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Monday, June 17 • 11:00am - 12:00pm
#109: GCP Renovation: How Will GCP Inspection Change in Europe, Japan, and the US?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-523-L04-P; CME 1.00; RN 1.00

In this session, we will invite speakers from EMA, FDA, and PMDA, and share the latest regulations, perspective to revised ICH guidelines, and challenges to implement the guideline in own region.

Learning Objectives

Recognize direction of revising ICH-GCP guideline; Discuss how to utilize it in real inspection.

Chair

Junko Sato, PhD

Speaker

FDA Update
Kassa Ayalew, MD, MPH

EMA Update
Peter Twomey

PMDA Update
Yoshiaki Nodera, MPharm


Speakers
avatar for Junko Sato

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
avatar for Kassa Ayalew

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with several years of clinical and... Read More →
avatar for Yoshiaki Nodera

Yoshiaki Nodera

Principal Inspector, Office of Non-clinical and Clinical Compliance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoshiaki Nodera currently serves as a principal inspector of the Office of Non-clinical and Clinical Compliance I in the Pharmaceuticals and Medical Devices Agency (PMDA). He joined PMDA in 2008 and had been working as a reviewer of biotechnological/biological products, medical devices... Read More →
avatar for Peter Twomey

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands
Peter is the Irish representative at both the GCP and PV EMA co-ordinated inspector working groups, a member of the GCP IWG CMDh working party (which focuses on bioequivalence inspections), and is a member of two expert groups tasked with proposing text for implementing acts of the... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session