eCTDXPress 301 / ISIPublisher 301: Business Process Workshop

Course Description
This three-day workshop takes attendees through understanding how eCTDXPress and ISIPublisher can be implemented within their business process. In this workshop, attendees will analyze their current business process, learn best practices for eCTDXPress, ISIPublisher, hyperlinking scenarios, and submission management. The ISI consultant will assess the client technical architecture to address any environmental constraints, and help attendees finalize an updated business process incorporating eCTDXPress and ISIPublisher.

The Business Process Workshop includes eCTDXPress 100.

Who Should Attend
This workshop is designed for users, managers, administrators and IT support personnel who are responsible for the client’s regulatory submissions business process.

Prerequisites

• Successful completion of eCTDXPress 204: eCTDXPress Full System Training and ISIPublisher 101: ISIPublisher Basic Training are strongly recommended
• Knowledge of existing business processes
• Basic knowledge of regulatory submissions process

Course Length
Three days.

Topics Covered

• eCTDXPress 100: An Overview of eCTDXPress
• Current Business Process Analysis and Discussion
• Best Practices: eCTD Process Overview
• Best Practices: Effective Hyperlinking
• eCTD Lessons Learned
• Best Practices: Submission Management
• Technical Check: System Architecture and Administration
• Business Process Finalization