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Clinical Electronic Structured Harmonized Protocol (CeSHarP): ICH M11 - Status Update
Session Chair(s)
Mary Lynn Mercado, PhD
Senior Group Head Regulatory Writing, Novartis Pharmaceuticals Corporation, United States
Creation of a new guideline to specify a comprehensive clinical protocol organization and flexible content components was mandated by the ICH assembly in June 2018 and the established Expert working group {ICH M11 EWG} has made substantial progress. The purpose of this is to engage all relevant stakeholders and get early input on important design and content considerations which have been developed by the EWG.
This session will include the business plan and perceived benefit of this effort expressed by SMEs from regulators and the sponsors, high-level design principles followed, as well as the overall deliverables, status and roadmap to delivery in order to get early input for consideration. Interdependencies with other ongoing ICH efforts and alignment steps will also be presented.
Learning Objective : Discuss the status of the harmonization efforts of the clinical trial protocol template under the umbrella of ICH; Outline early feedback from various stakeholders for early consideration.
Speaker(s)
Noemie Manent, PharmD
TDA-CTT Change Management Lead, European Medicines Agency, Netherlands
ICH Overview
Vaishali Popat, MD, MPH
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States
Reviewer Perspective
Ken Sakushima, MD, PhD, MPH
Specially Appointed Associate Professor, Research and Development Division, Hokkaido University Hospital, Japan
Breadth and Integration
Mary Lynn Mercado, PhD
Senior Group Head Regulatory Writing, Novartis Pharmaceuticals Corporation, United States
Work Plan and Next Steps
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