LIQUENT Education Services Course CatalogGroup training allows companies to schedule an entire...

LIQUENT Education Services

Course Catalog 2016

LIQUENT Education Services Course Catalog

Course Number:............................................................................. CC

Course Edition: .............................................................................. 2016

For software version: ..................................................................... Var

Published:....................................................................................... 01/16

This document, as well as the software described in it, is provided under a software license agreement with LIQUENT, Inc., a PAREXEL International Company. 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 © 2004–2015 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 the Rights in Technical Data and Computer Software clause at DFARS 25.227-7102 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 Inc., 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, S-Cubed: 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.

I

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 ................................................................................................. 8

Course Description ...................................................................................................................... 8

Topics Include .............................................................................................................................. 8

Audience ...................................................................................................................................... 8

Prerequisites ................................................................................................................................ 8

Liquent InSight® for Registration for Medical Device Users ........................................................... 9

Course Description ...................................................................................................................... 9

Topics Include .............................................................................................................................. 9

Audience ...................................................................................................................................... 9

Prerequisites ................................................................................................................................ 9

Liquent InSight® Product Detail Management ............................................................................. 10

Course Description .................................................................................................................... 10

Topics Include ............................................................................................................................ 10

Audience .................................................................................................................................... 10

Prerequisites .............................................................................................................................. 10

Liquent InSight® Advanced Planning & Tracking......................................................................... 11


Topics Include ............................................................................................................................ 11

Audience .................................................................................................................................... 11

II

Prerequisites .............................................................................................................................. 11

Administering the Liquent InSight® Suite ...................................................................................... 12


Topics Include ............................................................................................................................ 12

Audience .................................................................................................................................... 12

Prerequisites .............................................................................................................................. 12

Liquent InSight® for Commitments & Correspondence ............................................................... 13


Topics Include ............................................................................................................................ 13

Audience .................................................................................................................................... 13

Prerequisites .............................................................................................................................. 13

Liquent InSight® for European Union Applications ...................................................................... 14


Topics Include ............................................................................................................................ 14

Audience .................................................................................................................................... 14

Prerequisites .............................................................................................................................. 14

Executive Overview for Liquent InSight® for Registrations ................................... 15


Topics Include ............................................................................................................................ 15

Audience .................................................................................................................................... 15

Prerequisites .............................................................................................................................. 15

Publishing with Liquent InSight® for eCTD and Paper ................................................................. 18


Topics Include ............................................................................................................................ 18

Audience .................................................................................................................................... 18

Prerequisites .............................................................................................................................. 18

Publishing with Liquent InSight® for eCTD and NeeS .................................................................. 19


Topics Include ............................................................................................................................ 19

Audience .................................................................................................................................... 19

Prerequisites .............................................................................................................................. 19

Publishing with Liquent InSight® for Paper ................................................................................... 20


Topics Include ............................................................................................................................ 20

Audience .................................................................................................................................... 20

Prerequisites .............................................................................................................................. 20

Report Level Publishing with Liquent InSight® ............................................................................. 21

III


Topics Include ............................................................................................................................ 21

Audience .................................................................................................................................... 21

Prerequisites .............................................................................................................................. 21

Advanced Publishing with Liquent InSight® .................................................................................. 22


Topics Include ............................................................................................................................ 22

Audience .................................................................................................................................... 22

Prerequisites .............................................................................................................................. 22

Liquent InSight® Administration for Publishers ............................................................................. 23


Topics Include ............................................................................................................................ 23

Audience .................................................................................................................................... 23

Prerequisites .............................................................................................................................. 23

What’s New with Publishing with Liquent InSight® ....................................................................... 24


Topics Include ............................................................................................................................ 24

Benefits ...................................................................................................................................... 24

Audience .................................................................................................................................... 24

Prerequisites .............................................................................................................................. 24

Reviewing Submissions with Liquent InSight® for Viewing ......................................................... 25


Topics Include ............................................................................................................................ 25

Audience .................................................................................................................................... 25

Prerequisites .............................................................................................................................. 25

Publishing with Liquent InSight® Certified Professional Exam Preparation Course ..................... 26


Topics Include ............................................................................................................................ 26

Audience .................................................................................................................................... 26

