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Tuesday, June 16 • 9:30am - 10:30am
#210 SL: Clinical Electronic Structured Harmonized Protocol (CeSHarP): ICH M11 - Status Update

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-656-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Mary Lynn Mercado, PhD


ICH Overview
Noemi Manent

Reviewer Perspective
Vaishali Popat, MD, MPH

Breadth and Integration
Ken Sakushima, MD, PhD, MPH

Work Plan and Next Steps
Mary Lynn Mercado, PhD

avatar for Mary Lynn Mercado

Mary Lynn Mercado

Senior Group Head Regulatory Writing, Novartis Pharmaceuticals Corporation, United States
Mary Lynn Mercado is a US Group Head of Regulatory Medical Writing, Pharma at Novartis Pharmaceuticals Corporation. She has over 10 years of experience in the biopharmaceutical industry in Medical Writing, during which she has supported submissions across multiple therapeutic areas... Read More →
avatar for Noemi Manent

Noemi Manent

Scientific Administrator, Compliance and Inspection, European Medicines Agency
Noémie Manent joined the European Medicines Agency EMA in March 2011 as a Principal Scientific Administrator in the Compliance and Inspection Sector. She is involved in the coordination of EMA Good Clinical Practice (GCP) and pharmacovigilance inspections. She also has a major role... Read More →
avatar for Vaishali Popat

Vaishali Popat

Associate Directo, Biomedical Informatics & Regulatory Review Science, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →

Ken Sakushima

Medical Reviewer, Office of Advanced Evaluation with Electronic Data, Pharmaceuticals and Medical Devices Agency (PMDA)

Tuesday June 16, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Forum |   02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum