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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

Clinical Electronic Structured Harmonized Protocol (CeSHarP): ICH M11 - Status Update

Session Chair(s)

Mary Lynn  Mercado, PhD

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

ICH Overview

Noemie Manent, PharmD

European Medicines Agency, Netherlands

TDA-CTT Operations Workstream Lead

Vaishali  Popat, MD, MPH

Reviewer Perspective

Vaishali Popat, MD, MPH

FDA, United States

Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER

Ken  Sakushima, MD, PhD, MPH

Breadth and Integration

Ken Sakushima, MD, PhD, MPH

Hokkaido University Hospital, Japan

Specially Appointed Associate Professor, Research and Development Division

Mary Lynn  Mercado, PhD

Work Plan and Next Steps

Mary Lynn Mercado, PhD

Novartis Pharmaceuticals Corporation, United States

Senior Group Head Regulatory Writing

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