Liquent Education Services Course Catalog 2013

Liquent Education Services Course Catalog Course Number:............................................................................. CC Course Edition: .............................................................................. 2012 For software version: ..................................................................... Var Published:....................................................................................... 06/12 This document, as well as the software described in it, is provided under a software license agreement with Liquent. Use of this software and all related documentation is subject to and limited by the terms and conditions stated in such software license agreement. The content of this document is furnished for informational use only, is subject to change without notice, and should not be construed as a commitment by Liquent. Liquent assumes no responsibility or liability for any errors or inaccuracies that may appear in this document. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose without the express permission of Liquent. Copyright © 2012. Liquent Inc.. All rights reserved. Copyright protection claimed includes all forms and matters of copyrightable material and information now or hereafter allowed by statutory or judicial law, including without limitation, material generated from the software programs, which are displayed on the screen, such as icons, screen displays, graphics, user interfaces, and so on. Government and Civilian Agency Restricted Rights Legend. Use, duplication, or disclosure is subject to restrictions as set forth in subparagraph (c)(1)(ii) of the Rights in Technical Data and Computer Software clause at DFARS 25.227-7013 and subparagraphs (a) through (d) of the Commercial Computer Software Restricted Rights clause at 48 CFR 52.227-19, and clause 18-52.277-86(d) of the NASA supplement to the FAR, as applicable, and the limitations set forth in the Liquent software license agreement. The contractor/ manufacturer is Liquent, 101 Gibraltar Rd., Second Floor, Horsham, PA 19044. Liquent CoreDossier, Liquent EZsubs, Liquent InSight, Liquent PDFaqua, Liquent RenderPerfect, Liquent UltraLink are registered trademarks of Liquent, Inc. Liquent InSight Foundation, Liquent InSight Manager, Liquent InSight Publisher, Liquent InSight Viewer, Liquent eCTD Reviewer, Liquent SmartLink, Liquent SmartLink for Word, Liquent Authoring Manager, InSight Xref, and Xref Manager are trademarks of Liquent, Inc. a-Pulse, eCTDViewer Web Edition, eCTDGateKeeper, S-Cubed: CRT, S-Cubed: eCTD, S-Cubed: NeeS, S-Cubed: Publisher, SCubed: Templates, Tracking XML, Vue, eCTDBuilder, eCTDViewer are registered trademarks of Liquent, Inc. All other trademarks and registered trademarks are the properties of their respective companies or mark holders.

Printed in the United States of America.

TABLE OF CONTENTS Welcome to Liquent Education Services ............................................................................. 1 Training Options ............................................................................................................. 2 Instructor-led Classes ................................................................................................... 2 Private Group Training.................................................................................................. 2 On-site Classes ........................................................................................................... 2 Customized Training .................................................................................................... 2 Liquent Learning Network.............................................................................................. 2 Custom Development ................................................................................................... 3 Registering for Liquent Courses ........................................................................................ 4 Registration ................................................................................................................ 4 Rescheduling/Cancellation ............................................................................................ 4 Payment ..................................................................................................................... 4 Class Locations ........................................................................................................... 4 Certificates of Completion ............................................................................................. 4 Course Schedules........................................................................................................ 4 Liquent InSight® FOR Registration .................................................................................... 7 Course Description....................................................................................................... 7 Topics Include............................................................................................................. 7 Audience .................................................................................................................... 7 Prerequisites ............................................................................................................... 7 Liquent InSight® for Registration for Medical Device Users.................................................... 8 Course Description....................................................................................................... 8 Topics Include............................................................................................................. 8 Audience .................................................................................................................... 8 Prerequisites ............................................................................................................... 8 Liquent InSight® Product Detail Management ..................................................................... 9 Course Description....................................................................................................... 9 Topics Include............................................................................................................. 9 Audience .................................................................................................................... 9 Prerequisites ............................................................................................................... 9 Liquent InSight® Advanced Planning & Tracking............................................................... 10 Course Description..................................................................................................... 10 Topics Include........................................................................................................... 10 Audience .................................................................................................................. 10

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Prerequisites ............................................................................................................. 10 Administering the Liquent InSight® Suite .......................................................................... 11 Course Description..................................................................................................... 11 Topics Include........................................................................................................... 11 Audience .................................................................................................................. 11 Prerequisites ............................................................................................................. 11 Liquent InSight® for Commitments & Correspondence....................................................... 12 Course Description..................................................................................................... 12 Topics Include........................................................................................................... 12 Audience .................................................................................................................. 12 Prerequisites ............................................................................................................. 12 Liquent InSight® for European Union Applications............................................................. 13 Course Description..................................................................................................... 13 Topics Include........................................................................................................... 13 Audience .................................................................................................................. 13 Prerequisites ............................................................................................................. 13 Executive Overview for

Liquent InSight® for Registrations ............................... 14

Course Description..................................................................................................... 14 Topics Include........................................................................................................... 14 Audience .................................................................................................................. 14 Prerequisites ............................................................................................................. 14 Publishing with Liquent InSight® for eCTD and Paper......................................................... 16 Course Description..................................................................................................... 16 Topics Include........................................................................................................... 16 Audience .................................................................................................................. 16 Prerequisites ............................................................................................................. 16 Publishing with Liquent InSight® for eCTD and NeeS ......................................................... 17 Course Description..................................................................................................... 17 Topics Include........................................................................................................... 17 Audience .................................................................................................................. 17 Prerequisites ............................................................................................................. 17 Publishing with Liquent InSight® for Paper........................................................................ 18 Course Description..................................................................................................... 18 Topics Include........................................................................................................... 18 Audience .................................................................................................................. 18 Prerequisites ............................................................................................................. 18 Report Level Publishing with Liquent InSight® ................................................................... 19

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Course Description..................................................................................................... 19 Topics Include........................................................................................................... 19 Audience .................................................................................................................. 19 Prerequisites ............................................................................................................. 19 Advanced Publishing with Liquent InSight®....................................................................... 20 Course Description..................................................................................................... 20 Topics Include........................................................................................................... 20 Audience .................................................................................................................. 20 Prerequisites ............................................................................................................. 20 *Prices will be charged in the local currency of the training venue, and may be subject to taxes. 20 Liquent InSight® Administration for Publishers................................................................... 21 Course Description..................................................................................................... 21 Topics Include........................................................................................................... 21 Audience .................................................................................................................. 21 Prerequisites ............................................................................................................. 21 What’s New with Publishing with Liquent InSight®.............................................................. 22 Course Description..................................................................................................... 22 Topics Include........................................................................................................... 22 Benefits .................................................................................................................... 22 Audience .................................................................................................................. 22 Prerequisites ............................................................................................................. 22 Reviewing Submissions with Liquent InSight® for Viewing.................................................. 23 Course Description..................................................................................................... 23 Topics Include........................................................................................................... 23 Audience .................................................................................................................. 23 Prerequisites ............................................................................................................. 23 Publishing with Liquent InSight® Certified Professional Exam Preparation Course .................. 24 Course Description..................................................................................................... 24 Topics Include........................................................................................................... 24 Audience .................................................................................................................. 24 Prerequisites ............................................................................................................. 24 *Prices will be charged in the local currency of the training venue, and may be subject to taxes. 24 Publishing with Liquent InSight® Certified Professional Exam .............................................. 25 Course Description..................................................................................................... 25 Topics Include........................................................................................................... 25 Audience .................................................................................................................. 25 Prerequisites ............................................................................................................. 25

