SPL Use Case: Improving Compliance, Increasing Efficiencies, and Reducing Costs

Transcription

1 SPL Use Case: Improving Compliance, Increasing Efficiencies, and Reducing Costs Doris Sincak Project Supervisor Sanofi Disclaimers DIA 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 ) 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. Sanofi The views expressed in this presentation are my personal views and do not necessarily represent the views of Sanofi. Drug Information Association 2 1

2 Case Study Promotional Labeling 3 Situation New or updated labeling text provided to several internal stakeholders in a Word document Stakeholders converted the document into outputs for their needs (Print or electronic) Long lead time Many individuals manipulating document High potential of editing errors requiring extensive review and multiple reworks Physicians Labeling Rule (PLR) New requirements Font size Margins Numbering Higher potential for editing and compliance errors Required additional quality assurance checks Additional time and resources Reworks Longer lead time 4 2

3 Problem Various departments without regulatory expertise independently worked on converting the labeling text into outputs for printing and publishing with different external vendors resulting in: Significant costs Regulatory concerns Reworks Delays 5 Process Analysis: SWOT Strengths Utilizing SPL for all products Standardized output formats Infrastructure Weaknesses Lack of resources (i.e. time, budget, FTEs) Dl Delayed dimplementation i Inefficient and error prone output process Duplication of efforts Inconsistent information disseminated by internal stakeholders Opportunities Threats SPL/XML Technology Inconsistent product information Regulations Potential FDA compliance issues Future expansion of SPL usage Workforce in industry reducing Print on demand Cost reduction measures 3

4 Recommendation Converting the approved SPL into customized outputs based on internal stakeholder requirements will ensure changes are not made after the FDA approved labeling text is issued. Additionally the technology will increase compliance and control, improve efficiency, and reduce costs. 7 Process Development 8 4

5 Development Identified Requirements Output formats Validation Repository Identified Potential Solutions In house and vendor based solutions Performed formal vendor / product evaluations Selected a vendor based solution Cost Knowledge of regulatory requirements Part 11 compliant Quality Assurance procedures Expertise in SPL 9 Development Designed the framework Source approved XML Business Rules Templates Full Prescribing Information (PI) Brief Summary Medication Guide PPI Instructions for Use (IFU) Styles 27 layouts Output Formats PDF HTML Selectable Delivery Times Created an Order Management website Developed a Document Repository to host outputs Implementation, Validation Testing, and Training 10 5

6 Process Overview 11 Process Overview Approved SPL (T=Day 0) Order Submission (T=0) Order management website Order definition SPL source document Template (Full PI, Brief Summary, MedGuide, ) Style (Letter, Poster, Magazine, ) Format and Delivery New template or style Formatting by Vendor (T=0 to T=5) SPL/XML files converted Template Style Business rules Quality assurance Automated document comparison Proofread and layout check by publishing specialist Quality Review (T=5) Cursory check Dissemination (T=6) Print and web ready formats to stakeholders 12 6

7 Website Order Form Example 13 Brief Summary 7

8 Standard Letter HTML 16 8

9 Poster Size 17 Medication Guide 18 9

10 Outcomes Increased compliance and control Validated d machine process utilizing i SPL ensures desired d outputs are consistent with FDA approved labeling Significant improvement in efficiencies Single source for conversion 3 fold decrease in implementation time Reduction in reworks Significant reduction cost 80% cost reduction 19 Thank You! 20 10