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Bethesda North Marriott Hotel and Conference Center

2018 年 04 月 23 日 1:00 下午 - 2018 年 04 月 23 日 5:00 下午

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

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

概览

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.

学习目标

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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