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ICH 30th Anniversary Series: The Role of Multidisciplinary Topics
Session Chair(s)
Amanda Marie Roache, MS
Senior Director, Science and Regulatory Advocacy
Pharmaceutical Research and Manufacturers of America (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
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
ICH M11 Clinical electronic Structured Harmonized Protocol
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
ICH Electronic Standards for the Transfer of Regulatory Information
Vada Perkins, DrSc, MSc
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
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