Moderators
Christopher L. Hagenbush, Partner, Patton Boggs LLP
Laurence J. Lasoff, Partner, Kelley Drye & Warren LLP
Mark Mansour, Partner, Bryan Cave LLP
Steven M. Niedelman, Consultant
Alexander H. Schaefer, Counsel, Crowell Moring LLP

Speakers
Deborah M. Autor, JD, Director, Office of Compliance, Center for Drug Research
and Evaluation, FDA
Ann V. Booth-Barbarin, Senior Counsel & Assistant Secretary, AstraZeneca Pharmaceuticals LP
Nicholas Buhay, Deputy Director, Division of Manufacturing & Product Quality,Office of Compliance, CDER, FDA
Rebecca Burkholder, JD, Vice President of Health Policy, National Consumers League
Ellen Y. Chung, Attorney at Law, Hogan & Hartson, L.L.P.
Scott Faber, Vice President, Government Affairs, GMA
Andrew C. Fish, Senior Vice President for Legal and Government Affairs and General Counsel, Consumer Healthcare Products Association
Carl R. Nielsen, Consultant, C. Nielsen Consulting, LLC
Gale Prince, Consultant, Sage Food Consulting
Marianne Rowden, General Counsel, American Association of Exporters and Importers
Cathy Sauceda, Director, Import Safety and Interagency Requirements, Customs and Border Protection, U.S. Department of Homeland Security
Jeffrey E. Shuren, MD, JD, Associate Commissioner for Policy and Planning, Office of the Commissioner, FDA
Debbie R. Subera-Wiggin, Policy Analyst, International Affairs Staff, Office of the Center Director, Center for Food Safety and Applied Nutrition, FDA
Domenic J. Veneziano, CDR U.S. Public Health Service, Director, Division of Import Operations & Policy (DIOP), Office of Regional Operations (ORO), Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA)
John E. Verbeten, Director, Operations and Policy Branch, DIOP, ORO, ORA, FDA
Jeffrey Weiss, Senior Director, Technical Barriers to Trade, Office of the U.S. Trade Representative

Program Description
From places around the world to food and medicine cabinets in the U.S. and from Capitol Hill to FDA and industry, the safety of imported products presents numerous challenges.  With the number of pending legislative initiatives, import regulations continue to be an evolving area of food and drug law. This conference will examine FDA's current legal authority over companies that produce, outside the U.S., products ultimately offered for sale here.  The conference will also discuss current FDA approaches and initiatives, such as border controls, foreign inspections and recent import safety initiatives, as well as congressional proposals to expand FDA’s power to police imports more effectively. Finally, the conference will consider the extent to which national and state regulatory systems, international cooperation and private sector collaboration, as discussed by Health and Human Services Secretary Michael O. Leavitt during a recent  Interagency Import Safety Summit, can better facilitate global trade while protecting the health and safety of U.S. consumers.

Who Should Attend?
Regulatory affairs, compliance, governmental affairs, supply chain, risk management and communications personnel, import brokers, consultants and lawyers who work in international trade, international commercial transactions, dispute resolution, outsourcing and compliance with FDA requirements.

Handout Materials
A binder containing speaker presentations and handouts.

Continuing Legal Education (CLE) Credits
Pending state approvals, CLEs will be awarded.

Registration Fees
Early Bird Rate (Received before Friday, September 26, 2008)
$620 FDLI Members
$1,045 Non-members
$445 Academics, 501(c)(3) Nonprofit, Government

Standard Rate (Received after Friday, September 26, 2008)
$720 FDLI Members
$1,120 Non-members
$520 Academics, 501(c)(3) Nonprofit, Government

Special CD Price!
Purchase the CD set for just $85 with your registration. To receive the special price, CDs must be purchased at the time of registration. Offer limited to one CD set per registrant. In order to use this CD, your portable CD player or computer player must be able to support the MP3 format. Shipping & handling charges will apply.

Tax: CD orders shipped to Washington, DC addresses will be charged 5.75% sales tax. Orders to Maryland addresses will be charged 6% sales tax.

Please contact FDLI at (800) 956-6293 or (202) 371-1420, or e-mail comments@fdli.org.

7:30 a.m.                     
Registration and Continental Breakfast

8:15 a.m.                     
FDLI Welcome and Announcements

Opening Remarks by Program Committee Member

I. Fundamentals of Import Regulation

Refreshment Break

II. Impact of Trade Agreements

Lunch

III. Current and Recent Case Studies Involving International Trade

Refreshment Break

IV. Inspection Strategies

V. How can Foreign Firms be held Accountable for FDA Requirements?

Summary of Conference and Take-Aways

5:15 p.m.
Adjournment

Meeting Date(s) October 24, 2008

Hotel Reservations
The Madison Hotel
1177 15th Street, NW
Washington, DC 20005
Phone: 202-862-1600 | 800-424-8577
View Hotel Website

Room Rate
$255 + applicable taxes
Please call the hotel and identify yourself as an FDLI/Food and Drug Law Institute/Import Regulations conference attendee to receive the rate.

Reservation Cut-Off September 23, 2008

Check-in 3 pm
Check-out 12 Noon

Metro Directions
Orange/Blue Line: Take the Orange or the Blue Line to McPherson Square Metro station and exit through the White House exit to McPherson Square Park located at L Street and 15th Street. Cross I Street and walk up 15th Street, cross L Street but continue to walk up 15th Street. The Madison Hotel will be on your right at the intersection of 15th and M Street.

Red Line: Take the Red Line to Farragut North and walk up K Street. Make a left onto 15th and proceed approximately 1.5 blocks to The Madison Hotel, on your right and at the intersection of 15th and M Street.

More Directions