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#250: Pediatric Cluster Town Hall
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
209ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-588-L04-P; CME 1.00; RN 1.00

Representatives from pediatric cluster health authorities will describe the common deficiencies they see in global pediatric development programs and describe best practices and what to expect for those companies that seek a common commentary.

Learning Objectives

Describe common deficiencies in global pediatric development plans; Explain the process for obtaining a common commentary; Recognize topics that are discussed at monthly pediatric cluster calls.

Chair

Melodi J McNeil, MS, RPh

Speaker

PMDA Perspective
Junko Sato, PhD

EMA Perspective
Corinne de Vries, PhD, MA, MSc

Panelist
Franca Ligas

FDA Perspective
Dionna J. Green, MD

Australia Perspective
Robyn Langham, MD, PhD


Speakers
avatar for Dionna Green

Dionna Green

Director, Office of Pediatric Therapeutics, FDA, United States
Dr. Dionna J. Green is Director of the US Food and Drug Administration Office of Pediatric Therapeutics, a congressionally mandated office whose mission is to assure access for children to innovative, safe, and effective medical products. She leads an organization responsible for... Read More →
avatar for Robyn Langham

Robyn Langham

Chief Medical Adviser, Australia Health Products Regulation Group, Australia
Professor Langham is the Chief Medical Adviser of the Therapeutic Goods Administration, the therapeutic goods regulator in Australia. A nephrologist by training, Prof Langham has spent much of their career as a clinician researcher, in translational studies and drug development.
FL

Franca Ligas

Scientific Officer, Paediatric Medicines Office, European Medicines Agency, Netherlands
Franca Ligas serves as a Scientific Officer at the Paediatric Medicines Office of the European Medicines Agency (EMA), overseeing Paediatric Investigation Plans, particularly in oncology. Since 2021, she has led the Paediatric cluster from the EMA's side. Franca holds a medical degree... Read More →
avatar for Melodi McNeil

Melodi McNeil

Director, Regulatory Affairs (Global Regulatory Lead, Oncology Early Development, AbbVie, United States
Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
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 Corinne de Vries

Corinne de Vries

Head of Translational Sciences Office, European Medicines Agency, Netherlands
Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

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