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Online

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

Art of Writing a Clinical Overview

Part 1 – Introduction to Clinical Overview and the Product Development Rationale

Session Chair(s)

Diptee A. Gajjar, PhD

Diptee A. Gajjar, PhD

Intercontinental Regulatory Strategy Lead

Bristol-Myers Squibb Company, United States

  • Welcome and Introduction

  • Session 1:
    The Role of the Clinical Overview Within the CTD

  • Session 2:
    Important Considerations in Constructing a Clinical Overview

  • Session 3:
    Getting Prepared: Overall Content of Clinical Overview and Sources of Information

  • Session 4:
    Strategies in Developing Section 1: Product Development Rationale

  • Questions and Answers

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