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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: The Role of Multidisciplinary Topics

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 key ICH Multidisciplinary topics and current efforts to promote more efficient drug development and registration.

Learning Objective : Discuss the role of the ICH multidisciplinary topics in harmonizing standards for more efficient pharmaceutical registration; Describe the role of standards development organizations (SDOs) and how they impact the development of ICH standards; Explain a new ICH harmonization effort to standardize organization and content of clinical protocols and development of a technical specification.

Speaker(s)

Mary Ann  Slack

ICH Data Standards and MedDRA

Mary Ann Slack

FDA, United States

Director, Office of Strategic Programs, CDER

Ron  Fitzmartin, PhD, MBA

ICH M11 Clinical electronic Structured Harmonized Protocol

Ron Fitzmartin, PhD, MBA

FDA, United States

Senior Advisor, Office of Regulatory Operations, CBER

Vada A. Perkins, DrSc, MSc

ICH Electronic Standards for the Transfer of Regulatory Information

Vada A. Perkins, DrSc, MSc

Boehringer Ingelheim, United States

Vice President, Global Head of Regulatory Intelligence & Policy

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