Speakers

Afia K. Asamoah, JD, MPP, Special Assistant to the Principal Deputy Commissioner, FDA
Frederick H. Branding, RPh, JD, Principal Attorney, Olsson Frank Weeda Terman Bode Matz PC
Benjamin L. England, President/CEO, FDAImports.com, LLC
Melanie M. Fairchild-Dzanis, Consultant
Steven A. Johnson, FDA Legal Expert, Compliance Officer
Maurice A. Leiter, Partner, Arnold & Porter LLP
Elaine C. Messa, RAC, Director, Medical Device Quality Systems and Compliance,
Becker & Associates Consulting, Inc.
Robert I. Roth, MD, PhD, Medical Director, The Weinberg Group Inc.
Kevin Underhill, Partner, Shook, Hardy & Bacon L.L.P.
Daron Watts, Partner, Sidley Austin LLP
James M. Wood, Partner, Reed Smith

Program Description

What are the most pressing and emerging issues in food and drug law and regulation? FDLI has partnered with the Orange County Regulatory Affairs (OCRA) to present an interactive program designed to provide intermediate-advanced level regulatory affairs and legal professions with discussions and insights on the changes to the Food and Drug Administration's (FDA's) enforcement approach, risk management, a 510(k)s update and implications, FDA/Federal Trade Commission (FTC) claims jurisdiction, international issues, adverse events reporting and FDA's Transparency Initiative. This program addresses developments across the industries regulated by FDA by engaging in discussions and debate about relevant issues that impact your work as a food and drug law and regulation professional.

Who Should Attend?

Intermediate-advanced level learners practicing in food and drug law and regulation.

Handout materials

Binder of speakers' materials

Continuing Legal Education (CLE) Credits

Continuing Legal Education credits are available after attending this program. FDLI applies directly to Ohio, Pennsylvania and Virginia. These states are generally recognized as approved jurisdictions by other states. Please contact your Bar Association for guidance.

CLE credits for Advanced Topics in Food and Drug Law and Regulation
have been approved for the following:

Virginia = 7 credits

Registration Fees

$ 790 FDLI and OCRA Member *
$1,220 Non-Member

$ 575 Government Member
$ 675 Government Non-Member

$ 575 Academic Member
$ 675 Academic Non-Member

$ 790 Sole Practitioner Member
$1,220 Sole Practitioner Non-Member

$ 225 Student Member
$ 300 Student Non-Member
(Please call FDLI's Customer Service at (202) 371-1420 to receive this rate)

* OCRA Members who are not FDLI Members must call FDLI's Customer Service at (202) 371-1420 to obtain Member pricing.

Please contact Customer Service at (800) 956-6293 or (202) 371-1420, or by e-mail at service@fdli.org,
if you have any questions about your conference registration.

Conference Registration Policies

7:30 a.m.                       
Registration and Continental Breakfast

8:30 a.m.                       
FDLI and OCRA Welcome and Announcements
                                   
8:40-8:45 a.m.                       
I. Introduction and Overview
                                                           
8:45-10:15 a.m.                       
II. Changes in FDA's Enforcement Approach: Impact on the Regulated Industries
Since FDA Commissioner Hamburg's Enforcement Priorities were announced in August 2009, it has been predicted there will be an increase in the number of prosecutions of individuals for violations of the Federal Food, Drug and Cosmetic Act, the statute that governs manufacture and distribution of FDA-regulated products. Recent FDA enforcement actions are supporting the prediction. What will FDA's stepped up enforcement activities mean for the regulated industries? What effective policies and procedures that prevent violations from occurring should the industries implement?

10:15-10:30 a.m.           
Refreshment Break

10:30 a.m.-12 Noon           
III. Safety and Risk Management
Obtain an update on the safety and risk management initiatives and trends across the FDA-regulated industries. This session will explore how safety and risk are part of product, compliance and life cycle planning.

12 Noon- 1:15 p.m.           
Lunch with speaker: Emerging Technologies in the FDA-Regulated Industries

1:15-2:00 p.m.                       
IV. 510(k)s Update and Potential Implications
The 510(k) process has been under closer public scrutiny for allowing medical devices through, that some argue, should have been subject to more FDA review. In August, FDA released a list of preliminary proposals to modify the 510(k) process; the agency expects to release a plan for implementing the changes later this year. Recently, lawmakers asked FDA Commissioner Hamburg to provide further insight into the proposed changes for the 510(k) review process and to delay some of the more controversial proposals. Lawmakers and medical device companies have expressed concern that some of FDA's recommendations could affect getting products to market and impact innovation and competition. This session will provide an update on the status of the 510(k) process, the public health concerns that initiated higher scrutiny while considering the implications that changes will have on FDA reviews and getting product to market.

2:00-2:45 p.m.                       
V. What is the "Scope of Order" Authority?  Claims and FDA and FTC Jurisdiction/Roles
(POM Wonderful among others)

2:45-3:00 p.m.                       
Refreshment Break

3:00-3:45 p.m.
VI. International and Import Activities
The United States markets are increasingly populated with variety of imported consumer goods. Based on the volume of imported products from specific areas of the world, problems have been associated with some consumer products over the years. Because FDA regulates a large number of these products and is responsible for ensuring that they meet US standards for safety and quality and do not jeopardize the public health or national security, FDA has identified China, India, the Middle East, Europe, and Latin America as areas in which to establish international posts. Is FDA's enhanced international presence and inspections activities lessening the number of product problems?

           1. FDA Foreign Inspection Programs - What to Expect Next
           2. FDA Foreign Offices: What in the World is FDA doing?
           3. FDA Import Activities - Increased Inspections/Enforcement at the Border

3:45-4:30 p.m.                       
VII. What Adverse Events Reportings (AERs) Really Are –
and they Involve More than Just Approved Products in the United States
The session will provide an overview of FDA's requirements for AERS as well as a discussion of best practices for monitoring, reporting, and acting on AERS and trends. The speakers will discuss the statutory and regulatory requirements for AERS, resources available, and proactive plans for them. Additionally, there will be an update on the electronic reporting of AERS - the advantages, disadvantages and technical issues.

4:30 p.m.                       
VIII. FDA’s Transparency Initiative Update

5:30/6:00 p.m.                       
Closing Remarks and Adjournment

Westin South Coast Plaza Hotel
686 Anton Boulevard
Costa Mesa, CA 92626
Phone: (714) 540-2500
Fax: (714) 662-6695
Visit the hotel's website

Room Rate
$ 179 single/double plus prevailing taxes
$ 209 triple/quad plus prevailing taxes

Make Your Room Reservation Online Now
www.starwoodmeeting.com/Book/FDLI

Or call the hotel and identify yourself as an FDLI/Food and Drug Law Institute/Advanced Topics conference attendee to receive the rate.

Reservation Cut-Off October 15, 2010

Directions

Please visit the directions page on the hotel's website for more information.