Loading…
← Back to schedule
Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

The session explores the transformative impact of the ICH M11 digital protocol template on key clinical trial stakeholders, such as medical writers, standards professionals, and regulatory reviewers. It highlights how standardized, structured content

Learning Objectives

Understand the ICH M11’s Role in Digital Protocols Across Stakeholder Roles; Explore Customization and Multi-View Capabilities; Evaluate the Impact on Decision-Making and Efficiency for Key Roles; Examine Multi-Format Exchange of Protocol Information.

Speakers
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Advisor, Office of Regulatory Operations, CBER, FDA, United States
Ron Fitzmartin is a Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provides policy and strategy consultation on electronic regulatory submissions and standardized data. Ron serves as Rapporteur for... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Tweet Share
Share Modal

Share this link via

Or copy link