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Wednesday, June 22 • 9:00am - 10:00am
#305: What’s New at ICH? From the E11A Pediatric Extrapolation Guideline to Model Informed Drug Development (MIDD)

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-599-L04-P ; CME 1.00; RN 1.00

The use of model-informed drug development (MIDD) has increasingly been incorporated into pediatric drug development programs. The ICH E11A guideline and the ICH MIDD discussion group will be used to open a discussion about different opportunities to use MIDD during drug development.

Learning Objectives

Describe current approaches to optimizing global drug development through quantitative methods such as model-informed drug development (MIDD) and pediatric extrapolation; Identify an update on the ICH E11A Pediatric Extrapolation guideline as well as an update from the ICH MIDD Discussion Group.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

FDA Update
Lynne Yao, MD

EMA Update
Andrew Thomson, PhD, MA, MS

Industry Update
Nicolas Frey, PharmD


Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchise. Over the past 20 years, moving from the French Medicines Agency/EMA... Read More →
avatar for Nicolas Frey

Nicolas Frey

Senior Leader, Clinical Pharmacometrics, Predictive Modeling and Data Analytics, F. Hoffmann-La-Roche Ltd., Switzerland
Nicolas Frey has more than 25 years of experience in the application of pharmacometric approaches to clinical drug development within the pharmaceutical industry and he was involved in more than 15 global filings across several therapeutic areas. He joined Roche in 2003. Nicolas is... Read More →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Wednesday June 22, 2022 9:00am - 10:00am CDT
Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  06: PreClinical Dev-EarlyPhaseCR, Forum |   11: Statistics, Forum