III

*Prices will be charged in the local currency of the training venue, and may be subject to taxes. 25 Publishing with Liquent S-Cubed eCTD and Non-eCTD® .................................................... 27 Course Description..................................................................................................... 27 Topics Include........................................................................................................... 27 Audience .................................................................................................................. 27 Prerequisites ............................................................................................................. 27 Publishing with Liquent S-Cubed®: Publisher for Paper ...................................................... 28 Course Description..................................................................................................... 28 Topics Include........................................................................................................... 28 Audience .................................................................................................................. 28 Prerequisites ............................................................................................................. 28 Publishing with Liquent S-Cubed: Non-CTD & Report Level Publishing (RLP)® ...................... 29 Course Description..................................................................................................... 29 Topics Include........................................................................................................... 29 Audience .................................................................................................................. 29 Prerequisites ............................................................................................................. 29 Publishing with Liquent S-Cubed: CTD, Non-CTD & Report Level Publishing (RLP)® .............. 30 Course Description..................................................................................................... 30 Topics Include........................................................................................................... 30 Audience .................................................................................................................. 30 Prerequisites ............................................................................................................. 30 Liquent S-Cubed®: Publisher Administrator Console ......................................................... 31 Course Description..................................................................................................... 31 Topics Include........................................................................................................... 31 Audience .................................................................................................................. 31 Prerequisites ............................................................................................................. 31 Document Authoring with Liquent S-Cubed®: Templates.................................................... 32 Course Description..................................................................................................... 32 Topics Include........................................................................................................... 32 Audience .................................................................................................................. 32 Prerequisites ............................................................................................................. 32 Liquent S-Cubed®: Administrator Console ...................................................................... 33 Course Description..................................................................................................... 33 Topics Include........................................................................................................... 33 Audience .................................................................................................................. 33 Prerequisites ............................................................................................................. 33 What’s new in Liquent S-Cubed® version 5.0 .................................................................... 34

IV

Course Description..................................................................................................... 34 Topics Include........................................................................................................... 34 Audience .................................................................................................................. 34 Prerequisites ............................................................................................................. 34 Automating the Publishing process with Liquent Smartdesk for pdf® ..................................... 36 Course Description..................................................................................................... 36 Topics Include........................................................................................................... 36 Audience .................................................................................................................. 36 Prerequisites ............................................................................................................. 36 Reviewing Submissions with Liquent e CTD Viewer Web Edition® ....................................... 37 Course Description..................................................................................................... 37 Topics Include........................................................................................................... 37 Audience .................................................................................................................. 37 Prerequisites ............................................................................................................. 37 Validating Submissions with Liquent e CTD GateKeeper®................................................... 38 Course Description..................................................................................................... 38 Topics Include........................................................................................................... 38 Audience .................................................................................................................. 38 Prerequisites ............................................................................................................. 38 Overview .................................................................................................................. 40 Course Offerings........................................................................................................ 40 Custom Development ................................................................................................. 40 Education and Registration Information ............................................................................ 41

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WELCOME TO LIQUENT EDUCATION SERVICES Liquent is committed to a learning environment that stimulates the participant’s interest and encourages questions. Education Services offers “results-oriented” training, which combines qualified instructors, state-of-the-art courseware and high-tech facilities. Classroom and onsite courses provide a computer for each participant and reinforce concepts and skills through exercises and hands-on experience. Our Liquent Learning Network provides a just in time training solution, that brings a blend of instructor-led and self-paced learning modules to students anytime, anywhere. Our goal is for the participant to leave our seminars confident and experienced in the skills presented. We meet this goal by offering: • Our professional instructor’s skill and experience. • Hands-on examples of business applications. • Opportunities for independent exercises designed to reinforce your new skills. • Plenty of time for questions and answers. Some courses have prerequisites, which are enforced to ensure all students can develop basic performance skills. Course overviews can be found in this Education Catalog, and will help in evaluating course content before registration.

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TRAINING OPTIONS These educational opportunities are available for learning Liquent’s software offerings. This catalog lists all courses available. For additional information regarding training, please call us directly at 215.347.1803 (U.S.) or send email to [email protected].

Instructor-led Classes Traditional classroom settings allow students to interact with our highly trained professional staff creating a positive learning environment. Liquent’s schedule of courses, published quarterly, is accessible via our web site at www.liquent.com . Students may enroll in any available course at one of our two Education Centers: Horsham (PA), or Uxbridge (UK).

Private Group Training Group training allows companies to schedule an entire classroom for exclusive use in any of our education centers.

On-site Classes Liquent’s mobile classroom suits the need of some clients. Qualified instructors come to your site for staff training, on one topic or for numerous classes. Register online, or call for details, availability and costs.

Customized Training International Education Services can create customized training that matches your business process and environment. Staff can learn specific features and functions and how the company plans to use our software in each environment. Highly qualified Liquent Instructional Designers are available to produce training courses using your documents, your data, your templates and your business processes.

Liquent Learning Network The Liquent Learning Network is an easy-to-use client interface that gives you access to personalized, self-service learning programs and a learner searchable catalog of learning resources. These learning resources provide a host of courses with multiple delivery styles including self-paced, online, live courses, assessments, surveys, and recorded events. The Liquent Learning Network leverages Geo Learning as the platform for Liquent’s Learning Management System. Geo Learning enables easy access to recorded webcasts and self-paced online courses. The Liquent Learning Network currently offers packages of courses, and individual courses. Course packages are designed by series and include an instructional plan that navigates student development. Individual courses are also available for learners who wish to personalize their learning experience to a specific component or unit of instruction. All courses and packages are accessible to the student within a certain time period; depending on the course selection the time period can range from 30 days to 120 days. To inquire about current course offerings for all online courses delivered through the Liquent Learning Network, please contact your Account Executive.

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Benefits of the Liquent Learning Network include: • Users can learn at their own computer, without leaving the work site. • Training may be completed in bite-size chunks, when and where it is needed. • eLearning satisfies the training needs of a geographically dispersed workforce, without large investments in Travel and Living expenses. • Training can be completed at the learner’s own pace. • Interactive training activities allow users to develop and practice skills easily. • Learners receive a consistent message regardless of when or where they access training.

Custom Development Liquent can customize your eLearning experience by designing courses for your business. Custom course development is available for all delivery styles including self-paced online modules, blended live and online courses, and recorded webcasts with supplemental student materials. Custom courses can be deployed in your environment through the following accessibility points: HTML, CD, AICC, SCORM 1.2 or single file executable. Custom courses can also be delivered privately on the Liquent Learning Network solely for your learner base. To inquire about custom development opportunities, please contact [email protected].

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REGISTERING FOR LIQUENT COURSES Registration Please register online at www.liquent.com. For questions about course availability, please call Education Services in the US 215.347.1803, or send email to [email protected]. Class size is restricted, so call early to avoid disappointments. Pre-registration is required to attend classes. You will receive confirmation of your registration via email.

