Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ICH 30th Anniversary Series: Harmonizing Global Requirements for Clinical Trials

Session Chair(s)

Amanda Marie Roache, MS

Amanda Marie Roache, MS

Senior Director, Science and Regulatory Advocacy

Phrma, United States

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 Objective : 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.

Speaker(s)

M. Khair  ElZarrad, PhD, MPH

Revision of ICH E6 Good Clinical Practices

M. Khair ElZarrad, PhD, MPH

FDA, United States

Director, Office of Medical Policy, CDER

Joanne  Palmisano, MD, FACP

Revision of ICH E8 General Consideration for Clinical Studies

Joanne Palmisano, MD, FACP

Vertex Pharmaceuticals, United States

Vice President, Head Global Regulatory Strategy

Lynne  Yao, MD

ICH E11A Pediatric Extrapolation

Lynne Yao, MD

FDA, United States

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.