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#415: Regulatory Cooperation Between the United States and Japan
Monday June 15, 2026 11:00am - 12:15pm EDT
115C
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-522-L04-P; CME 1.25; RN 1.25

This session provides an update on the current regulatory affairs between FDA and PMDA. Both agencies will highlight significant regulatory collaboration in two areas, oncology and drug safety and discuss future regulatory activities in their region.

Learning Objectives

Describe the latest regulatory collaboration between the United States and Japan; Identify new key areas for further regulatory collaboration between FDA and PMDA.

Chair

Sema Hashemi, MS

Speaker

Panelist
Mark Abdoo

Panelist
Naoyuki Yasuda, MSC

Panelist
Gerald Dal Pan, MD, MHS

Panelist
Miki Ota, MPHARM

Panelist
Akihiro Ishiguro, PHD


Speakers
avatar for Mark Abdoo

Mark Abdoo

Associate Commissioner for Global Policy and Strategy, FDA, United States
avatar for Sema Hashemi

Sema Hashemi

Senior International Policy Advisor, FDA, United States
Ms. Sema Hashemi is a Senior International Policy Advisor in the Office of Global Policy and Strategy (OGPS) within FDA’s Office of the Commissioner. Her portfolio focuses on bilateral and regional engagements with Canada, East Asia, the Pacific, Middle East and North Africa. Sema... 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 Miki Ota

Miki Ota

Director, Office of Informatic and Manegement for Safety, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Ms. Miki Ota joined the MHLW in December 2000, when she was assigned to the Pharmaceutical and Food Safety Bureau. She was mainly involved in Safety measure of Chemical Substance. Subsequently, she worked in several organizations including Ministry of the Environment, National Personnel... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
avatar for Naoyuki Yasuda

Naoyuki Yasuda

Pharmaceuticals and Medical Devices Agency (PMDA), 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 →
Monday June 15, 2026 11:00am - 12:15pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Forum

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