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Bethesda North Marriott Hotel and Conference Center

Apr 23, 2018 1:00 PM - Apr 23, 2018 5:00 PM

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

Course 2: Writing Good Core Data Sheets and Supporting Documentation – Performing Rational Deviation Management

Overview

Short Course Registration: 12:00-5:00PM

This short course discusses common shortfalls of Company Core Data Sheet (CCDS) content and supporting rationales/documentation that have implications for regulatory acceptability of proposed safety labeling changes. Improvement strategies are presented and evaluated in interactive practice exercises. In addition, the short course explores rational strategies for accepting or refuting local labeling deviations from Company Core Safety Information (CCSI) content.

Return to Global Labeling Conference.

Learning objectives

At the conclusion of this short course, participants should be able to:

Describe common shortfalls of CCDS content and supporting rationales/documentation
Explain why these shortfalls limit regulatory acceptability of proposed safety labeling changes
Discuss ways to improve CCDS content and supporting rationales/documentation
Explain when proposed local labeling or CCSI content may have to be changed to ensure sufficient similarity

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Course 2: Writing Good Core Data Sheets and Supporting Documentation – Performing Rational Deviation Management

Overview

Learning objectives

Be informed and stay engaged.