providing additional training for investigators. The Chinese government is reviewing food additive issues. The US Congress recently passed the Food Safety Modernization Act, and President Obama has requested an increase of $170 million in additional funding for FDA’s food program. Staying on top of all of these changes in regulation, law and policy is an absolute necessity for any company working in the food sector.

Cosmetics — China is a rising player in the cosmetic industry as both a major source of raw materials and consumer base. In the United States, FDA approves color additives, operates the Voluntary Cosmetic Registration Program (a post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products), and can pursue enforcement actions against violative cosmetic products, firms and even individuals. Being aware of regulatory developments in both countries can yield more efficient business operations.

Dietary Supplements — SFDA is paying increasing attention to reforming regulation of products the US regulates as dietary supplements. These efforts could enhance China’s role as a manufacturing hub for these products. In the United States, manufacturers are responsible for ensuring that a dietary supplement is safe before it is marketed, but FDA can and does take action against unsafe dietary supplement products.

Supporting Partners

AdvaMed

AmCham China

Becker & Associates Consulting, Inc.

China Association for Medical Device Industry (Invited)

China National Food Industry Association

Drug Information Association

GIC Group/Global Food Safety Forum

Global Cold Chain Alliance

National Consumers League

Natural Products Association

Personal Care Products Council

China Association of Enterprises with Foreign Investment R & D-based Pharmaceutical Association Committee (RDPAC)

US–China Business Council

US–China Health Products Association

Why Attend

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Agenda: DAY ONE — Monday, June 13

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7:30 – 8:30 AMREGIStRAtION/BREAkFASt

8:30 – 8:45 AMWELCOME AND INtRODuCtION• Susan C. Winckler, President and CEO,

FDLI

8:45 – 9:15 AMkEYNOtE ADDRESS• Invited, Chinese Government Official

9:15 – 9:45 AMkEYNOtE ADDRESS• Dr. Margaret A. Hamburg, Commissioner

of Food and Drugs, US Food and Drug Administration

Dr. Hamburg will discuss the FDA Strategic Priorities 2011– 2015 for food and medical products as they relate to the U.S. presence in China.

9:45 – 10:15 AMNEtWORkING BREAk

10:15 – 12:15 PMPLENARY PANELInnovation and Access: Key Success Factors in China• Rosemary Gallant, Principal Commercial

Officer Beijing, US Embassy Beijing, Commercial Section

• Francine Lamoriello, Executive Vice President for Global Strategies, Personal Care Products Council

• Gordon Schatz, Partner, Reed Smith• Wei Sun, Scientific and Regulatory Affairs,

Coca-Cola Greater China

• Adrian Thomas, Worldwide Vice President, Worldwide Market Access, Johnson & Johnson Pharmaceutical Service

• Xiang Wang, Partner, Orrick, Herrington & Sutcliffe, LLP

• Jing Zhang, Director, Regulatory Affairs and Government Affairs, Greater China, BD

• Invited, Chinese Government Official

12:15 – 2:00 PM LuNChEON• Joaquin Pelaez, Senior Vice President and

Chief Support Officer, Yum! Brands, Inc., China Division

2:00 – 2:30 PMCONCuRRENt ChINESE GOvERNMENt ADDRESSES: Food, Dietary Supplements, Medical Devices, Drugs and Cosmetics

2:30 – 4:00 PM INDuStRY SESSIONS: ENSuRING CONSuMER PROtECtION

A) Dietary Supplements Safety Protocol: Understanding US and

Chinese Regulations• Karen A. Eng, President, CSMI• John Venardos, Senior Vice President,

Worldwide Regulatory, Government & Industry Affairs, Herbalife

• Invited, Chinese Government Official

B) Food Food Safety Laws & Regulations:

New Mandates, New Compliance Responsibilities• Irene Chan, Assistant China Country

Director, FDA• John Eldred, Partner, Keller and

Heckman LLP• Matthew Finger, Division FSQA

Manager Asia Pacific, Tyson Foods, Inc.