Rescheduling/Cancellation Course fees are refundable with at least 10 business days’ notice prior to start of class. Other cancellations are subject to a 50% cancellation fee. Substitutions may be made up to the start of class. Liquent reserves the right to cancel any training course due to insufficient enrollment or other events beyond our control by providing notice at least 5 business days prior to scheduled start date. The client understands and agrees that Liquent shall not, in any way, be held responsible for any costs, including loss of airfare or other transportation, hotel costs, or any other expenses incurred. In case of inclement weather, please call our office to determine if class is being held: Horsham, PA, USA: 215-347-1803 Uxbridge, UK: + 44 (1) 895 2380000. Course dates, pricing and course locations are subject to change.

Payment Liquent provides three alternatives for payment. The first option is to have Liquent invoice students after attending class. A purchase order is required for an invoiced registration. Please include all relevant purchase order information, as well as an accounts payable contact name, on the registration form. Classes may also be paid for by check or by using a credit card. If you prefer to use your credit card, we will hold your registration until we receive confirmation from your credit card company. We accept Visa, MasterCard and American Express. Course fees will be charged in the currency of the training venue. Registrations in the U.S. may be subject to state sales tax. European registrations may be subject to 17.5% V.A.T.

Class Locations Liquent has two Education Centers to serve your needs. In the United States, our Education Center is located in Horsham, Pennsylvania (the northern suburbs of Philadelphia). In Europe, our Education Center is located in Uxbridge, United Kingdom. Information on local accommodations can be found on our website.

Certificates of Completion Upon fulfillment of class requirements you will receive a Certificate of Completion. Unless otherwise indicated, classes are held from 9:00am until 4:00pm. Liquent will be unable to issue an official Certificate of Completion if you choose to leave before the end of the class. Certificates for the Liquent Certified Professional program will be mailed to students once their exams have been scored (usually within one week of the exam session).

Course Schedules Course schedules can be found on our web site, or can be obtained from Education Services. Contact International Education Services at 215.347.1803 (U.S.), or send a request via email. 4

Liquent InSight Course Matrix The following table identifies the courses that are available for each module of the Liquent InSight suite. Please use this as a guide when registering for Liquent InSight courses.

Course Name

ELP

PRP

RDA

Publishing with Liquent InSight for eCTD & Paper

*

*

*

Publishing with Liquent InSight for eCTD & NeeS

*

*

*

Paper Publishing with Liquent InSight

SPT

RPT

PDM

Module Acronym Key

*

Report Level Publishing with Liquent InSight

*

*

Advanced Publishing with Liquent InSight

*

*

*

Liquent InSight Administration for Publishers

*

*

*

Liquent InSight Submission Planning and Tracking

*

Liquent InSight Registration Planning and Tracking

*

Liquent InSight Registration Planning and Tracking and Product Detail Management

*

Liquent InSight Product Detail Management

* *

Advanced Liquent InSight Planning and Tracking

*

*

*

Administering the Liquent InSight Suite

*

*

*

5

ELP

Electronic Lifecycle Publishing or InSight Publisher

PRP

Paper Review Publishing

RDA

Registered Document Analysis

SPT

Submission Planning and Tracking

RPT

Registration Planning and Tracking

PDM Product Detail Management

Liquent InSight® for Planning & Tracking

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LIQUENT INSIGHT® FOR REGISTRATION Course Description This interactive one and a half day course will introduce students to the features of the Liquent InSight for Registration module. Users will learn to create the key entities and enter the data necessary to track the registration process for new and existing pharma, veterinary or medical device products.

Topics Include • • • •

• •

Understanding the InSight Data Structure Navigating InSight Working with Product Families Creating Products, Components and Active Ingredients

•

Working with Submission Wizards Creating Applications, Events and Sequences Querying InSight

Audience • •

Clients responsible for tracking data associated with a planned pharma or veterinary registrations in a country or countries. Clients responsible for compliance with agency guidelines for existing product registrations.

Prerequisites  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of Microsoft Internet Explorer 7.0 or higher. Duration/Pricing* One and a Half Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$975

Uxbridge, UK €1043

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

7

LIQUENT INSIGHT® FOR REGISTRATION FOR MEDICAL DEVICE USERS Course Description This interactive one and a half day course will introduce students to the features of the Liquent InSight for Registrations module as they pertain to medical device products. Users will learn to enter the data necessary to track the registration process for bundled submissions for new and existing medical device products.

Topics Include • • • •

•

Understanding the InSight Data Structure Navigating InSight Developing Product Family data Creating Products and Components

• •

Creating Applications and supporting data structures Using Projects to create and manage regulatory objectives and registrations Querying InSight

Audience • •

Clients responsible for tracking data associated with planned and existing medical device registrations in a country or countries. Clients responsible for compliance with agency guidelines for existing product registrations.

Prerequisites  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of Microsoft Internet Explorer 7.0 or higher. Duration/Pricing* One and a Half Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$975

Uxbridge, UK €1043

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

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LIQUENT INSIGHT® PRODUCT DETAIL MANAGEMENT Course Description This interactive one-day course is only offered in conjunction with the 1.5 day InSight for Registrations module training. It introduces students to the features of the InSight Product Detail Management module, which allows users to create and track the granular, product information associated with approved and pending registrations.

Topics Include • • • •

• •

Understanding the InSight Data Structure Navigating InSight Working with Product Families Creating Products, Components and Active Ingredients

•

Working with Submission Wizards Creating Applications, Events and Sequences Querying InSight

Audience •

Clients whose responsibilities include tracking CMC and product details for approved, and pending approval, pharmaceutical, veterinary and medical device products.

Prerequisites  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of Microsoft Internet Explorer 7.0 or higher. Duration/Pricing* One Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$650

Uxbridge, UK €695

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

9

LIQUENT INSIGHT® ADVANCED PLANNING & TRACKING Course Description This interactive one and a half day course will introduce students to advanced features in the InSight system: creating and managing global project plans (“GPP”) and event plans. These functionalities address the needs of users of InSight for Registrations, InSight for Submission and Product Detail Management modules who manage pharmaceutical, veterinary and medical device product data.

Topics Include • • • •

•

Creating and applying Event Plans Creating Applications using GPP and Copy Application Creating Events using GPP and Copy Event Using GPP to Manage Product Details

• •

Withdrawing approved product data through GPP Creating sequences and references in a project Using GPP to Manage Event Status

Audience • •

Clients responsible for regulatory data changes that affect multiple applications and product lines. Clients familiar with basic InSight functionality.

Prerequisites  User training in InSight for Registrations, InSight Product Detail Management or InSight for Submissions.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of Microsoft Internet Explorer 7.0 or higher. Duration/Pricing* One and a Half Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$975

Uxbridge, UK €1043

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

10

ADMINISTERING THE LIQUENT INSIGHT® SUITE Course Description This interactive one and a half day course will enable students to understand administrator roles and functions: managing user access permissions (Security Administration), connecting InSight to external repositories (Technical Administration) and managing data values (Data Administration). This course supports all license modules of InSight.

Topics Include • • •

• •

Security Administration Technical Administration InSight Architecture

Data Administration Administration Reporting

Audience •

Clients who will provide administrative support for any of the InSight modules.