Prerequisites .............................................................................................................................. 26

Publishing with Liquent InSight® Certified Professional Exam ..................................................... 27


Topics Include ............................................................................................................................ 27

Audience .................................................................................................................................... 27

Prerequisites .............................................................................................................................. 27

Automating the Publishing process with Liquent Smartdesk for PDF® ........................................ 28


IV

Topics Include ............................................................................................................................ 28

Audience .................................................................................................................................... 28

Prerequisites .............................................................................................................................. 28

Validating Submissions with Liquent InSight Validator® ............................................................... 29


Topics Include ............................................................................................................................ 29

Audience .................................................................................................................................... 29

Prerequisites .............................................................................................................................. 29

Liquent InSight for Analytics® ....................................................................................................... 30


Topics Include ............................................................................................................................ 30

Audience .................................................................................................................................... 30

Prerequisites .............................................................................................................................. 30

Liquent InSight for XEVMPD®....................................................................................................... 31


Topics Include ............................................................................................................................ 31

Audience .................................................................................................................................... 31

Prerequisites .............................................................................................................................. 31

Liquent InSight Manager: Submission Planning & Tracking ......................................................... 32


Topics Include ............................................................................................................................ 32

Audience .................................................................................................................................... 32

Prerequisites .............................................................................................................................. 32

Duration/Pricing* ........................................................................................................................ 32

Overview .................................................................................................................................... 34

Course Offerings ........................................................................................................................ 34

Custom Development ................................................................................................................ 34

Education and Registration Information ........................................................................................ 35

1

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.

2

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.parexel.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.

mailto:[email protected]

http://www.parexel.com/

3

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].



4

REGISTERING FOR LIQUENT COURSES

Registration

Please register online at www.parexel.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.

http://www.parexel.com/


5

Module Acronym Key

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 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 SPT RPT PDM

Publishing with LIQUENT InSight for eCTD & Paper

* * *

Publishing with LIQUENT InSight for eCTD & NeeS * * *

Paper Publishing with LIQUENT InSight *

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

* * *

7

LIQUENT InSight® for Planning & Tracking

8

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) Uxbridge, UK

Classroom Training $975 €1043

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.

9

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


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



Duration/Pricing*





10

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


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



Duration/Pricing*

One Day Class Horsham, PA (USA) Uxbridge, UK




11

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.



Duration/Pricing*





12

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.



Duration/Pricing*





13

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.



Duration/Pricing*

Half Day Class Horsham, PA (USA) Uxbridge, UK




14

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 Event-Country 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.



Duration/Pricing*





15

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



Duration/Pricing*





17

LIQUENT InSight® for Publishing

18

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.


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) Uxbridge, UK




19

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.


Enter and edit metadata used in eCTD submissions.

Publish eCTD submissions.

Publish a NeeS submission.

Manage the eCTD Lifecycle.

Topics Include

eCTD Overview







Creating Overlays and Variables

Creating Electronic Table of Contents

Publishing


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.




Duration/Pricing*

Three Day Class Horsham, PA (USA) Uxbridge, UK




20

PUBLISHING WITH LIQUENT INSIGHT® FOR PAPER

Course Description

This two-day course will introduce students to the features of LIQUENT InSight in order to:



Enter and edit publishing settings used in CTD submissions.

Publish CTD submissions.

Topics Include

CTD Overview







Publishing


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.





Duration/Pricing*

Two Day Class Horsham, PA (USA) Uxbridge, UK




21

REPORT LEVEL PUBLISHING WITH LIQUENT INSIGHT®

Course Description

This two-day course will introduce Publishers to the features of LIQUENT InSight in order to:


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


Managing Standalone Assemblies




Applying Overlays and Variables

Creating Tables of Content

Publishing Clinical Study Reports


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





Duration/Pricing*





22

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.



Duration/Pricing*





23

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.





Duration/Pricing*





24

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 pre-publishing 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*





25

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.


