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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 2: ICH M11 Clinical Electronic Structured Harmonized Protocol

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior Advisor, Office of Regulatory Operations, CBER

FDA, United States

This Special Session will be an interactive session that will solicit early feedback from the attendees on development of the ICH guideline and template for a harmonized clinical protocol. The speakers will be M11 Expert Working Group speakers including the Rapporteur and Regulatory Chair. They will engage all relevant stakeholders and get early input on important design and content considerations which have been developed by the EWG. Presentations will include the business plan and perceived benefit of this effort expressed by SMEs from regulators and sponsors, high-level design principles, 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 :

At the conclusion of this session, participants should be able to:

  • Identify the key objectives of the ICH M11 Expert Working Group
  • Describe the benefits of a harmonized clinical protocol template
  • Recognize the interdependencies with other ongoing ICH efforts


Vivian  Combs, MS


Vivian Combs, MS

Eli Lilly and Company, United States

Director of Scientific Communications

Vaishali  Popat, MD, MPH


Vaishali Popat, MD, MPH

FDA, United States

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

Ken  Sakushima, MD, PhD, MPH


Ken Sakushima, MD, PhD, MPH

Hokkaido University Hospital, Japan

Specially Appointed Associate Professor, Research and Development Division

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