Prerequisites  Attendance in the following course: User training for one or more of the InSight modules.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of Microsoft Internet Explorer 7.0 or higher. Duration/Pricing* One and a Half Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$975

Uxbridge, UK €1043

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

11

LIQUENT INSIGHT® FOR COMMITMENTS & CORRESPONDENCE Course Description This interactive half-day course introduces students to the Commitments and Correspondence capabilities of the InSight for Registrations and Submissions modules. It introduces students to InSight’s Reference, Task and Notification functionalities which allow users to track and assign commitments and other tasks that support regulatory objectives.

Topics Include • •

•

Creating links to external content using References Creating and copying assignments in InSight using Task functionality

•

Creating Task Progression Workflows Creating InSight E-mail alerts using local and global notifications

Audience •

Clients whose responsibilities include tracking agency commitments and correspondence, managers and employees who will assign/be assigned tasks in InSight, users who will create and maintain notifications in InSight.

Prerequisites  Prior training in InSight for Registrations or InSight for Submissions.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of Microsoft Internet Explorer 7.0 or higher. Duration/Pricing* Half Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$325

Uxbridge, UK €348

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

12

LIQUENT INSIGHT® FOR EUROPEAN UNION APPLICATIONS Course Description This interactive half-day course introduces students to the InSight’s management of European applications. It introduces students to multi-country applications, country and product tracking, package set (presentation) registrations and the Sunset Clause report.

Topics Include • • •

•

Creating a centralized procedure (“CP”) application Creating and maintaining a mutual recognition (“MRP”)/decentralized procedure (“DCP”) application

• •

Tracking country status using EventCountry functionality Package Set Registrations and Sunset Clause querying Creating a European clinical trial authorisation application (“CTA”)

Audience •

Clients whose responsibilities include planning and tracking multi-country European applications.

Prerequisites  Prior training in InSight for Registrations or InSight for Submissions.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of Microsoft Internet Explorer 7.0 or higher. Duration/Pricing* Half Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$325

Uxbridge, UK €348

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

13

EXECUTIVE OVERVIEW FOR LIQUENT INSIGHT® FOR REGISTRATIONS Course Description This interactive half-day course introduces executives and managers to the scope of InSight’s functionality and capability: creating product records, using Global Project Planning (“GPP”) to create and maintain multiple applications and regulatory objectives simultaneously, managing new and approved product details. It also exposes students to InSight commitment tracking and electronic notification functionality.

Topics Include • • • •

•

Creating product data Creating templates for regulatory objective records (Events) Creating and maintaining a project to track applications and regulatory objectives Creating and managing package set registrations

•

Managing changes to product details Tracking commitments and correspondence and creating electronic alerts

Audience •

Managers and executives needing a high-level overview to InSight Registration functionality.

Prerequisites  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of Microsoft Internet Explorer 7.0 or higher. Duration/Pricing* Half Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$325

Uxbridge, UK €348

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

14

Liquent InSight® for Publishing

15

PUBLISHING WITH LIQUENT INSIGHT® FOR ECTD AND PAPER Course Description This three-day course will introduce students to the features of Liquent InSight in order to: • Understand and navigate to data in InSight Manager. • Create and modify assembly structures that will be used in projects in order to consume and contribute content. • Enter and edit metadata used in eCTD submissions. • Enter and edit publishing settings used in paper submissions. • Publish eCTD and paper submissions. • Manage the eCTD lifecycle.

Topics Include • • • • •

• • • •

eCTD Overview Navigating through InSight Manager Working With Applications Creating Assembly Trees Using InSight Wizards

Working with Special Data Inserting Hyperlinks Publishing Reviewing Published Output

Audience This course is designed to enable assemblers and publishers with the tools necessary to produce an eCTD and a paper submission. Participants are provided with a publishing approach that leverages faster assembly techniques and methods to track the lifecycle of the submission.

Prerequisites  Working knowledge of the CTD and eCTD Specifications.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Basic working knowledge of a document management system and/or file system – including the ability to: Save files, delete files, and navigate folder structures.  Working knowledge of Microsoft Internet Explorer 5.5 or higher.  Working knowledge of Adobe Acrobat, Microsoft Word/Excel or other word processing/spreadsheet applications. Duration/Pricing* Three Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$1950

Uxbridge, UK €2085

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

16

PUBLISHING WITH LIQUENT INSIGHT® FOR ECTD AND NEES Course Description This three-day course will introduce Publishers to the features of Liquent InSight in order to: • Understand and navigate to data in InSight. • Create and modify assembly structures that will be used in projects in order to consume and contribute content. • Enter and edit metadata used in eCTD submissions. • Publish eCTD submissions. • Publish a NeeS submission. • Manage the eCTD Lifecycle.

Topics Include • • • • • • •

• •

eCTD Overview Navigating through InSight Manager Working With Applications Creating Assembly Trees Using InSight Wizards Working with Special Data Inserting Hyperlinks

• • •

Creating Overlays and Variables Creating Electronic Table of Contents Publishing Reviewing Published Output Managing the eCTD Lifecycle

Audience • •

This course is designed to enable assemblers and publishers with the tools necessary to produce an eCTD and NeeS submission. Participants are provided with a publishing approach that leverages faster assembly techniques and methods to track the lifecycle of the submission.

Prerequisites  Working knowledge of the CTD and eCTD Specification.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Basic working knowledge of a document management system and/or file system – including the ability to: Save files, delete files, and navigate folder structures.  Working knowledge of Adobe Acrobat, Microsoft Word/Excel or other word processing/spreadsheet applications. Duration/Pricing* Three Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$1950

Uxbridge, UK €2085

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

17

PUBLISHING WITH LIQUENT INSIGHT® FOR PAPER Course Description This two-day course will introduce students to the features of Liquent InSight in order to: • Understand and navigate to data in InSight. • Create and modify assembly structures that will be used in projects in order to consume and contribute content. • Enter and edit publishing settings used in CTD submissions. • Publish CTD submissions.

Topics Include • • • • •

• • • •

CTD Overview Navigating through InSight Manager Working With Applications Creating Assembly Trees Using InSight Wizards

Working with Special Data Inserting Hyperlinks Publishing Reviewing Published Output

Audience This course is designed to enable assemblers and publishers with the tools necessary to produce a CTD submission. Participants are provided with a publishing approach that leverages faster assembly techniques of the submission.

Prerequisites  Working knowledge of the CTD Specification.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Basic working knowledge of a document management system and/or file system – including the ability to: Save files, delete files, and navigate folder structures.  Working knowledge of Microsoft Internet Explorer 5.5 or higher.  Working knowledge of Adobe Acrobat, Microsoft Word/Excel or other word processing/spreadsheet applications. Duration/Pricing* Two Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$1300

Uxbridge, UK €1390

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

18

REPORT LEVEL PUBLISHING WITH LIQUENT INSIGHT® Course Description This two-day course will introduce Publishers to the features of Liquent InSight in order to: • Understand and navigate to data in InSight. • Create and modify assembly structures that will be used in projects in order to consume and contribute content in Modules 4 and 5. • Enter and edit metadata used in report level publishing. • Publish reports to paper and electronic output channels.

