返回 Agenda
Part 1 – Introduction to Clinical Overview and the Product Development Rationale
Session Chair(s)
Diptee A. Gajjar, PHD
Intercontinental Regulatory Strategy Lead
Bristol-Myers Squibb Company, United States
The Role of the Clinical Overview Within the CTD
Important Considerations in Constructing a Clinical Overview
Getting Prepared: Overall Content of Clinical Overview and Sources of Information
Strategies in Developing Section 1: Product Development Rationale