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Session 7 Track 2: ICH M11 Clinical Electronic Structured Harmonized Protocol
Session Chair(s)
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
Speaker(s)
Speaker
Vivian Combs, MS
Eli Lilly and Company, United States
Director of Scientific Communications
Speaker
Vaishali Popat, MD, MPH
FDA, United States
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER
Speaker
Ken Sakushima, MD, PhD, MPH
Hokkaido University Hospital, Japan
Specially Appointed Associate Professor, Research and Development Division