Using etechnologies to Increase Efficiency and Quality in Regulatory Operations Tim Powell Submissions Management Global Regulatory Affairs Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 1
Agenda: Technologies Implemented Workflow Management Tool Submission Ready Components ectd Automation - Validators Remote Access Consistently High Workload Monthly Submissions 70 60 # of Submissions 50 40 30 20 10 0 Jan Feb 2009 Mar Apr May Jun Jul Aug 2007 Sep Month Oct Nov Dec 2007 2008 2009 2
Managing / Estimating Workload So on a yearly basis how do you keep track of >3,000 submissions >20,000 components And how do you answer questions like How many Type 1B Variations were submitted in 2008? Can you publish a Paediatric Investigation Plan in March? Workflow Management Tool A workflow, issue and submissions management tool was implemented to manage EU and US submissions Detailed down to individual component level Single click reports for dossier status, submission schedule etc. 3
ectd Submission Workflow Submission Specialists Plan Track Build Hyperlink QA/Review Validate Submit Report Sr. Management Authors / Strategists Sr. Management Submission Requests The tool facilitates the submission request process Visible to Submissions Management from the time of initial planning Allows for resource planning and shifting of workload Use of global staff Requests can be made remotely & submissions reviewed remotely Who has capacity? 4
Component Packages Enforces the ectd at the planning stage Structure: Placement of components in an ectd template Operators: Can be placed on each component Allows the requestor to enter / view all information on each component Component Packages 5
Transparency Savings Submissions are tracked (at the component level) and can be reported on in real-time Full use of Global Staff increase in productivity Metrics can be generated in a matter of minutes Time savings One central location to track all data 6
Savings - Increase in Productivity 100 3500 Headcount 90 80 70 60 50 40 30 20 10 0 Dec 06 Feb 07 Apr 07 Jun 07 Aug 07 Oct 07 Dec 07 Feb 08 Apr 08 Jun 08 Aug 08 Oct 08 Dec 08 3000 2500 2000 1500 1000 500 0 # Comp ponents Processe ed Submission Ready Components A Submission Ready Component (SRC) is a document ready to be built into an electronic submission Formatted according to Global Health Authority Requirements (fonts, links, etc.) Internal navigation added (bookmarks and hyperlinks) Granularity according to ICH & regional specifications 7
Submission Ready Components MS Word Templates Standard format and a single look and feel Designed to meet all agency requirements Content Shells Granularity according to ectd specifications Contain base text and guidance to guide the author Submission Ready Components Documentum Rendition Server Creates PDF links from internal Word links Creates bookmarks, including: List of Figures List of Tables Stores PDF rendition alongside word version in document repository 8
Submission Ready Components Reduced re-work in authoring / publishing Compone ent Rate of Return Enhanced Wyeth Renditions Services - WRS Enhanced Word Template SRC Support Wave 1 Training Programs Launched SME Level 2 Support SRC Support Wave 2 Ongoing Training Focused Vaccines & TO&PS training Change Management < 5% (R&D) 3Q06 4Q06 1Q07 2Q07 Converting to ectd Format Eliminates the need to print paper (for EU centralised procedure) Result Reduction in effort: Over 100 hours of time saved for a major dossier of 400 volumes 9
Converting to ectd Format Ease of review Will allow submission through an electronic portal (once available) Ability to clone submissions for other regions ectd Format 6-12 Weeks Old Manual Process US Submission EU Submission 2-4 Weeks ectd Cloning Process US Submission EU Submission 10
Automation: Validation Validators used to verify ectd and publishing parameters ectd file-naming conventions Folder structure conventions Checks for broken / absolute hyperlinks PDF properties (version, document info, etc.) Automation: Validation Eliminates the need to open each file Example of savings: 2 minutes to validate links/bookmarks in 1 PDF 2,620 PDF files = savings of >80 hours over the building of the submission Can configure it for different regional requirements 11
Remote Access Access to our US based publishing servers to perform navigation tasks Remote publishing sites utilise Citrix for bookmarking and hyperlinking Reduction in overall time spent working on documents of 25% THANK YOU! powellt6@wyeth.com 12