• Rick Gilmore, President and CEO, GIC Group, Managing Director of the Global Food Safety Forum

• Invited, Chinese Government OfficialC) Drugs/Medical Devices

Globalization of Clinical Trials, Data Integrity and Pre-Market Approvals• David Adams, Partner, Venable LLP• Wang Chenguang, Professor of Law,

Tsinghua University School of Law• Seth Whitelaw, R&D Compliance

Officer, GlaxoSmithKline• Invited, Representative from Chinese

Medical Device Company

D) Cosmetics Modern Approaches to Safety Assessment• Ken Marenus, Senior Vice President

Regulatory Affairs Worldwide, The Estee Lauder Companies

• Carl Westmoreland, Director Science & Technology - Safety & Environmental Assurance Centre, Unilever

4:00 – 4:15 PMNEtWORkING BREAk

4:15 – 5:15 PMINDuStRY SESSIONS: ENFORCEMENt

A) Food Enforcing the Food Safety Law of the

People’s Republic of China and the US Food Safety Modernization Act

• Benjamin England, President and CEO, FDAImports.com, LLC

• Sang Liwei, Bric Global Agricultural Consultant Ltd.

• Frank W. Rocco, Principal, Frank Rocco & Associates

B) Drugs/Medical Devices Crossing the Rubicon: When Regulatory

Concerns Become Enforcement Actions• Chen Yang, Partner, Sidley Austin• Joan McPhee, Partner, Ropes & Gray

LLP• Gael Diane Tisack, Vice President of

Regulatory and Legal Affairs, Terumo Cardiovascular Systems

• Invited, Novartis China• Invited, China Association of

Enterprises with Foreign Investment R & D-based Pharmaceutical Association Committee (RDPAC)

C) Dietary Supplements Enforcing Transparency: Labels,

Ingredients and Health Claims• Jeff Crowther, Executive Director,

US–China Health Products Association• Cara Welch, Vice President of Scientific

& Regulatory Affairs, Natural Products Association

• John Villafranco, Partner, Kelley Drye• Invited, Chinese Government Official

D) Cosmetics The Evolution of Cosmetics Regulatory

Systems in Asia• Francine Lamoriello, Executive Vice

President Global Strategies, US Personal Care Products Council

• Invited, Sameerah Shaikh, National Pharmaceutical Bureau, Ministry of Health, Malaysia

• Invited, Representative from Industry in Korea

• Invited, Chinese Government Official

5:15 – 5:45 PMPLENARY SESSION• Ralph Tyler, Chief Counsel, US Food and

Drug AdministrationMr. Tyler will address the primary legal issues involved in food and drug regulation and the ways in which FDA approaches these issues.

5:45 – 7:00 PMCOCktAIL RECEPtION

Agenda: DAY tWO — tuesday, June 14Ju

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8:00 – 9:00 AMBREAkFASt AND INDuStRY CASE StuDIES:

A) Biosimilars A Global Perspective on Regulatory

Standards and Expectations for Biosimilar Biological Medicines• Erika Lietzan, Partner, Covington and

Burling LLP

B) Regulating Pistachio Nuts A Perspective on Emerging Law and

Corporate Social Responsibility in China’s Food Sector: The “Bleaching” Case Study• Michael T. Roberts, Adjunct Professor

of Law, UCLA School of Law; Co-Director, FDA Center, East China University of Science and Technology, School of Law; Special Counsel, Roll Law Firm PC; Director, Center for Food and Nutrition Policy

C) Intellectual Property Hatch-Waxman Act and its Impact on

the Asian Generic Industry• Mandar Kodgule, Associate Vice

President and Head of Global Intellectual Property and Strategic Planning, Wockhard Ltd

D) Cosmetics Assessing Cosmetic Ingredient Safety

in the United States: The Cosmetics Ingredient Review• Halyna P. Breslawec, Deputy Director,

US Cosmetics Ingredient Review (CIR)

9:00 –10:00 AMPuBLIC-PRIvAtE PARtNERShIPS: NEW DEvELOPMENtS IN uS-ChINA INDuStRY COLLABORAtIONS• Dan Poppy, Associate Managing Bureau

Editor at PharmAsia News• Yu Li, Scientific & Regulatory Affairs, Mars

Foods (China) CO., LTD. • Nancy Travis, Vice President for Global

Strategy and Analysis, Advanced Medical Technology Association (AdvaMed)

• Invited, AmCham• Invited, China Center for Pharmaceutical

International Exchange• Invited, Cosmetics Industry

Representative

10:00 – 10:15AMNEtWORkING BREAk

10:15 – 12:15 PMROuNDtABLE DISCuSSION: DOING BuSINESS IN ChINA• Ron Ginor, MD, President and Medical

Director, Becker & Associates Consulting, Inc., Becker Venture Services Group, LLC

• Matt Salmon, President, Upstream Consulting, Inc.