Duration/Pricing*





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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


Assigning Documents

Creating Special Sheets

Defining Overlays and Variables

Building Tables of Contents

In-Process Linking

Publishing

Reviewing a Publication


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*


Classroom Training Please call for pricing and scheduling information

Please call for pricing and scheduling information



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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


Assigning Documents

Creating Special Sheets

Defining Overlays and Variables

Building Tables of Contents

In-Process Linking

Publishing

Reviewing a Publication


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) Uxbridge, UK

Classroom Training Please call for pricing and scheduling information

Please call for pricing and scheduling information



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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*





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VALIDATING SUBMISSIONS WITH LIQUENT INSIGHT VALIDATOR®

Course Description

This half-day course will introduce user to the features of LIQUENT InSight Validator 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 InSight Validator

Accessing and Navigating LIQUENT InSight Validator

Working on the Submissions Tab

Working on the Reviewer 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 InSight Validator

Prerequisites


Working knowledge of the ICH Guidelines.

Duration/Pricing*


Classroom Training $325 €347.50



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LIQUENT INSIGHT FOR ANALYTICS®

Course Description

This half-day course will introduce students to the features of LIQUENT InSight for Analytics in order to:

Understand how to access reports within InSight

Understand and use Dashboard reports

Run predefined reports

Modify predefined reports

Create an ad hoc report

Topics Include

Running reports from the InSight Analytics pane

Registration reports

Manipulating reports results

Navigating report results

Accessing Dashboard reports

Configuring Dashboards

Configuring Dashboard reports

Analytics Reporting

Introduction to Ad-hoc reports

My reports

Favorites

Audience

This course is designed to provide users with advanced reporting and metrics from LIQUENT InSight data, including the ability to build your own ad hoc reports.

Prerequisites



Duration/Pricing*





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LIQUENT INSIGHT FOR XEVMPD®

Course Description

This half-day course will introduce students to the features of LIQUENT InSight for XEVMPD in order to:

Understand where XEVMPD data elements are captured

Use the XEVMPD Submission Wizard

Use the XEVMPD Acknowledgement Wizard

Enter required supporting data in Data Administration

Topics Include

XEVMPD data entry requirements

Creation of the ,xml file for submission to the agency

Using the XEVMPD Submission Wizard

Using the XEVMPD Acknowledgement Wizard to enter information received from the agency in XML format

Data Administration requirements

Audience

This course is designed to instruct users on how to use InSight for XEVMPD to enter required XEVMPD data in InSight as well as submit the data and receive acknowledgement form the agencies.

Prerequisites



Duration/Pricing*





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LIQUENT INSIGHT MANAGER: SUBMISSION PLANNING & TRACKING

Course Description

This course will introduce students to the features of InSight Manager in order to: Understand and navigate to data in InSight Manager.

Create and modify assembly structures that will be used in projects.

Use InSight Manager tools to track the status and guide the production of a publishing project.

Topics Include

InSight Manager & Submission Planning and Tracking Overview


Creating National Applications

Creating Events and Sequences


Using the Wizards

European Applications

Manipulating Assembly Elements

Managing Commitments & Correspondence

Assembly Management

Automating Assembly Creation

Global Project Planning

Working with Reports

Querying InSight

Audience

Project Managers and “super users” who will be planning and tracking submission projects using InSight Manager.

Prerequisites


Working knowledge of Microsoft Windows




Duration/Pricing*





33

LIQUENT Learning Network

34

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.parexel.com/files/3013/9155/2495/Education_Services_Classroom_Training_Registration_Form_w_logo.pdf If you have any questions, feel free to email us or call us at 215.347.1803. Email Registration: perceptive-liquent-

[email protected]

Fax Registration: 215.599.3040 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.

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.

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 215.347.1803. PDF copies of the hotel information and local restaurants are located on our web site http://www.parexel.com/solutions/informatics/liquent-insig/liquent-educational-services/

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 perceptive-liquent-

[email protected], or faxed to us at 215.599.3040.. We cannot accept verbal cancellations. 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.

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.

Questions? If you have any questions, call us at 215.347.1803 or send an email to perceptive-

[email protected].

http://www.parexel.com/files/3013/9155/2495/Education_Services_Classroom_Training_Registration_Form_w_logo.pdf





http://www.parexel.com/solutions/informatics/liquent-insig/liquent-educational-services/

http://www.parexel.com/solutions/informatics/liquent-insig/liquent-educational-services/





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