A recording for the International Council for Harmonisation’s public webinar, held January 26th, “New ICH M11 Harmonised Guideline, Protocol Template, and Technical Specification,” is now available.  

The webinar opened with welcoming remarks from Jacqueline Corrigan-Curay  of the U.S. Food & Drug Administration (U.S. FDA). Following the opening remarks, members of the M11 Expert Working Group—including Janice Maniwang of the U.S. FDA, Noémie Manent of the European Medicines Agency (EMA), and Mitzi Allred of Merck—provided detailed overviews of the M11 Guideline, Protocol Template, and Technical Specification. Following the presentations, the speakers also addressed questions that had been submitted during webinar registration. The webinar concluded with closing remarks from Ronald Fitzmartin of the U.S. FDA.    

View the full slide deck to learn more about the M11 Guideline, Protocol Template, and Technical Specification. The U.S FDA public consultation period opened on Thurs., Dec. 22, 2022 and will close on Tues., Feb. 21, 2023. Comments may be submitted on Regulations.gov. 

For additional information on the ICH M11 Guideline, please see the ICH Guidelines site, M11 Draft Guideline, M11 Template, and M11 Technical Specification.