Conference Description:

This seminar will provide an exploration of eCTDs and everything that happens before and after your organization produces a regulatory agency eCTD sequence. eCTD format submission delivery mandates exist for FDA submission types. Other agencies (EU, Health Canada…) are imposing eCTD format submission mandates as well. You will gain practical knowledge of the concepts, processes and tools which are utilized to produce submission ready documents, publish technically compliant eCTD sequences, transmit/deliver eCTD sequences, manage the publishing process, support eCTD lifecycle sequences, manage multiple eCTD product dossiers, and archive your eCTDs.

Learning Objectives:

>. Knowledge of the CTD/eCTD and its propose and construct

>. Describe the eCTD and the basic tools for eCTD implementation

>. Knowledge of the tools (software & process) utilized before, during, & after eCTD publishing

>. Understand what constitutes a Submission Ready Document

>. Understand the various tools associated with document/submission publishing and evaluate those tools against your company’s needs while assuring regulatory compliance.

Who Should Attend:

>. eCTD Publishers and Content Providers at Sponsors, CROs, Service Providers, Software Providers

>. Regulatory Operations Personnel

>. Regulatory Affairs Professionals

>. Anyone new to the eCTD Delivery Paradigm

>. Professionals preparing eCTD Marketing Applications for any Global Adopting Agency

>. Research and Development Professionals