FDA News Audioconference

Join Nancy Smerkanich, vice president of Regulatory Affairs, John Lawrie, vice president of Process Solutions and Pam Pagnotta, principal consultant, Process Solutions at Octagon Research Solutions, Inc., during an FDANews audiconference presentation entitled: eCTDs: Dos and Don'ts for CDER's Electronic Requirement.

Listeners of this audioconference will receive a thorough explanation of the need for submission lifecycle management, which requires both technology and process understanding of the challenges of tracking and managing submissions over the lifetime of the application. Additionally, Octagon’s instructors will address the questions that have been created by the specifications and guidances. Understanding these, and how they have been answered in the field, can help provide a controlled, manageable transition to eCTD.