Frost & Sullivan Webinar: FDA Mandates XML


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Slides from a webinar hosted by Frost & Sullivan and sponsored by Quark on XML in pharma.

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Frost & Sullivan Webinar: FDA Mandates XML

  1. 1. The FDA Mandates XML Maximize Your Investments through Dynamic Publishing Thursday, November 5, 2009 11:00 AM ET / 8:00 AM PT In Cooperation With:
  2. 2. Welcome and Housekeeping Polling Questions To gauge audience response, please respond with the best suitable answer Please disable your pop-up blocker Q&A Send your questions by using the bottom portion of your eBroadcast console eBroadcast On-Demand A recording of this eBroadcast will be available at Giveaways All registrants will receive a $500 voucher toward any one of our upcoming Executive MindXchange events. 2
  3. 3. Giveaway Kindle 3
  4. 4. Today’s Presenters Mukul Krishna Bernie Coney Global Director, Digital Media Senior Regulatory Specialist Frost & Sullivan Pfizer Michele Cobham Richard Brandt Submissions Manager, Regulatory Affairs VP of Life Sciences Par Pharmaceutical Quark 4
  5. 5. Mukul Krishna Global Director, Digital Media Frost & Sullivan 5
  6. 6. What is Dynamic Publishing? Frost & Sullivan defines Dynamic Publishing as a value chain of software products that enable the creation, repurposing and publication, and delivery of content across a variety of medium. Content XML Multi-channel Generation Publishing Delivery Web services 6
  7. 7. Value Proposition of Dynamic Publishing • An automatic publishing process significantly reduces time and costs associated with traditional publishing methods • Repurposable XML content can be leveraged across multiple content channels • Dynamic Publishing drives accuracy and consistency, reducing both errors and the usage of non-compliant, unauthorized content • Content can be customized easily on a per customer basis 7
  8. 8. What are SPL and PIM? The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product information. Product Information Management (PIM) is a project that was initiated in 1999 to develop a new way of handling product information. Its membership has been drawn from EMEA, Member State competent authorities and EFPIA members. It has gone through several phases, which have culminated in the publication of the PIM standard. 8
  9. 9. Challenges Faced by Pharmaceuticals Companies • The Pharmaceutical market is highly regulated • Manual generation of content is very cumbersome • Maintaining multiple versions of content increases the likelihood of errors or incompliant content • Content repurposing is resource intensive 9
  10. 10. Simplifying the Process with Dynamic Publishing • Automatic Conversion of content into XML-based SPL and PIM • Content can easily be repurposed for usage needs, enabling up-to- date product information • Content retains integrity across all media channels • Decreased label submission cycle time • Information can be easily exchanged with regulating bodies including the FDA and EFPIA 10
  11. 11. Meeting the FDA SPL/PLR & R4 Mandates Michele Cobham Submissions Manager, Regulatory Affairs Par Pharmaceutical 11
  12. 12. Par Became Involved Early On (2005) 1. Teamed up with IS 2. FDA/HL7 SPL Working Group (Generic Team) 3. Requirements Analysis 4. Demos… Evaluations… Comparisons 5. Decision based on Simplicity Costs ‘Getting the job done’ Training Maintenance and Lifecycle Management 12
  13. 13. Par Maintains Compliance with Quark XML Author 2005 2007 2009 Progression Quark XML Author Quark PLR Accelerator Quark SPL Accelerator 2005 – Meets SPL compliance date of 10/31/05 2007 – Meets PLR compliance date of 6/30/07 2009 – Meets the R4 compliance date of 6/1/09 13
  14. 14. XML Solution Benefits to Par’s Business Cost Effectively Maintain FDA Compliance Accelerate the Label Submission Process Improve the Accuracy of Information Reuse Information Across all Publishing Needs 14
  15. 15. Simple and Easy In-House Solution for Par All Labels are Done In-house by Par Staff Cost Effectively Maintaining FDA Compliance Quark Solution is a Simple Solution •MicrosoftWord-compatible plug-in •Cut/Paste exercise Easily Submitted Through the Electronic Submissions Gateway (ESG) •Labeling and Drug Listing submitted simultaneously •Establishment/Registration and NDC Labeler Code submitted yearly ESG Drug Label Drug Listing 15