Topics Include • • • • •

• • • • •

Report Publishing Overview Navigating through InSight Manager Managing Standalone Assemblies Creating Assembly Trees Using InSight Wizards

Working with Special Data Applying Overlays and Variables Creating Tables of Content Publishing Clinical Study Reports Reviewing Published Output

Audience • •

This course is designed to enable assemblers and report level publishers with the tools necessary to produce reports. Participants are provided with a publishing approach that leverages faster assembly techniques and methods to create study reports.

Prerequisites  Working knowledge of the CTD and eCTD Specification.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Basic working knowledge of a document management system and/or file system – including the ability to: Save files, delete files, and navigate folder structures.  Working knowledge of Adobe Acrobat, Microsoft Word/Excel or other word processing/spreadsheet applications. Duration/Pricing* Two Day Class

Horsham, PA (USA)

Classroom Training

$1300

Uxbridge, UK €1390

Onsite Training Please call for pricing and scheduling information *Prices will be charged in the local currency of the training venue, and may be subject to taxes.

19

ADVANCED PUBLISHING WITH LIQUENT INSIGHT® Course Description This one-day course is designed to present publishers with the knowledge necessary to perform sophisticated publishing tasks for eCTD creation. Participants are provided with an advanced approach to managing concurrently planned sequences, lifecycle applications, and regional submission variances. This course approach offers experienced publishers new techniques for faster assembly creation and alternative methods to tracking the lifecycle of a submission. This course will introduce students to the advanced features of Liquent InSight in order to: • Create and manage assembly templates with variables. • Define special XML metadata types. • Build and support a Structured Product Labeling (SPL) folder for US and Product Information Management (PIM) for EU submissions. • Create and modify study reports including Study Tagging Files (STF) • Manage multiple planned sequences in an eCTD lifecycle. • Understand lifecycle linking and retarget broken and historical links.

Topics Include • • • •

• • • •

Automating Assemblies Changing Assembly Extensions Labeling Creating Study Reports

Creating Templates with Variables Preparing Assemblies in the Lifecycle Lifecycle Linking Final Project

Audience •

Liquent InSight Publisher Assembler Users/Publishers.

Prerequisites  Attendance in Publishing with Liquent InSight or What’s New with Publishing with Liquent InSight.  3-6 months prior practical application of the product.  Working knowledge of the CTD and eCTD specification.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of Adobe Acrobat, Microsoft Word/Excel or other word processing/spreadsheet applications. Duration/Pricing* One Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$650

Uxbridge, UK €695

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

20

LIQUENT INSIGHT® ADMINISTRATION FOR PUBLISHERS Course Description This one-day course will introduce administrators to the system features of Liquent InSight in order to: • Understand the role of an InSight Publisher Administrator. • Configure security for Users and Groups. • Assign values in Data Administration. • Create and troubleshoot error messages in the publishing log. • Understand system settings on the Rendering and Publishing server. • Describe the system architecture of the suite. • Understand content types.

Topics Include • • • • •

•

Architecture Overview Security Administration Data Administration Technical Administration Administration Reporting

• •

LES Rendering and Publishing Services Administrator Resources Troubleshooting

Audience • •

InSight Publisher Administrators. IT staff/LAN Administrators.

Prerequisites  Attendance in the following course: Publishing with Liquent InSight.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Basic working knowledge of a document management system and/or file system – including the ability to: Save files, delete files, and navigate folder structures.  Working knowledge of Microsoft Internet Explorer 5.5 or higher.  Working knowledge of Adobe Acrobat, Microsoft Word/Excel or other word processing/spreadsheet applications. Duration/Pricing* One Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$650

Uxbridge, UK €695

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

21

WHAT’S NEW WITH PUBLISHING WITH LIQUENT INSIGHT® Course Description This interactive one-day course will introduce students to the new features of Liquent InSight Publisher in order to: • Create and modify regional submissions using the eCTD wizard. • Understand and use Liquent SmartLink for in-process linking. • Use the Link Inspector reporting tool to manage broken, historical and valid links. • Prepare dossiers for publishing by utilizing quality assurance features. • Publish and review eCTD submissions with Conformity Checker.

Topics Include • • • •

• • • •

Course Introduction & Overview Utilizing eCTD Wizard In-Process Linking - Keywords Link Reporting

Creating Paper Reference Leafs Publishing New Table of Content Functionality Reviewing an eCTD

Benefits This one-day class will introduce students to the new features and functionality of Publishing with Liquent InSight. Upon completion of the course, publishers will be able to effectively take advantage of these new features. Benefits include faster linking techniques, multiple reporting methods to address link status, enhanced eCTD creation wizards for ICH regions, updated prepublishing review functionality and eCTD conformity tools, the creation of paper reference leafs, and support of multiple document management systems.

Audience •

Liquent InSight Submission Publishers.

Prerequisites  Attendance in the course Publishing with Liquent InSight.  Working knowledge of the Microsoft Windows XP or Windows 2003 interface.  Working knowledge of Microsoft Word. Duration/Pricing* One Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$650

Uxbridge, UK €695

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

22

REVIEWING SUBMISSIONS WITH LIQUENT INSIGHT® FOR VIEWING Course Description This half-day course will introduce students to the features of Liquent InSight for Viewing in order to: • Create and manage user accounts, data repositories and application groups for the purpose of searching for and reviewing CTD and Non-eCTD submissions. • Search for and review CTD and/or Non-eCTD submissions as well as implement commenting. • Run reports within Liquent InSight for Viewing.

Topics Include Part One – The Administrative Role • Managing Users, Data Repositories and Application Groups. • Managing and Registering eCTD & Non-eCTD Applications. • Content Indexing. • Managing User Groups & Assigning Applications to Groups. • Viewing Server Configurations. Part Two – The Reviewer Role • Searching for Submissions – Content vs. Metadata. • Reviewing the Submission’s Table of Contents, Document Properties and Lifecycle. • Creating, Responding to, and Closing Comments • User Settings & Preferences • Running& viewing Reports: Comments, Review matrix by User and Auto Registration.

Audience The first half of this course is designed to instruct administrators on how to assign and establish permissions for reviewers of eCTD and Non-eCTD submissions. The second half of this course instructs users on how to access and view the eCTD and Non-eCTD submissions.

Prerequisites  Working knowledge of Microsoft Windows® – including the ability to: Start an application; close/exit an application; open, close, minimize and move windows; and switch between applications and tasks.  Working knowledge of Microsoft Internet Explorer 7.0 or higher. Duration/Pricing* Half Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$325

Uxbridge, UK €348

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

23

PUBLISHING WITH LIQUENT INSIGHT® CERTIFIED PROFESSIONAL EXAM PREPARATION COURSE Course Description The purpose of this one-day Review class is to assist you in your preparation for the Publishing with Liquent InSight Certified Professional Examination. At the beginning of each lesson, you will complete a skills analysis checklist. This analysis will be used to focus the lessons for each topic. During the class, you will be asked questions to measure your knowledge of publishing. In addition, you will have the opportunity to practice your publishing skills with hands-on exercises using Liquent InSight. The major topics included in the review are listed below. Since instruction will cover publishing topics from training courses, you may want to bring your training manuals from the following classes: Publishing with Liquent InSight.

Topics Include • • • • • •

• • • • • •

InSight Entity Relationships Navigation Working with Applications Creating Assembly Trees Assigning Documents Creating Special Sheets

Defining Overlays and Variables Building Tables of Contents In-Process Linking Publishing Reviewing a Publication Managing the eCTD Lifecycle

Audience •

Submission Publishers.

