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#558: Advancing Pediatric Drug Development in Asia through Real-World Evidence and Regulatory Innovation
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
115C
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-593-L04-P; CME 1.00; RN 1.00

This session will showcase how Real-World Evidence (RWE) supports pediatric drug development in Asian countries, share US and EU perspectives, and highlight innovations in regulatory strategies, policies, and methodologies to enhance regulatory-grade pediatric RWE.

Learning Objectives

Demonstrate emerging trends in the use of RWE in regulatory decision-making in Asia, with real examples of leveraging RWE to accelerate pediatric drug development, highlighting innovative approaches and successful outcomes; Discuss challenges and strategies for high-quality pediatric RWE and explore regulatory frameworks for RWE evaluation through innovative cross-organizational collaborations.

Chair

Yongjing Zhang, PHD

Speaker

Panelist
Reiko Nakashima

Panelist
Shaoqing Ni, PHD

Panelist
Ju-Young Shin, PHD


Speakers
avatar for Reiko Nakashima

Reiko Nakashima

Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Ms. Reiko Nakashima is a Deputy Review Director in the Office of New Drug III at the Pharmaceuticals and Medical Devices Agency (PMDA), where she is responsible for the review of new drugs for central nervous system (CNS) disorders.
SN

Shaoqing Ni

Attending Pharmacist , Director, Children's Hospital Zhejiang University School of Medicine, China
30+ years in pediatric pharmacy & clinical research. PhD, Chief Pharmacist, Doctoral Supervisor. Director of Clinical Trial Office, Children's Hospital, Zhejiang University; Head of Secretariat, China Pediatric Clinical Trial Network; Course Director, Zhejiang University graduate... Read More →
avatar for Ju-Young Shin

Ju-Young Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health... Read More →
YZ

Yongjing Zhang

Senior Director, Global Epidemiology, Johnson & Johnson, China
Dr. Zhang has been working on Real-World research in the pharmaceutical and medical device industry for over 18 years. He is dedicated to promoting global universal standards for electronic health databases in the Asia-Pacific region, practicing emerging theories and methods in epidemiological... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   10: Stats-EvidenceGeneration-RWE, Session
  • Audience Intermediate
  • Area Evidence Innovation
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Data Management & Data Standards
  • Feature Topics Evidence Innovation
  • Tags Session

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