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Practical Implementation of MRCTs Based on ICH E17 Guidelines
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Hear directly from the regulators and industry about the challenges and opportunities in applying the ICH E17 guidelines. Some cases based on ICH E17 guidelines will be presented in the panel. Panelists will be asked to make comments for each case regarding points to consider in planning a study or evaluating results.

Learning Objectives

Explain how ICH E17 guidelines are being implemented in the conduct of multiregional clinical trials; Evaluate the limitations, gaps, and opportunities for applying the guideline globally.

Chair

Yoshiaki Uyama, PhD, MS, RPh

Speaker

Panelist
Adriane Alves de Oliveira, MSc

Panelist
Hideki Hiraoka

Panelist
William Wang, PhD


Speakers
HH

Hideki Hiraoka

Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
avatar for Adriane Alves de Oliveira

Adriane Alves de Oliveira

Health Regulation Expert, Brazilian Health Regulatory Agency (ANVISA), Brazil
Health Regulation Expert with 11 years of experience monitoring non-clinical and clinical development of drugs and biological products, with a focus on monoclonal antibodies and vaccines. She is also Good Clinical Practice(GCP) inspector and participated as a representative of Anvisa... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →
avatar for William Wang

William Wang

President, Merck & Co, Inc, United States
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and a deputy topics-leader... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   02: ClinTrials-Ops, Session

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