Module 1 2021

28/06/2021

PMDA Consultation Team

Office Director

Review Director

CMC/Pharmacology/ADME 1~2

Toxicology 1~2

Clinical 1~2

Biostatistician 1~2

Project Management 1

Distribution to third parties is not allowed

29

Presentation Outline

Introduction to Japanese Market

PMDA Scientific Advice

Clinical Trials in Japan vs Europe

Recent Updates & Regulatory Pathways

Cultural Considerations

Distribution to third parties is not allowed

30

15