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Monday, June 15 • 1:30pm - 2:30pm
#122 L: ICH 30th Anniversary Series: Harmonizing Global Requirements for Clinical Trials

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-645-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of ICH efficacy topics instrumental to the harmonization of pharmaceutical development standards and an introduction to the new and revised topics that are currently underway. We will also discuss how ICH Guidelines apply now more than ever, in the time of a global pandemic. Additionally, an overview will be presented of ICH's GCP Renovation plan to provide updated guidance to address the increasing diversity of study types and data sources that support regulatory and other health policy decisions.

Learning Objectives

Discuss the role of ICH efficacy topics in harmonizing standards for more efficient pharmaceutical development and registration; Understand how ICH Guidelines help support drug development in the time of a global pandemic; Explain current ICH Guidelines being revised, new Guidelines being developed, and their anticipated impact to pharmaceutical development.

Chair

Amanda Marie Roache, MS

Speaker

Revision of ICH E6 Good Clinical Practices
M. Khair ElZarrad, PhD, MPH

Revision of ICH E8 General Consideration for Clinical Studies
Joanne Palmisano, MD, FACP

ICH E11A Pediatric Extrapolation
Lynne Yao, MD


Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →
avatar for M. Khair ElZarrad

M. Khair ElZarrad

Director, Office of Medical Policy, CDER, FDA, United States
Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →
avatar for Joanne Palmisano

Joanne Palmisano

Vice President, Head Global Regulatory Strategy, Vertex Pharmaceuticals, Inc.
Joanne Palmisano, MD, FACP, FRAPS Dr. Palmisano is a global regulatory leader with extensive biopharmaceutical drug development expertise in small molecule and biologics in multiple therapeutic areas. As Vice President Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc... 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 →

Monday June 15, 2020 1:30pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Session