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Bethesda North Marriott Hotel and Conference Center

Mar 03, 2016 7:30 AM - Mar 04, 2016 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Marketing Pharmaceuticals 2016

Discuss the complexity of marketing and how to promote pharmaceuticals, biologics, and medical devices in an effective yet compliant manner in an evolving environment.

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Session 4A: Safety Labeling Changes - Real-World Execution Into Packaging, Advertising and Promotion, and Beyond

Session Chair(s)

Sandra Kerr, RPh

Executive Director, Office of Promotion and Advertising Review

Merck & Co., Inc., United States

The Food and Drug Administration Amendments Act (FDAAA) of 2007 authorizes FDA to require labeling changes when it becomes aware of new safety information it believes should be included in the labeling of an approved drug product. However, neither the statute nor the draft guidance include specific deadlines or timeframes for how quickly the revised labeling must be incorporated into the packaging of the product or into other labeling such as promotional labeling. Sponsor initiated safety changes such as Changes Being Effected (CBE) supplements have no mandatory timeframes for review and/or action by the agency or timelines for implementation. This session will review the regulations, guidance, and proposed rules related to implementing safety labeling changes. It will also give you the opportunity to work through case studies with others in industry and discuss best practices and considerations for successful implementation of revised labeling.

Speaker(s)

Facilitators

Kimberly Belsky, MS

Independent, United States

Reg Policy & Intell and AdPromo, Regulatory Affairs

Dolores Shank-Samiec, MS

Merck, United States

Retiring as of 3/5/2021

Kelly Treonze, MS

Merck & Co., Inc., United States

Head, Global Labeling Strategy

Nicole Smith, MPH

Amgen, United States

Director, Regualtory Promotion Group

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