Certified Liquent InSight Publishers are individuals who have demonstrated mastery in skills necessary to utilize Liquent solutions. Liquent InSight Publisher certification helps companies identify experts who know how to use this powerful publishing tool to the best of their advantage; and provides publishers with the framework necessary to distinguish themselves as leaders in their industry.

Prerequisites  3-6 months of full-time Liquent InSight Publisher use; versions 3.6 and above.  Attendance in the course Publishing with Liquent InSight. Duration/Pricing* One Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$650

Uxbridge, UK €695

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

24

PUBLISHING WITH LIQUENT INSIGHT® CERTIFIED PROFESSIONAL EXAM Course Description The Certified Publishing with Liquent InSight examination consists of two parts that are taken on the same day. The first part is a written exam, in which the student will answer questions about using the Liquent InSight system. Included in this section will be basic Liquent InSight publishing scenarios, matching, true/false and multiple-choice questions. The second part is a practical exam, in which the student will create an eCTD and CTD submission using the following as reference materials: provided source documents and electronic copies of required output. Please Note: Unless provided by the instructor, no paper or electronic study aids will be available for use during either part of the examination.

Topics Include • • • • • •

• • • • • •

InSight Entity Relationships Navigation Working with Applications Creating Assembly Trees Assigning Documents Creating Special Sheets

Defining Overlays and Variables Building Tables of Contents In-Process Linking Publishing Reviewing a Publication Managing the eCTD Lifecycle

Audience •

Submission Publishers.

Certified Liquent InSight Publishers are individuals who have demonstrated mastery in skills necessary to utilize Liquent solutions. Publishing with Liquent InSight certification helps companies identify experts who know how to use this powerful publishing tool to the best of their advantage; and provides publishers with the framework necessary to distinguish themselves as leaders in their industry.

Prerequisites • •

3-6 months of full-time Publishing with Liquent InSight; versions 3.6 and above. Attendance in the course Publishing with Liquent InSight.

Duration/Pricing* One Day Exam

Horsham, PA (USA)

Classroom Training Onsite Training

$395

Uxbridge, UK €465

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

25

Liquent S-Cubed®

26

PUBLISHING WITH LIQUENT S-CUBED ECTD AND NONECTD® Course Description This two-day course will introduce students to the features of Liquent S-Cubed in order to: • Successfully navigate throughout the Liquent S-Cubed application. • Create and manage eCTD and Non-eCTD applications and submissions. • Compiling eCTD and Non-eCTD submissions. • Perform PDF editing functions that help enable documents to meet regulatory compliancy. • Successfully publishing, validating and downloading eCTD and Non-eCTD submissions. • Work within the product lifecycle of eCTD submissions • Migrate and clone legacy CTD submissions into S-Cubed

Topics Include • • • • • • • • • • • •

Navigating the Liquent S-Cubed Workspace Creating and Editing Applications and Submissions Adding, Editing and Removing Documents Managing Study Reports (STF) and creating sites – Per US Students Working with Node Extensions – Per EU Students PDF Editing Publishing, Validating, Locking and Downloading the Submissions Creating Subsequent Submissions and Modifying TOC Content The TOC Views and Viewing Document Metadata Searching for Submissions and Saving Search Criteria Importing and Cloning Submissions Running Reports, The Audit Trail and Setting User Preferences

Audience This course is designed to instruct Submission Managers and Publishers on creating and supporting their electronic submission processes. For Submission Managers, this course also instructs how to migrate legacy content into their Liquent S-Cubed environment.

Prerequisites  Working knowledge of the CTD Specification.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Basic working knowledge of a document management system and/or file system – including the ability to: Save files, delete files, and navigate folder structures. Duration/Pricing* Two Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$1300

Uxbridge, UK €1390

Please call for pricing and scheduling information

27

PUBLISHING WITH LIQUENT S-CUBED®: PUBLISHER FOR PAPER Course Description This one-day course will introduce students to the features of Liquent S-Cubed: Publisher in order to: • Understand and navigate to data in Liquent S-Cubed: Publisher. • Manage eCTD and NeES submissions for the purpose of paper dossier publishing. • Establish and manage dossier settings. • Manage paper dossier volumes and their documents. • Publish dossier volumes.

Topics Include • • • • • • • •

•

Navigating the Workspace Loading and Modifying Applications and Submissions Creating and Modifying Dossiers Configuring Dossier Settings: Volume/Document/Table of Contents Creating, Modifying and Applying Dossier Templates Locking and Unlocking Dossiers Navigating the Dossier Preview Window Renaming and Removing Dossier Volumes

• • • • • •

Viewing and Fixing Overlapping Headers and Footers Applying Headers, Footers and Pagination Splitting, Merging, Moving and Removing Documents Working with Tab Pages, Slip Sheets and Cover Pages Publishing Dossiers and Configuring Publishing Settings Downloading Published Dossiers Working with NeeS Submissions – Applicable only to those customers using NeeS Submissions

Audience This course is designed to instruct publishers on reusing their electronic submissions for paper dossiers.

Prerequisites  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of Microsoft Internet Explorer 5.5 or higher.  Working knowledge of Adobe Acrobat. Duration/Pricing* One Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$650

Uxbridge, UK €695

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

28

PUBLISHING WITH LIQUENT S-CUBED: NON-CTD & REPORT LEVEL PUBLISHING (RLP)® Course Description This two-day course will introduce students to the features of Liquent S-Cubed in order to: • Successfully navigate throughout the Liquent S-Cubed application. • Create and manage Non-CTD templates, applications and submissions. • Perform various PDF editing functions within Liquent S-Cubed Non-CTD. • Publishing, validating and downloading Non-CTD submissions. • Create study reports through the use of pre-defined or user-defined templates. • Import Non-CTD legacy submissions.

Topics Include • • • • • • • • • • • • •

Working with S-Cubed and navigating the S-Cubed Workspace Creating and Editing S-Cubed: Non-CTD Applications Creating and Editing S-Cubed: Non-CTD Submissions Managing Non-CTD Templates Compiling Non-CTD Submissions Viewing Document Metadata PDF Editing Publish, Validate, Lock and Download Submissions Search for Non-CTD Submissions Importing Submissions: CTD to Non-CTD / Non-CTD to Non-CTD Report Level Publishing (RLP) Searching for Submissions and Saving Search Criteria Setting User Preferences

Audience This course is designed to instruct Submission Managers and Publishers on creating and supporting their electronic submission processes.

Prerequisites  Working knowledge of the CTD Specification.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Basic working knowledge of a document management system and/or file system – including the ability to: Save files, delete files, and navigate folder structures. Duration/Pricing* Two Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$1300

Uxbridge, UK €1390

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

29

PUBLISHING WITH LIQUENT S-CUBED: CTD, NON-CTD & REPORT LEVEL PUBLISHING (RLP)® Course Description This three-day course will introduce students to the features of Liquent S-Cubed: CTD/NonCTD/RLP in order to: • Successfully navigate throughout the Liquent S-Cubed application. • Create and manage CTD/Non-CTD/RLP applications and submissions. • Compiling CTD/Non-CTD/RLP submissions. • Perform PDF editing functions that enable documents to meet regulatory compliancy. • Successfully publish, validate and download CTD/Non-CTD/RLP submissions. • Work within the product lifecycle of eCTD submissions. • Import and clone CTD and Non-CTD legacy submissions.

