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[Session 3] Chance of Collaboration among Asian Health Authorities – GCP & AMR
Session Chair(s)
Hiroshi Watanabe, MD, PhD
Vice President, Hamamatsu University School of Medicine, Japan
As with globalization of drug development, collaboration among national and regional regulatory agencies has grown more important. Recent regulatory activities to this end include the GCP inspections to ensure reliability of clinical study results conducted for new drug application around the world, and a multilateral approach to the current global problem of drug-resistant bacteria. This session will introduce recent trend of the GCP inspections and efforts to promote the clinical development of antibiotics for antimicrobial resistance (AMR) and the potential of collaboration among regulators in Asia in this area.
Speaker(s)
Hiroshi Doguchi, DVM, PhD
GCP Inspector, Office of Non-Clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
GCP Inspection in Japan
Lien-Cheng Chang, PhD
Senior Secretary, Department of Intellectual Property and Technology Transfer, Academia Sinica, Taiwan
TFDA GCP Inspection
Cathy LIU, MBA
Staff, Fortrea, China
An Industry Perspective on CFDI GCP Inspection
Jung Eun Jo
Clinical Trials Management Division, Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety, Korea, Republic of
GCP Inspection under MFDS (tentative)
Junko Sato, PhD
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Regulator’s Challenge to Combat AMR
Antonio Fredelindo Dela Resma Villanueva, MD
Project Manager, Department of International Trial, Center for Clinical Sciences, National Center for Global Health and Medicine (NCGM), Japan
The AMR Projects
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