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Tips, Tools, and Templates: Developing Brief Summaries, Major Statements and Important Safety Information
Session Chair(s)
Mark Gaydos
Head of Labeling and Advertising & Promotion, Global Regulatory Science
Moderna, United States
Victoria Tamarkin, MS
Founding Partner & President, Global Regulatory Affairs, Promotional Compliance
Victoria Tamarkin Consulting LLC, United States
This session will provide practical suggestions for the development and implementation of documents that are critical to the adequate and timely communication of product risk information. Presenters will cover brief summaries used in print advertising, consumer brief summaries used in DTC advertising and promotional labeling, major statements included in DTC TV ads and both consumer and professional important safety information (ISI) integrated within promotional labeling.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify critical documents that must be created or updated to ensure appropriate and timely product risk communication
- Identify functional partners critical to the timely creation or updating of these documents
- Apply practical and efficient strategies to ensure documents that communicate risk information are created and updated in an expeditious manner
Speaker(s)
Speaker
Kevin Gomba
Otsuka, United States
Associate Director, Global Regulatory Affairs, Promotion Compliance