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ICH M11 Protocol Template: A Global Solution for Global Drug Development
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Advisor, Office of Regulatory Operations, CBER
FDA, United States
This session will highlight the latest developments of the ICH M11 Clinical Protocol Template including guidelines,protocol template, and technical specification and how these documents will facilitate more efficient and effective trials.
Learning Objective : Describe the M11 ICH deliverables and the latest developments on ICH M11 guideline, protocol template and technical specification; Describe the types trials and phase that the template encompasses; Discuss the technical specification as a technical representation of the template to facilitate electronic exchange.
Speaker(s)
Support of Digital Protocol Initiatives
Chris Decker, MS
CDISC, United States
President and Chief Executive Officer
The Value of Data: A Regulatory Perspective
Ana Zanoletty Perez
European Medicines Agency, Netherlands
Head of Clinical Trials Transformation Workstream
Global Synergy: Enhancing Patient Outcomes and Advancing Clinical Research Through International Protocol HarmonizationT
Vada A. Perkins, DrSc, MSc
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
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