Pharmaceutical Labeling Summit Presentations

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DAY ONE — Tuesday, Oct. 16, 2012

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.

Downstream Use of SPL

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

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)

Moderator:
Steffen Johnson, Partner, Winston & Strawn

Panelist:
Jim Beck, Counsel, Reed Smith
Brennan Torregrossa, Assistant General Counsel, GlaxoSmithKline
Randall Christian, Partner, Bowman and Brooke

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)

Moderator:
Dr. Stephen Goldman, Managing Member, Stephen A. Goldman Consulting Services, L.L.C.; former Medical Director, MedWatch, FDA

Panelists:
Dr. Michael Klepper, President and Founder, Drug Safety Navigator, LLC
Lori Leskin, Partner, Co-chair, Product Liability Litigation and Counseling, Kaye Scholer LLP