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FDAnews announces Third Annual Pharmaceutical Labeling Summit

FALLS CHURCH, Va., Sept. 19, 2012 /PRNewswire-iReach/ -- Third Annual Pharmaceutical Labeling Summit:


**Presented by  FDAnews**

Oct. 16-17, 2012 – Bethesda, MD


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, Project Manager, FDA Data Standards Council, CDER
  • Denise Esposito, Deputy Director, Office of Regulatory Policy, CDER, FDA (invited)
  • Dr. Mark Collins, Director, Pharmacovigilance and Risk Management, Endo Pharmaceuticals
  • Virginia Hogan, Associate Director, Labeling, Teva Pharmaceuticals
  • Steffen Johnson, Partner, Winston & Strawn
  • Dr. Michael Ryan, Department of Psychology, The University of Texas at San Antonio
  • Jim Beck, Partner, Reed Smith
  • Mona Desai, Manager, Labeling, Regulatory Affairs, Interchem
  • Randall Christian, Partner, Bowman and Brooke

Who Should Attend:

  • 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

Register today

Tuesday, October 16, 2012
8:00 a.m. – 9:00 a.m.  Registration and Continental Breakfast
9:00 a.m. – 9:15 a.m.  Chair Welcome and Introduction
9:15 a.m. – 10:00 a.m.  FDA's Expectations for Compliant Labeling in 2013 and Beyond
10:00 a.m. – 10:45 a.m.  Accessing Package Insert (Content of Labeling) Information Via Mobile Devices
10:45 a.m. – 11:00 a.m.  Morning Break
11:00 a.m. – 12:00 p.m.  Panel Discussion:  Examination of How the FDA Applies Black Box Warnings Within a Drug Class
12:00 p.m. – 1:30 p.m.  Lunch Break
1:30 p.m. – 1:45 p.m.  Recap of Morning Sessions
1:45 p.m. – 2:30 p.m.  SPL Update and Downstream Use of SPL
2:30 p.m. – 3:15 p.m.  ANDA Labeling — Current Status of the FDA's Labeling Review and Approval Process
3:15 p.m. – 3:30 p.m.  Afternoon Break
3:30 p.m. – 4:15 p.m.  Do Drug Product Labels Confirm and Correct Consumers' Medication Preconceptions?
4:15 p.m. – 5:00 p.m.  The Impact of Labeling on Advertising and Promotion
5:00 – 7:00 p.m.  Cocktail Reception and Networking
Wednesday, October 17, 2012
8:00 a.m. – 9:00 a.m.  Registration and Continental Breakfast
9:00 a.m. – 9:15 a.m.  Chair Welcome and Introduction
9:15 a.m. – 10:00 a.m.  The Tipping Point of FDA's Public Health Voice: Has the Proliferation of Warnings Diminished the Agency's Impact on Clinical Practice
10:00 a.m. – 12:30 p.m.  Panel Discussion:  Pilva v. Mensing Redux?  What Does the First Circuit Court of Appeals Decision in Barlett v. Mutual Mean for Generic Preemption?
12:30 p.m. – 1:30 p.m.  Lunch Break
1:30 p.m. – 4:00 p.m.  Panel Discussion:  Determining Threshold and Causality When Considering Label Updates — How Safety Signals, REMS and Pharmacovigilance Are Influencing Labeling Decisions
4:00 p.m. – 4:15 p.m.  Day Two Adjourn, Closing Remarks

Third Annual Pharmaceutical Labeling Summit
**Presented by  FDAnews**
Oct. 16-17, 2012 – Bethesda, MD

Early Bird (Must register by Sept. 21, 2012): $1,797 per attendee 
Regular Tuition (Sept. 22-Oct. 17, 2012): $1,997 per attendee

4 Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600
Fax:          703-538-7676
Mail to:     FDAnews
300 N Washington St
Ste 200
Fall Church, VA 22046-3431

Media Contact: Jeff Grizzel FDAnews, 703-538-7668,

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