ICH M11: Towards a Digital Future (LinkedIn Live Session Recording)

A big thank you to Kathie Clark for joining us in our LinkedIn Live session!

With her extensive experience in content management for the Life Sciences industry (eTMF, CTMS, Regulatory EDMS, submission publishing, RIM, QMS), Kathie shared her insights about the impact of ICH M11, and the transition to data-driven content and processes.

What did we cover during the session?

Some of the questions we explored during the session are:

• What is ICH M11?
• How does it relate to other industry initiatives?
• How are ICH, TransCelerate and CDISC working together to advance this initiative?
• Why does protocol digitization have the power to transform the clinical information flow?

And many more questions were covered during the discussion!

If you missed the session or want to revisit Kathie’s expert guidance, the recording is now available!

Visuals used during the session (courtesy of Kathie Clark Expert Services for Life Sciences

About the author

Kathie is President, Kathie Clark Expert Services for Life Sciences. Her background and experience includes  electronic Trial Master File (eTMF),  Clinical Trial Management Systems (CTMS),  Regulatory EDMS, submission publishing, Regulatory Information Management (RIM), Quality Management (QMS), and  Promotional Materials.

She has worked with hundreds of life sciences organizations around the world for over 25 years, including working with FDA eCTD reviewers while working for GlobalSubmit.  She served as a member of the TMF Reference Model steering committee for over 10 years.