Introduction

Abstract

Many pharmaceutical companies are promoting the simultaneous global development of innovative new drugs, and the number of FIH studies has increased in Japan. Therefore, it is crucial for both sponsors and regulators to communicate with each other, and fully discuss the risks and benefits of individual products from a scientific point of view. In this workshop, all participants, including the audience, will be able to exchange opinions through a questionnaire survey, case studies, and panel discussions, and to promote a mutual better understanding of the non-clinical safety assessment.