• Marty Solberg, Vice President Global Regulatory Affairs CMC, Genzyme Corporation

• Robert Poole, Vice President of China Operations, US China Business Council

• Michael Robach, Vice President Corporate Safety and Regulatory Affairs, Cargill

• Rachel Duan, President and CEO, GE Healthcare China

• Invited, Warburg Pincus• Invited, Cosmetics Industry Executive

12:15 – 2:00 PMLuNChEON

2:00 – 2:30 PMCONCuRRENt ChINESE GOvERNMENt ADDRESSES: Food, Dietary Supplements, Medical Devices, Drugs and Cosmetics

2:30 – 4:00 PMINDuStRY SESSIONS: ENSuRING thE QuALItY AND INtEGRItY OF thE GLOBAL SuPPLY ChAIN

A) Food/Dietary Supplements Protecting Consumers from Economic

Fraud: A Multi-Disciplinary Approach• David Acheson, Managing Director,

Food and Import Safety Practice, Leavitt Partners

• Frederick Ball, Partner, Duane Morris, LLP and Adjunct Professor of Law, DePaul University

• Courtney Brein, Linda Golodner Food Safety and Nutrition Fellow, National Consumers League

• Tom Marsden, Dun & Bradstreet• Bill Simos, HACCP Asia

B) Drugs From Raw Materials to Finished Drug

Products: Quality and Access are Key to Economic Success• John Hu, Vice President, US

Pharmacopeia• Greg Levine, Partner, Ropes and Gray• Robert A. Rhoades, Practice Leader,

Quality & Compliance Consulting, Quintiles

C) Medical Devices New Standards, New Issues in Medical

Devices• Jeffrey Gren, Director, Office of

Health and Consumer Goods, US Department of Commerce

• Invited, Linda Lin, Director, Beijing Office, Boston Scientific Corporation

• Steve Niedelman, Lead Quality System and Compliance Consultant, King and Spalding

• Ed Woo, Director Regulatory Affairs, Medtronic Inc., Cardiac Rhythm Disease Management

• Invited, Chinese Government Official

D) CosmeticsTBA

4:00 – 4:15 PMNEtWORkING BREAk

4:15 – 5:15 PMINDuStRY SESSIONS: POSt-MARkEt APPROvALS

A) Food/Dietary Supplements Surveillance and Adverse Event

Reporting• John Mckenzie, General Manager

Sino Analytica Laboratories

• Vincent P. Gordon, Chairman & CEO, Procuro, Inc.

• Antoine Bloch, Vice President Silliker Asia Pacific

B) Drugs/Medical Devices Handling Adverse Events and Recalls:

Protecting the Public, Protecting your Business• Li Cai, Regional R&D Counsel, Asia

Pacific, Pfizer Inc. • Daniel Kracov, Partner, Arnold &

Porter LLP• Michael Loucks, Partner, Skadden,

Arps, Slate, Meagher & Flom LLP• Bruce Patsner, Professor of Law,

University of Houston

C) Cosmetics Global Best Practices in Post-Market

Surveillance• Invited, Representative from EU

industry• Invited, Chinese Government Official• Invited, China AQSIQ Representative

5:15 – 5:45 PMCORNERStONE ADDRESS • Chris Hickey, China Country Director,

FDA

Dr. Hickey will deliver a progress report on ensuring the safety of drugs and food produced in China for export to the United States, addressing challenges and progress from when FDA opened its doors in Beijing in 2007 to today.

5:45 – 6:00 PMCONCLuDING REMARkS • Minnie Baylor-Henry, Worldwide Vice

President, Regulatory Affairs, Johnson & Johnson, Medical Devices and Diagnostics and Chair, FDLI Board of Directors

IMPORTS.COM...The way through

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.fdli.org/chinaSponsors

the Food and drug Law institute1155 15th Street NW, Suite 800Washington, DC 20005

The Food and Drug Law Institute

US-China Food And drug LAw:Ensuring Quality, Improving Safety, Expanding Access June 13-14, 2011 | Beijing, China | www.fdli.org/china

• An opportunity to hear from government officials and regulators, including dr. Margaret A. Hamburg, Commissioner of Food and Drugs, US Food and Drug Administration

• Networking and partnering opportunities with multi-national company representatives and Chinese and uS business leaders, law firms and consultants

• up-to-date information on new Chinese government regulatory initiatives, including soon-to-be released food safety protocols, dozens of new standards for medical devices and innovative public-private partnership opportunities in healthcare

In Partnership with Tsinghua University School of Law and Health Law Research Center