Topics Include • • • • • • • • • • • • •

Navigating the Liquent S-Cubed Workspace Creating and Editing CTD and Non-CTD Applications and Submissions Creating and Managing Non-CTD and Report Level Publishing (RLP) Templates Adding, Editing and Removing Documents / Working with Placeholders Managing Study Reports (STF) and creating sites – Per US Students Working with Node Extensions – Per EU Students PDF Editing Publishing, Validating, Locking and Downloading CTD and Non-CTD Submissions Creating Subsequent Submissions, Modifying TOC Content and Viewing Document Metadata Report Level Publishing (RLP) Searching for Submissions and Saving Search Criteria Importing and Cloning CTD Submissions / Importing Non-CTD Submissions Running Reports, The Audit Trail and Setting User Preferences

Audience This course is designed to instruct Submission Managers and Publishers on creating and supporting their electronic submission processes.

Prerequisites  Working knowledge of the CTD Specification.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Basic working knowledge of a document management system and/or file system – including the ability to: Save files, delete files, and navigate folder structures. Duration/Pricing* Three Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$1950

Uxbridge, UK €2085

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

30

LIQUENT S-CUBED®: PUBLISHER ADMINISTRATOR CONSOLE Course Description This two-hour course will introduce students to the features of Liquent S-Cubed: Publisher Administrator Console in order to: • Obtain and manage Liquent S-Cubed: Publisher server information. • Establish policies. • Create and manage user accounts for non-LDAP environments. • Obtain and manage license information. • Manage central repositories and application groups. • Establish Group or Application Level security. • Configure server settings and establish log file locations.

Topics Include • • • • •

•

The Liquent S-Cubed Administrator Console Home Page Password and Timeout Settings Create and Modify User Accounts Licensing Defining and Managing Datastores

• • • •

Defining and Managing Application Groups Configuring Database, LDAP and SMTP settings Configuring Log File Locations Running Administrative Reports Managing Cover Pages

Audience This course is designed to instruct S-Cubed: Publisher Administrators on the processes of creating user accounts and groups and managing Datastores and Applications.

Prerequisites  Working knowledge of application servers.  Working knowledge of establishing application securities and policies. Duration/Pricing* 2 Hour Class

Horsham, PA (USA)

Uxbridge, UK

Delivered after S-Cubed: eCTD

Classroom Training Onsite Training

$162.50

€173.75

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

31

DOCUMENT AUTHORING WITH LIQUENT S-CUBED®: TEMPLATES Course Description This half-day course will introduce Medical Writers and Regulatory Affairs Specialist to the features of Liquent S-Cubed Templates in order to: • Effectively author documents based on the Common Technical Document (CTD), Clinical Trail Application (CTA) and Investigational New Drug (IND) formats. • Focus on content rather than formatting.

Topics Include • • • • •

•

Accessing Liquent S-Cubed Templates and Understanding the Toolbar Document Styles Working with Tables and Figures Managing Page Settings Working with Unformatted Text

• • • •

Creating Cross References and Hyperlinks Creating and Modifying Custom Properties Creating and Updating Hierarchical Tables Applying and Removing Guidance and Instructional Text Running the Styles Report

Audience This course is designed to instruct students on preparing Regulatory-structured and compliantsubmission documents thus reducing the time manual formatting requires.

Prerequisites  Intermediate skills in Microsoft Word.  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of the Common Technical Document (CTD), Clinical Trail Application (CTA) and Investigational New Drug (IND) formats. Duration/Pricing* Half Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$325

Uxbridge, UK €347.50

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

32

LIQUENT S-CUBED®: ADMINISTRATOR CONSOLE Course Description This two-hour course will introduce students to the features of Liquent S-Cubed: eCTD Administrator Console in order to: • Obtain and manage Liquent S-Cubed: eCTD / NeES server information. • Establish server policies. • Create and manage user accounts for non-LDAP environments. • Obtain and manage license information. • Manage central repositories and application groups. • Establish Group or Application Level security. • Configure server settings and establish log file locations. • Manage Content and Cache locations. • Establish eDMS binding settings for those using Documentum.

Topics Include • • • • • •

•

The S-Cubed Administrator Console Home Page Password and Timeout Settings Create and Modify S-Cubed User Accounts Licensing and Installed Options Defining and Managing Datastores Defining and Managing Application Groups

• • • • •

Creating User Groups & User Group Assignments Configuring Database, LDAP and SMTP settings Configuring Log File Locations Indexing Submission Content Creating & Updating Cache Files Managing eDMS Binding Rules – Covered only if Documenum and eDMS Binding are configured

Audience This course is designed to instruct administrators on the processes of creating user accounts and groups and managing Datastores and Applications.

Prerequisites  Working knowledge of application servers.  Working knowledge of establishing application securities and policies. Duration/Pricing* 2 Hour Class

Horsham, PA (USA)

Uxbridge, UK

Delivered after Liquent S-Cubed: eCTD

Classroom Training Onsite Training

$162.50

€173.75

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to

33

WHAT’S NEW IN LIQUENT S-CUBED® VERSION 5.0 Course Description This interactive one-day course will introduce existing S-Cubed users to the latest features of Liquent S-Cubed Version 5.0 in order to: • Leverage the new application concepts, features and enhancements. • Instruct Administrators on the enhanced functionalities managing source DMS and Datastores. • Introduce students to InSight GateKeeper for validating their eCTD and Non-eCTD submissions.

Topics Include • • • • • • • •

Working with Single Assemblies: CTD vs. Non-CTD & eCTD vs. Non-eCTD Lock/Unlock by Module Re-order Studies within the submission Establish a Source DMS and Manage Datastores Working with ‘Planned Sequences’ Run the Publish Progress and Where Used Reports Validate submissions in InSight GateKeeper End of Class Project

Audience This course is designed to enable existing S-Cubed Submission Managers, Publishers and Administrators on creating and supporting their electronic submission processes while leveraging the latest features implemented in S-Cubed version 5.0.

Prerequisites  Working knowledge and previous hand-on experience utilizing S-Cubed: eCTD and/or NeeS version 4.3.x or higher.  Working knowledge of Microsoft Windows® – including the abilty to: Start an application; close/exit an application; open, close, minimize, maximize and move windows; and switch between applications and tasks.  Basic working knowledge of a document management system and/or file system – including the abilty to: save files, delete files, and navigate folder structures. Duration/Pricing* One Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$650

Uxbridge, UK €695

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

34

Liquent SmartDesk®

35

AUTOMATING THE PUBLISHING PROCESS WITH LIQUENT SMARTDESK FOR PDF® Course Description This interactive one-day course will introduce students to the features of Liquent SmartDesk for PDF in order to: • Automate the publishing process, and help address PRD-publishing challenges in a simple and streamlined manner. • Effectively perform QC and management • Mitigate long periods of time manually fixing broken links and bookmarks.

