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#273: Regulatory Cooperation Between US and Japan
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
Salon B
Component Type: Forum
Level: Intermediate

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Washington, DC Office in November, 2024 for one of the purposes of strengthening regulatory cooperation between US and Japan. After the establishment of the Office, direct communication and practical cooperation at DC time make possible, and it is also possible to make the foundation of regulatory cooperation. This session will explore the purpose behind the establishment of PMDA’s Washington, DC Office and its role in strengthening U.S.-Japan regulatory cooperation. Representatives from PMDA and FDA will share their perspectives on collaborative opportunities, followed by a panel discussion on how this initiative can enhance global regulatory alignment and communication.

Learning Objectives

Analyze the strategic purpose behind the establishment of PMDA’s Washington, DC Office and evaluate its role in enhancing regulatory cooperation between the US and Japan; Engage in a panel discussion to identify and propose opportunities for collaborative initiatives between PMDA and FDA that support global regulatory alignment and improved international communication.

Chair

Naoyuki Yasuda, MSc

Speaker

Panelist
Richard Pazdur, MD

Panelist
Akihiro Ishiguro, PhD

Panelist
Mark Abdoo

Panelist
Yasuhiro Fujiwara, MD, PhD


Speakers
avatar for Naoyuki Yasuda

Naoyuki Yasuda

Pharmaceuticals and Medical Devices Agency, Japan
Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →
avatar for Akihiro Ishiguro

Akihiro Ishiguro

Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management... Read More →
avatar for Mark Abdoo

Mark Abdoo

Associate Commissioner for Global Policy and Strategy, FDA, United States
avatar for Richard Pazdur

Richard Pazdur

Director, Oncology Center of Excellence, CDER, FDA, United States
Richard Pazdur, M.D., is the director of the FDA’s Oncology Center of Excellence (OCE), which leverages the combined skills of FDA’s regulatory scientists and reviewers with expertise in drugs, biologics, and devices to expedite the development of novel cancer products. In this... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
Salon B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

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