Solving the Challenges of Regulatory Compliance Through Technology
With the changing environment in which prescription and over-the-counter drugs are produced and marketed, this session will address whether and when effective regulation can be achieved through traditional compliance models, as well as FDA’s use of more novel approaches, for example, presence on the Web through targeted outreach, directed messages in publications, etc.

Stephen Paul Mahinka, Partner and Chair, Life Sciences Practice, Morgan, Lewis & Bochius, LLP, moderator
Edward J. Allera, Partner, Buchanan Ingersoll & Rooney PC
Dan Barreto, International Vice President, cGMP Compliance, Ortho-McNeil-Janssen Pharmaceuticals
Gregory M. Hockel, PhD, Senior Vice
President – Worldwide Regulatory Affairs, PharmaNet, Inc.
Steven D. Silverman, Assistant Director, Office of Compliance, CDER, FDA
Roy J. Sturgeon, Executive Vice President, Lachman Consultant Services, Inc.

| Is it a Drug or Is It a Cosmetic?
What claims cross the fine line between drugs and cosmetics? What are the new wrinkles in cosmetic advertising and labeling? Can we inject reason into this discussion or is it all just cover-up? Don't be caught red-faced with a blemish on your enforcement record! Learn the latest from our panel of experts at this lively interactive discussion.

Marsha C. Wertzberger, Partner, Arent Fox, moderator
Farah K. Ahmed, Assistant General Counsel, Personal Care Products Council
(formerly Cosmetics, Toiletries & Fragrances Association)
Linda M. Katz, MD, MPH, Director, Office of Cosmetics 7 Colors, CFSAN, FDA
William A. McGrath, Partner, Wiley Rein, LLP
Ivan J. Wasserman, Partner, Manatt Phelps & Phillips, LLP

| New Technology Reports
This session will examine current initiatives that are directed toward identifying emerging medical device technologies that are likely to undergo major development over the next decade. It will also explore regulatory and other issues that may result from the unfolding of these technology trends. The panel will seek to provide a framework within which members of the medical device community can begin to think about features of the technology landscape that will characterized the next decade.

Mark E. DuVal, President, Duval & Associates, moderator
Ashley B. Boam, Acting Deputy Director for Science and Review Policy, Office of Device Evaluation, CDRH, FDA
William A. Herman, Deputy Director for Science and Strategic Initiatives, Office of Science & Engineering Laboratories, CDRH, FDA
Nancy E. Taylor, Principal Shareholder, Greenberg Traurig
Ronald F. Tetzlaff, PhD, Corporate Vice President, Parexel Consulting

| CBER/Health Canada Safety Initiatives
Biologics product safety is an essential element in the mission of the Center for Biologics Evaluation and Research (CBER) and Health Canada.  Regulatory agencies use multiple approaches to ensure product safety, including postmarketing surveillance and the use of interdisciplinary safety teams.  This session will provide an overview of the agencies' postmarketing surveillance activities along with information about different interdisciplinary safety teams and their objectives, and will address Health Canada's initiatives to develop a pathway to approve follow-on biologics.

Frederick H. Branding, Partner, Reed Smith, moderator
Carmen M. Collazo, PhD, Vaccine Safety Team, Regulatory Project Officer, Microbiologist, Office of Vaccines Research and Review, CBER, FDA
Jonathan C. Goldsmith, MD, Blood Safety Team Chair and Deputy Director, Office of Blood Research and Review, CBER, FDA
Ruth R. Solomon, MD, Tissue Safety Team Chair and Director, Division of Human Tissues, Office of Cellular, Tissue and Gene Therapies, CBER, FDA
Alan West, MD, Partner, Gowlings Lafleur Henderson LLP
Robert P. Wise, MD, MPH, Chief, Therapeutics and Blood Safety Branch, Div. of Epidemiology, Office of Biostatistics and Epidemiology, CBER, FDA

| Across the Border: Canadian Food & Drug Regulations and Law
This session will discuss differences between Canadian and US practices, so decision makers can assess possible strategies in Canada.  The topics include the basis for food and drug law in Canadian legislation; government organizations involved with approval and enforcement; major differences from U.S. law and practice; recent Canadian food and drug case law on the regulatory side, especially advertising, judicial review and enforcement; differences in Canadian patent law - life forms, methods of treatment, possible change in law of selection patents; major evolution and case law under Canada’s Patented Medicine (Notice of Compliance) Regulations (equivalent to Hatch-Waxman); drug pricing and cross-border prescribing issues; and changes and new initiatives.

Gordon S. Jepson, Partner, Deeth Williams Wall LLP, moderator
Brian R. Daley, Partner, Ogilvy Renault LLP

Views from the Center: Implementing the FDA AA in an Age of Rapid Scientific Advancement

| Douglas C. Throckmorton, MD, Deputy Director, Center for Drug Evaluation & Research, FDA
Donald O.  Beers, Partner, Arnold & Porter LLP, moderator
Alan R. Bennett, Partner, Ropes & Gray LLP
Carl C. Peck, MD, Founder and Chairman, NDA Partners
Rady A. Johnson, Senior Vice President and Assistant General Counsel, Pfizer Inc.

| Stephen F. Sundlof, DVM, PhD, Director, Center for Food Safety & Applied Nutrition, FDA
Craig W. Henry, PhD, Senior Vice President of Scientific & Regulatory Affairs, and Chief Operating Officer, Grocery Manufacturers Association, moderator
Daniel R. Dwyer, Partner, Kleinfeld, Kaplan & Becker, LLP
Mark Mansour, Partner, Foley & Lardner LLP
John M. Packman, Senior Counsel – Food Law, The Coca-Cola Company
Clyde A. Takeguchi, PhD, Executive Vice President, Phoenix Regulatory Associates, LTD

| Daniel G. Schultz, MD, Director, Center for Devices and Radiological Health, FDA
Elaine C. Messa, Vice President –
Medical Devices / Quality Systems, Quintiles, moderator
Suzan Onel, Partner, Kirkpatrick & Lockhart Preston Gates Ellis LLP
Anthony Vale, Partner, Pepper Hamilton LLP
Andrew M. Whitman, Medical Imaging & Technology Alliance, National Electrical Manufacturers Association

| Jesse L. Goodman, MD, MPH, Director, Center for Biologics Evaluation and Research, FDA
Gregory M. Torre, PhD, Vice President, Pharmaceuticals & Biotechnology, The Weinberg Group, moderator
Lisa Barclay, Associate, Zuckerman Spaeder LLP
Glenn N. Byrd, Director, Regulatory Affairs,  MedImmune, Inc.
Jill B. Deal, Partner, Venable LLP

| Bernadette M. Dunham, DVM, PhD, Director, Center for Veterinary Medicine, FDA
Robert B. Nicholas, Capital Partner, McDermott Will & Emory, moderator
David P. Jones, Senior Legal Counsel, Intervet, a part of Schering-Plough Corporation
S. Lee Whaley, Senior Regulatory Affairs Manager, Novartis Animal Health

Lunch with Speaker
Justice Antonin Scalia, Supreme Court of the United States of America