ICH Public Webinar Will Provide an Update on the Latest Developments Concerning the M11 Harmonised Guideline and Protocol Template
The International Council for Harmonisation (ICH) M11 Expert Working Group (EWG) is organizing a public webinar to describe the latest developments on the ICH M11 Guideline. The EWG is holding this webinar on Thursday, Jan. 26, 2023 from 10:00 a.m. – 12:00 p.m. EST. Registration is open for this event, and registrants are invited to submit questions about this webinar in English using this form by Friday, Jan., 20, 2023. All information and presentations will be provided in English.
Click here to register for the webinar.
The webinar will include the following speakers from the ICH M11 committee:
- Janice Maniwang, U.S. Food and Drug Administration (FDA)
- Noémie Manent, European Medicines Agency (EMA)
- Mitzi Allred, Merck
During the webinar, these speakers will describe the latest developments on the M11 Guideline, Protocol Template, and Technical Specification; explain the benefits and opportunities created by the M11 Protocol Template; explain how the Protocol Template was developed; and explain the purpose of the technical specifications in supporting the exchange and storage of clinical trial data. There will also be a Q&A session at the end of the webinar during which the speakers will address a selection of questions submitted during registration.
For additional information on the ICH M11 Guideline, please see the ICH Guidelines site, M11 Draft Guideline, M11 Template, and M11 Technical Specification.