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#447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration
Monday June 15, 2026 4:00pm - 5:00pm EDT
108B
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-542-L04-P; CME 1.00; RN 1.00

This session reviews how ICH harmonization and new oncology MRCT guidelines from FDA, NMPA, and PMDA enable regulatory collaboration, speeding global trial start-up, drug development and patient access through shared data and adaptive approaches.

Learning Objectives

Analyze how regulatory harmonization and collaboration accelerate global study start-up; Differentiate key principles of ICH E17, E5, and regional oncology MRCT guidelines; Summarize strategies to navigate regional regulatory differences and enable global studies.

Chair

Angelika Joos, MPHARM

Speaker

ethical aspects of conducting MRCTs from a global perspective
Sarah A. White, MPH

Experience from global conduct of MRCTs
Aloka Chakravarty, PHD

Panelist
Paz Vellanki

PMDA perspective
Yoko Aoi, PHD


Speakers
avatar for Yoko Aoi

Yoko Aoi

Coordination Director - Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yoko Aoi is a Coordination Director, Office of Review Management at the PMDA of Japan. After joining PMDA, Dr. Aoi has been involved in regulatory review/scientific advice for new drugs, including treatments for rheumatoid arthritis, asthma, and COPD (2011–2016); coordination... Read More →
AC

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States
AC

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States
Dr. Aloka Chakravarty is VP, Statistical Data Insights and Advanced Analytics at Eli Lilly. Prior to that, she was the Director, Office of Biostatistics(A) at FDA where her career spanned 31 years. She is recipient of FDA Award of Merit, the highest scientific award conferred by the... Read More →
avatar for Angelika Joos

Angelika Joos

Executive Director, Science & Regulatory Policy, MSD, Belgium
Angelika Joos is a trained pharmacist. She is responsible for Clinical Research Policy issues within MSD's Science & Regulatory Policy department. This role includes identifying policy priorities that align with MSD’s business priorities, leading cross-functional networks to define... Read More →
PV

Paz Vellanki

Associate Director, OND, CDER, FDA, United States
avatar for Sarah White

Sarah White

Executive Director, MRCT Center, United States
Ms. White is the Executive Director at The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. In this capacity, she is responsible for developing and implementing the overall strategy and vision for the Center as well as oversee all management functions... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum |   08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Area Global Alignment in Practice
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Global Alignment in Practice
  • Interest Area Clinical Development & Operations,Regulatory
  • Tags Forum

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