8th DIA Annual Conference in Japan for Asian New Drug Development

Ari Fujishiro

Senior Director, Regulatory Affairs Group, Asia Development Dept., R&D Division

Akio Uemura, PhD

Senior Advisor

An Overview of the FDA GCP Inspection Process and Key Trends

Ann Meeker-O'Connell, MS

FDA, United States

Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC

PMDA's Experiences on Foreign GCP Inspection: Focusing on Asian Region

Tomoko Ohsawa, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Director of Office of Informatics and Management for Safety

MFDS's Perspective of Regulatory Inspection in Korea

Ho Jin Oh, PharmD

Ministry of Food and Drug Safety (MFDS), Korea, Republic of

Assistant Director, Clinical Trials Management Div, Pharmaceutical Safety Bureau

Status of Regulatory Policies and Approval for Pharmaceutical Products in China

Jiangping Dong

National Medical Products Administration (NMPA), China

Director-General, China Center for Food and Drug International Exchange (CCFDIE)