Image Solutions, Inc.

Advanced eCTD Concepts and Business Process
Date	Location
February 22	Whippany, NJ
April 2	Whippany, NJ
May 20	San Francisco, CA
July 15	Whippany, NJ
August 19	Whippany, NJ
September 23	San Diego, CA
October 21	Whippany, NJ
October 24	London, England
December 2	Whippany, NJ

Workshop Length Instructor-led 1-day workshop	Note: To register for our workshops in EU, please click here.
Cost $995 / person; (Register for both the Introduction to eCTD and Advanced eCTD Concepts and Business Process Workshop and pay just $1749 / person for the two courses) Overview This workshop builds on the Introduction to eCTD workshop to introduce participants to advanced eCTD concepts and business processes. Through interactive discussions and hands-on demonstrations, participants will gain from the experiences that ISI has encountered while preparing submissions, implementing eCTD software and defining business processes. Lessons from actual cases are distilled; participants will have a chance to ask questions and learn from best practice suggestions. In addition, this one-day workshop features discussions on methods to prepare documents, hyperlinking strategies, testing your eCTD technology with a Pilot submission and methods to send your submission. Advanced eCTD Concepts and Business Process is lead by expert consultants and trainers who have masterful knowledge of eCTD and regulatory submissions. Our trainers have presented at industry conferences, authored publications and written courses and textbooks on eCTD and other industry topics. With over 400 successful eCTD submissions, ISI is committed to passing on field-tested experience and best practices to workshop participants. Workshop Details Who Should Attend This workshop is designed for industry professionals familiar with eCTD, but desire to enhance their knowledge of advanced eCTD concepts and business processes. This includes professionals in: Medical Writing, Regulatory Affairs, Dossier and Document Management, IT and Data Management, Compliance, Publishing and Submission Management. Prerequisite Introduction to eCTD is recommended if you have little to no experience with eCTD before taking this workshop. Workshop Materials Along with the knowledge that will be acquired from this workshop, an Advanced eCTD Concepts and Business Process Workbook is provided. Following the same structure as the workshop, the Workbook is filled with industry-sensitive information and also provides references to many of the guidance documents developed by the FDA and the web addresses to access them. Workshop Learning Objectives After attending this workshop participants will have had the opportunity to: Define best practices for a planning a submission Understand the benefits of using document templates Introduce the concept of document management Become familiar with when and where hyperlinking content is appropriate Discuss unique documents such as SPL, PIM, CDISC and legacy documents Identify the types of physical media that can be submitted Understand why the FDA requires a pilot eCTD submission Discuss the requirements of a pilot eCTD submission Talk over the FDA’s ESG and receipt date View the agency review tools, Global Submit (FDA) and EURS (EMEA) Review the paper publishing process Identify the requirements for paper submissions Learn how to perform QC on paper publishing Explore the stages of developing an eCTD strategy and approach Identify the process changes that need to occur and set goals Make recommendations to help start the process of change Become aware of the critical top issues seen by the FDA when reviewing an eCTD. Lesson Topics Submission Strategies This lesson begins the benefits of using templates to author each granular document, then continues with an overview of the methods available to manage documents. The what, when, why and how’s of hyperlinking are then discussed in detail with specific examples. Special Document Types SPL, PIM, CDISC and legacy documents are ex¬plained, as well as how to handle these documents in an eCTD Submission Quality Control This lesson illustrates the need for a complete quality control process and details QC Process Elements, such as document content, submission metadata and validating XML against DTD. This lesson will also go through common issues identified by the FDA and best practice on how to avoid common pitfalls. Paper Submissions This lesson reviews the process for paper publishing a submission. It also presents differences between the paper and electronic submission and issues that concern only a paper submission, such as paper size, additional TOCs and cross-references. Electronic Submission Logistics This lesson introduces the new electronic gateway used by the FDA to receive submissions electronically. It begins with the process to pilot a submission with the FDA and what the FDA is looking for in a pilot, and then takes you through an actual submission.