Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations?
William Gregory, PhD
Safety and Risk Management
Pfizer Inc, United States
to be determined
Learning Objective : 1. Describe the requirements for pre-market safety reporting in the U.S.
2. Describe the similarities and differences in global regulatory requirements for pre-market safety reporting
3. Recognize the value of streamlining the reporting process, including the creation of a global safety database
Safety Reporting Practices: Current State, Efforts to Streamline the Process, and the Case for a Global Safety Database
FDA, United States
Emerging New PV World: Comparison of and Exploring New Guidelines for Clinical Research in Japan
Teiki Iwaoka, PhD, MS
Executive Consultant, Director of Drug Safety Outsourcing Planning
CAC Croit Corporation, Japan