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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)
GCP Inspection in Japan
Hiroshi Doguchi, DVM, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
GCP Inspector, Office of Non-Clinical and Clinical Compliance
TFDA GCP Inspection
Lien-Cheng Chang, PhD
Academia Sinica, Taiwan
Senior Secretary, Department of Intellectual Property and Technology Transfer
An Industry Perspective on CFDI GCP Inspection
Cathy LIU, MBA
Fortrea, China
Staff
GCP Inspection under MFDS (tentative)
Jung Eun Jo
Ministry of Food and Drug Safety, Korea, Republic of
Clinical Trials Management Division, Pharmaceutical Safety Bureau
Regulator’s Challenge to Combat AMR
Junko Sato, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
The AMR Projects
Antonio Fredelindo Dela Resma Villanueva, MD
National Center for Global Health and Medicine (NCGM), Japan
Project Manager, Department of International Trial, Center for Clinical Sciences
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