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Online

Feb 21, 2017 11:30 AM - Feb 23, 2017 1:30 PM

Art of Writing a Clinical Overview

Back to Agenda

Part 3 – Preparing the Benefit-Risk Assessment and Best Practices for Clinical Overview Construction

Session Chair(s)

Diptee A. Gajjar, PhD

Diptee A. Gajjar, PhD

Intercontinental Regulatory Strategy Lead

Bristol-Myers Squibb Company, United States

  • Session 7: Continued:
    Strategies in Developing Section 5, Overview of Safety

  • Exercise

  • Session 8:
    Strategies in Developing Section 6, Benefits and Risks Conclusions

  • Session 9:
    Best Practices for Developing a Submission-ready Clinical Overview

  • Session 10:
    Other Clinical Overview Scenarios

  • Questions and Answers

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