Pharmaceutical Labeling Summit Presentations
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DAY ONE — Tuesday, Oct. 16, 2012 |
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9:15 a.m. – 10:15 a.m. |
Examination of How the FDA Applies Boxed Warnings Dr. Stephen Goldman, Managing Member, Stephen A. Goldman Consulting Services, L.L.C.; former Medical Director, MedWatch, FDA |
10:35 a.m. – 11:45 a.m. |
Accessing Package Insert (Content of Labeling) Information Via Mobile Devices Lonnie Smith, Policy Analyst, FDA Data Standards Council, OC, FDA |
1:15 p.m. – 2:00 p.m. |
Mona Desai, Manager, Labeling, Regulatory Affairs, Interchem Corporation |
2:00 p.m. – 2:45 p.m. |
ANDA Labeling — Current Status of the FDA’s Labeling Review and Approval Process (Only hard copies available) Diane Servello, Senior Director, Regulatory Affairs, Mallinckrodt (a Covidien Company) |
3:05 p.m. – 3:55 p.m. |
Do Drug Product Labels Confirm and Correct Consumers' Medication Preconceptions? Dr. Michael Ryan, Associate Professor, Department of Psychology, The University of Texas at San Antonio |
3:55 p.m. – 4:45 p.m. |
The Impact of Labeling on Advertising and Promotion Becky Cleavenger, Senior Director, Global Regulatory Affairs, Baxter Healthcare |
DAY TWO — Wednesday, Oct. 17, 2012 |
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9:15 a.m. – 10:15 a.m. |
The Role of Labeling in REMS: Examples from the Opioid and Other REMS Dr. Mark Collins, Director, Pharmacovigilance and Risk Management, Endo |
10:30 a.m. – 12:45 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? (No slides for this session)
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1:45 a.m. – 4:15 p.m. |
Panel Discussion: Determining Threshold and Causality When Considering Label Updates — How Safety Signals, REMS and Pharmacovigilance Are Influencing Labeling Decisions (No slides for this session)
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