Planning Committee
Jeffrey E. Fetterman, President and CEO, ParagonRx
Roger Morris, Principal, Marketing and Communications Consulting, The LondonBritain Company
Wayne L. Pines, President, Regulatory Services and Healthcare, APCO Worldwide

Moderators
Howard L. Dorfman, Senior Counsel, Ropes & Gray, LLP
Daniel A. Kracov, Partner and Chair of FDA and Health Practice, Arnold & Porter LLP
Scott M. Lassman, Partner, Wilmer Hale, LLP
Meredith Manning, Partner, Hogan & Hartson, LLP

Panel Members
Janice K. Bush, MD, Vice President, Benefit Risk Management/Translational Pharmacovigilance, Johnson & Johnson Pharmaceutical Group
Gerald J. Dal Pan, MD, MHS, Director, Office of Surveillance and
Epidemiology, CDER, FDA
Debra S. Dunne, RPh, Partner, Stradley Ronon Stevens & Young LLP
Kelly A. Falconer, Corporate Counsel, Pfizer, Inc.
Kimberly P. France, Director, Covidien
Rekha Garg, MD, MS, Executive Director, Risk Intervention Strategy & Communication, Global Regulatory Affairs and Safety, Amgen Inc.
Claudia B. Karwoski, PharmD, Director, Division of  Risk Management, Office of Surveillance and Epidemiology, CDER, FDA
Michael Klein, PhD, Director, Controlled Substance Staff, Office of the Center Director, CDER, FDA
Deborah B. Leiderman, MD, Consulting Neurologist, CNS Drug Consulting LLC
Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius, LLP
Gary H. Slatko, MD, MBA, Chief Medical Officer, Paragon Rx
Annette Stemhagen, DrPH, FISPE, Vice President, Epidemiology & Risk Management, United BioSource Corporation

Program Description
The enactment of REMS -- Risk Evaluation and Mitigation Strategy -- has changed the world of drug development and product marketing. Pharmaceutical and biotechnology companies who don't thoroughly understand the strategies and tactics of REMS do so at their own peril.  At this conference, the authors of FDLI’s book, Pharmaceutical Risk Management: Practical Applications, and other experts in the field will provide a day of theoretical and practical enlightenment while engaging the audience to become part of the discussion.

The conference is especially important for product marketing executives and regulatory affairs, legal, medical affairs, and late-stage R&D team members.

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, December 12, 2008)
$620 FDLI Members
$1,045 Non-members
$445 Academics & Government

Standard Rate (Received after Friday, December 12, 2008)
$720 FDLI Members
$1,120 Non-members
$520 Academics & 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.

Conference Registration Policy  

7:30 am                       
Registration and Continental Breakfast

8:15 am                       
FDLI Welcome

I. Introduction and Overview of Meeting
Wayne L. Pines, President, Regulatory Services and Healthcare, APCO Worldwide

II. A Perspective on REMS and Risk Management
          A. Overview of the New REMS Requirement
          B. History of Risk Management at FDA
          C. Establishing a Framework for Risk Management
                   Moderator:
                   Meredith Manning, Partner, Hogan & Hartson, LLP
                   Panel Members:
                   Debra S. Dunne, RPh, Partner, Stradley Ronon Stevens & Young LLP
                   Deborah B. Leiderman, MD, Consulting Neurologist, CNS Drug
                   Consulting LLC
                   Adrian Thomas, MD, FRACP, Chief Safety Officer & Global Head Benefit
                   Risk Management, Johnson & Johnson Pharmaceutical Group

Refreshment Break

III. FDA Implementation of REMS
          Moderator:
          Daniel A. Kracov, Partner and Chair of FDA and Health Practice,
          Arnold & Porter LLP
          Panel Members:
          Gerald J. Dal Pan, MD, MHS, Director, Office of Surveillance and
          Epidemiology, CDER
          Claudia B. Karwoski, PharmD, Director, Division of Risk Management,
          Office of Surveillance and Epidemiology CDER, FDA
          Michael Klein, PhD, Director, Controlled Substance Staff, Office of the Center
          Director, CDER, FDA
          Kathleen M. Sanzo, Partner, Morgan Lewis & Bockius, LLP

12:00-1:30 pm            
Lunch
What Companies Are Doing (or Need to Do) to Comply with REMS.
An Open Mike Session moderated by Wayne Pines

1:30 pm                       
IV. Navigating a REMS Program Through FDA
          A. Risk Assessment
          B. Drafting the Plan
          C. Submitting to FDA
          D. Negotiating with FDA
          E. Evaluating the Plan
                   Moderator:
                   Scott M. Lassman, Partner, Wilmer Hale, LLP
                   Panel Members:
                   Annette Stemhagen, DrPH, FISPE, Vice President, Epidemiology & Risk
                   Management, United BioSource Corporation
                   Gary H. Slatko, MD, MBA, Chief Medical Officer, Paragon Rx

Refreshment Break

V. The Deep Dive into Specific REMS Programs: Chantix, Nplate, etc.
          Moderator:
          Howard L. Dorfman, Senior Counsel, Ropes & Gray, LLP
          Panel Members:
          Kelly A. Falconer, Corporate Counsel, Pfizer, Inc.
          Kimberly P. France, Director, Covidien
          Rekha Garg, MD, MS, Executive Director, Risk Intervention Strategy
          & Communication, Global Regulatory Affairs and Safety, Amgen Inc.

4:45 pm                       
Closing Remarks and Adjournment

Meeting Date(s) January 13, 2009

Meeting Location
The Law Offices of Morgan, Lewis & Bockius, LLP
1111 Pennsylvania Avenue, NW
Washington, DC 20004
Phone: 202-739-3000

The meeting location is approximately 3 blocks from the Grand Hyatt Hotel. Check in with the security desk and proceed to the 2nd floor.

Hotel Reservations (sleeping rooms only)
Grand Hyatt Hotel
1000 H Street, NW
Washington, DC 20001
Phone: 202-582-1234   
Fax: 202-637-4781

Room Rate
$239 single/double + applicable taxes. Identify yourself as being with the Food and Drug Law Institute/FDLI

Valet parking for overnight guests is $30.00/day and $20.00 for self parking guests.

Reservation Cut-Off December 12, 2008

Check-in 3 pm
Check-out 11 am

Directions to the meeting location:
Federal Triangle Metro Stop (blue, orange lines):
From station, exit on 12th Street and follow north 1 block to intersection of 12th and Pennsylvania Ave. Turn right onto Pennsylvania Ave. Follow one half block east to 1111 Pennsylvania on left.

Metro Center Metro Stop (blue, orange, red lines):
Exit station at F & 12th Streets. Follow 12th Street south two blocks to Pennsylvania Ave. Turn left (east) to 1111 Pennsylvania Ave.

Archives/Navy Memorial/Penn Quarter Metro Stop (yellow/green lines):
Exit station at 7th and Pennsylvania Ave. Follow Pennsylvania (west) three blocks to 1111 Pennsylvania Ave.

Public parking near Morgan Lewis is at the 11th Street and Pennsylvania Avenue garage.  Cost is $20.00