Third Annual Pharmaceutical Labeling Summit Accuracy, Balance and Brevity — Labeling’s Role in Safety and Efficacy
Product Details
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:
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Early Bird Fee
Before Oct. 5, 2012 |
Regular Fee
Oct. 6 – Oct. 17, 2012 |
Executive Briefing
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$1,797
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$1,997
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Send Your Team for Maximum Benefit
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 |