In clinical development, safety profile of the candidate pharmaceutical/biological product became more and more important, given that there is more likely an existing treatment for the target disease on the market and the potential target population growth. Accordingly, development of statistical methods that can be applied for safety analyses have drawn much attention lately. In this session, industry and regulatory agency speakers will discuss the new developments in this important area.

Learning Objectives:
Discuss the available approaches to analyzing an integrated summary of safety data.