Topics Include • PDF Security • PDF Optimization • PDF Page Verification – Margins, orientation & content • Splitting & Merging PDF Files • Scaling & Redacting PDF Files • PDF Page Stamping – Header/Footers and Link Referencing • PDF Link Tools

• Reversing Bookmark Order & Cloning Bookmarks • Importing/Exporting Links & Bookmarks • Linking the Table of Contents • Modifying magnification Settings • Verification & Resolution Tools for Document Information Fields, Navigational Items & Font Information

Audience This course is designed to instruct regulatory team members on preparing PDF documents in accordance with regulatory requirements before compiling an electronic submission.

Prerequisites  Working knowledge of Microsoft Windows® - including the ability to Start an application; close/exit and application; open, close, minimize, maximize and move windows; and switch between applications and tasks.  Working knowledge of the ICH Guidelines.  Working knowledge of Adobe Acrobat. Duration/Pricing* One Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$650

Uxbridge, UK €695

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

36

REVIEWING SUBMISSIONS WITH LIQUENT eCTD VIEWER WEB EDITION® Course Description This half-day course will introduce students to the features of Liquent eCTDViewer Web Edition in order to: • Create and manage user accounts, data repositories and application groups for the purpose of searching for and reviewing eCTD and NeeS submissions. • Search for and review eCTD and/or NeeS submissions as well as implement commenting. • Run reports within Liquent eCTDViewer Web Edition.

Topics Include • • • • • • • • • • • • • • • •

Part One – The Administrative Role: Adding, Editing and Deleting Users. Adding, Editing and Deleting Application Groups. Adding, Editing and Deleting Data Repositories. Registering, Editing and Deleting eCTD and NeeS Applications. Content Indexing. Adding a User Group. Assigning Users and eCTD and/or NeeS Applications to a User Group. Editing and Deleting User Groups. Viewing Server Configuration Settings. Part Two – The Reviewer Role: Searching for Submissions – Content vs. Metadata. Reviewing the Submission’s Table of Contents, Document Properties and Lifecycle. Creating, Responding to, and Closing Comments. eCTDViewer User Settings. Running and Viewing Reports: Comments, Review Matrix by User and Auto Registration

Audience The first half of this course is designed to instruct administrators on how to assign and establish permissions for reviewers of eCTD and NeeS submissions. The second half of this course instructs users on how to access and view the eCTD and NeeS submissions.

Prerequisites  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of Microsoft Internet Explorer 5.5 or higher. Duration/Pricing* Half Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$325

Uxbridge, UK €347.50

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

37

VALIDATING SUBMISSIONS WITH LIQUENT eCTD GATEKEEPER® Course Description This half-day course will introduce user to the features of Liquent eCTD GateKeeper in order to: • Effectively mitigate risks when validating eCTD submissions. • Successfully perform a complete or customized validation based on fully compliant validation rules.

Topics Include • • • •

•

Introduction to Liquent eCTD GateKeeper Accessing and Navigating Liquent eCTD GateKeeper Working on the Submissions Tab Working on the Validation Criteria Tab

• •

Accessing and Interpreting the Validation Report Working with Subsequent Submissions Working on the Preferences Tab

Audience This course is designed to instruct students on validating eCTD submissions via Liquent eCTD GateKeeper.

Prerequisites  Working knowledge of Microsoft Windows – including the ability to: Start an application; close/exit an application; open, close, minimize, maximize, and move windows; and switch between applications and tasks.  Working knowledge of the ICH Guidelines. Duration/Pricing* Half Day Class

Horsham, PA (USA)

Classroom Training Onsite Training

$325

Uxbridge, UK €347.50

Please call for pricing and scheduling information

*Prices will be charged in the local currency of the training venue, and may be subject to taxes.

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Liquent Learning Network

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Overview The Liquent Learning Network is Liquent’s eLearning solution. The Liquent Learning Network is an easy to use client interface that gives you access to personalized, self-service learning programs and a learner-searchable catalog of learning resources. These learning resources provide a host of courses with multiple delivery styles including self-paced, online, live courses, assessments, surveys, and recorded events. The Liquent Learning Network leverages Geo Learning as the platform for Liquent’s Learning Management System. This tool enables easy access to recorded webcasts and self-paced online courses. Benefits of the Liquent Learning Network include: • Users can learn at their own computer, without leaving the work site. • Training may be completed in bite-size chunks, when and where it is needed. • eLearning satisfies the training needs of a geographically dispersed workforce, without large investments in travel and living expenses. • Training can be completed at the learner’s own pace. • Interactive training activities allow users to develop and practice skills easily. • Learners receive a consistent message regardless of when or where they access training.

Course Offerings The Liquent Learning Network currently offers packages of courses, and individual courses. Course packages are designed by series and include an instructional plan that navigates student development. Individual courses are also available for learners who wish to personalize their learning experience to a specific component or unit of instruction. All courses and packages are accessible to the student within a certain time period; depending on the course selection the time period can range from 30 days to 120 days.

Custom Development Liquent can customize your eLearning experience by designing courses for your business. Custom course development is available for all delivery styles including self-paced online modules, blended live and online courses, and webcasts with supplemental student materials. Custom courses can be deployed in your environment through the following accessibility points: HTML, CD, AICC, SCORM 1.2 or single file executable. Custom courses can also be delivered privately on the Liquent Learning Network solely for your learner base. To inquire about custom development opportunities, please contact [email protected].

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EDUCATION AND REGISTRATION INFORMATION Registration To register for any of our classes, go to http://www.liquent.com/sites/default/files/do wnloads/education-regform.pdf

215.347.1803. PDF copies of the hotel information and local restaurants are located on our web site http://w ww.liquent.com/training Class Cancellations Course fees are refundable with at least 10 business days notice prior to start of class. Other cancellations are subject to a 50% cancellation fee. Cancellations must be emailed directly to [email protected], or faxed to us at 215.328.4360. We cannot accept verbal cancellations.

If you have any questions, feel free to email us or call us at 215.347.1803. Email Registration: [email protected]

Fax Registration: 215.328.4360 Payment Classes may be paid for using your credit card, check or by invoice. The price charged will be in the currency of the training location, and may be subject to local taxes. If you would prefer to be invoiced, we require a purchase order number.

Liquent reserves the right to cancel any training course due to insufficient enrollment or other events beyond our control by providing notice at least 5 business days prior to scheduled start date. The client understands and agrees that Liquent shall not, in any way, be held responsible for any costs, including loss of airfare or other transportation, hotel costs, or any other expenses incurred.

Mail Payment: US Check Remittance Address Liquent Inc. 62995 Collection Center Dr. Chicago, IL 60693-0629 UK Check Remittance Address Liquent Limited JP Morgan Chase Bank N.A. 125 London Wall London EC2Y 5AY

Certificate of Completion Upon fulfillment of class requirements you will receive a Certificate of Completion. Class times Classes are held from 9:00am until 4:00pm. We will be unable to issue an official Certificate of Completion if you choose to leave before the end of the class.

Where will training be held? Training will be held in Liquent’s Education Centers in Horsham, Pennsylvania (suburban Philadelphia), or at our European location in Uxbridge, United Kingdom.

Questions? If you have any questions, call us at 215.347.1803 or send an email to [email protected].

How will I know if my faxed registration is received? You should receive an email confirmation of your faxed registration within two business days. If you have not, please contact us at

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