Third Annual Pharmaceutical Labeling Summit Accuracy, Balance and Brevity — Labeling’s Role in Safety and Efficacy

$1,797.00

 
 
 

Labeling remains one of the most intense negotiations that industry has with the FDA — whether it’s the battle of getting a label approved or conflicts over postmarket revisions.

Join an elite group of drug and biologic industry executives, FDA officials, industry attorneys and thought leaders to discuss and debate the future and implications of the ongoing tug-of-war that is pharmaceutical labeling and revision.

2012 Highlighted Speakers Include:

  • Carla Cartwright, Associate Chief Counsel, Office of the Chief Counsel, FDA (invited)
  • Lonnie Smith, Policy Analyst, FDA Data Standards Council, OC, FDA
  • Denise Esposito, Deputy Director, Office of Regulatory Policy, CDER, FDA (invited)
  • Dr. Mark Collins, Director, Pharmacovigilance and Risk Management, Endo Pharmaceuticals
  • Steffen Johnson, Partner, Winston & Strawn
  • Dr. Michael Ryan, Department of Psychology, The University of Texas at San Antonio
  • Jim Beck, Partner, Reed Smith
  • Brennan Torregrossa, Assistant General Counsel, GlaxoSmithKline
  • Mona Desai, Manager, Labeling, Regulatory Affairs, Interchem
  • Randall Christian, Partner, Bowman and Brooke
  • Dr. Stephen Goldman, Managing Member, Stephen A. Goldman Consulting Services, L.L.C.; former Medical Director, MedWatch, FDA
  • Diane Servello, Senior Director, Regulatory Affairs, Mallinckrodt (a Covidien Company)
  • Becky Cleavenger, Senior Director, Global Advertising and Promotion Center of Excellence, Baxter Healthcare
  • Dr. Michael Klepper, President and Founder, Drug Safety Navigator, LLC

  • VP/Director Global Labeling 
  • Global Regulatory Affairs
  • Promotional Regulatory Affairs
  • Regulatory Affairs Labeling
  • Labeling and Product Communications
  • Scientist, Regulatory Affairs
  • Chief Regulatory Counsel
  • Chief Medical Officer
  • VP/Director Global Patient Safety
  • Corporate Counsel
  • Outside Counsel

For 2012 exhibit options and sponsorship packages contact Colette McMullen, Director, Business Development at (703) 538-7642 or cmcmullen@fdanews.com

The National Press Club
529 14th Street, NW
Washington, DC 20045
Tel: +1 (202) 662-7500
www.press.org

Register for 2012:

 
Early Bird Fee
Before Oct. 5, 2012
Regular Fee
Oct. 6 – Oct. 17, 2012
Executive Briefing
$1,797
$1,997

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2-4 attendees – 10%
7-9 attendees – 20%
5-6 attendees – 15%
10+ attendees – 25%

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Cancellations and Substitutions

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.