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ICH 30th Anniversary Series: The Role of Multidisciplinary Topics
Session Chair(s)
Amanda Roache, MS
Deputy Vice President, 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)
ICH Data Standards and MedDRA
Director, Office of Strategic Programs, CDER, FDA, United States
ICH M11 Clinical electronic Structured Harmonized Protocol
Principal Consultant, Decision Analytics, United States
ICH Electronic Standards for the Transfer of Regulatory Information
Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
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