FDA, EMA to Hold Crash Course on ICH M11 Guideline
Members of the International Council for Harmonization (ICH) committee behind the M11 guideline, which presents an electronic, standardized trial protocol template, will hold a public webinar to explain intended uses and benefits on Thursday, Jan. 26.
FDA’s Janice Maniwang, associate director for regulatory affairs for CDER’s Office of Medical Policy Initiatives, the European Medicines Agency’s Noémie Manent, principal scientific administrator, and Merck’s Mitzi Allred, director of clinical operations for clinical content standards, will walk attendees through the latest developments on the M11 guideline, its protocol template and the accompanying technical specification document.
The committee members will also go into detail on how the template was developed, the purpose of the technical specs in exchanging and storing trial data, and the benefits of using a standardized trial protocol. The FDA issued draft guidance signaling its endorsement of the M11 guideline last month (CenterWatch Weekly, Jan. 2).
The webinar runs from 10 am to 12 pm and will feature a Q&A session that stakeholders can submit questions for ahead of the event.
Register for the webinar here: https://bit.ly/3ixpmaL.
Submit questions by Jan. 20 here: https://bit.ly/3XqtSXv.