  16. 16. Improving Accuracy of Information Cut/Paste • Easily re-purpose approved Microsoft Word labeling file • Eliminates typing errors MS Word Template Provides Structure Format Reuse Actual Content of Labeling in Most Drug Listing Information Preview Labeling/drug Listing Content Using the FDA Schema Content of Labeling/Drug Listing Easily Validated Prior to FDA Submission 16
  17. 17. Reusing Information Across all of Par’s Publishing Needs XML Based eCTD Publishing Tool Foresee a Mechanism to Tie in all the Various Parts of an eCTD Submission: • Clinical data from studies Content of Labeling • CMC document Drug Listing and Drug Establishment information • Updates to content of labeling can be submitted with relative ease Prepare for Requirements from Outside Sources for XML Based Labeling such as the PDR 17
  18. 18. Content Management, Translation Management, SPL and PIM: An Implementation of XML across US and Europe Bernie Coney Senior Regulatory Specialist Pfizer 18
  19. 19. Business Drivers Dimension Structured Product Product Information Labeling (FDA) Management Driver Improve Patient Safety through Efficiency in managing large improved information access & volume of labeling content for Medicare Modernization Act (e- industry and regulators (due to Healthcare Record) translations) Approach Due for all new labels beginning Optional for centralized products 10/31/05 (conversion alone due beginning 11/21/05 – still in pilot on Annual Report schedule) phase Format XML with initial monolithic XML with componentized Schema (plan to componentize Schema (only submit/review) the in time) standards set by HL7 paragraph impacted Documents USPI, PPI, Med Guide SmPC, Outer & Inner Labelling Under Focus and Package Leaflet, Annex II 19
  20. 20. Business Goals and Objectives of Content Management System • Compliance: provides an immediate and long-term solution • Operational Efficiency: reduce redundancy in managing labeling content • Quality: generate documents from a single source • Benefits from XML: enables Authors to focus on content rather than format 20
  21. 21. System Architecture Content Translation Management CMS CONNECTOR System System Staging Area • Content Management = Authoring, versioning and rendering of xml into MS-Word documents for US, EU and Core Data Sheets, as well as PIM and SPL (XML) • Translation System = Collaborative translation production system automating the translation through workflow and translation memory • Implementation: Common technology across US and Europe to meet business needs for SPL, PIM, Translation and Authoring 21
  22. 22. Process Efficiency Translation Tool Integration with Content Management System Send English content to translators Classify type of translation request 22
  23. 23. Labeling Consistency MS Word Renditions for US Labeling (also includes SPL) XML Source Clean and Track- Annotations changes versions displayed of content 23
  24. 24. EU Product Information Consistency: Deployment of Translation Memory Similar matches displayed for selection Identifies text to be translated. Displays 100% matches And displays % of match 24
  25. 25. Lessons Learned • Labelling Staff had no experience with XML • Most staff use MS Word daily • XML highly structured • Program Management • Project team deployed multiple tools over time • Cohesion of project team maintained through Core Team • Senior Management support for Program • Change Management • Adoption of new technology • Quality control of XML content (100% manual check initially) • Internal systems not prepared for XML 25
  26. 26. Lessons Learned • Single deployment across regions has been challenging • 3 software tools were used to create system • Managing upgrades to the software • Regression testing • Multiple vendors • Managing Content in XML format benefited staff, enhanced roles and created greater efficiency • 50% reduction in turnaround time for final submission documents in the US 26
  27. 27. Richard Brandt VP of Life Sciences Quark 27
  28. 28. Key Points ● Market Conditions Are Driving Regulatory Change ● New Standards & Technologies Will Offer Relief ● Downstream Benefits Sweeten the Adoption Pot 28
  29. 29. FDA Regulatory Change Where change is the only constant! 29
  30. 30. Why the FDA has adopted XML No Tolerance for Errors “In July 2006, the Institute of Medicine of the National Academy of Sciences estimated that more than 1.5 million people annually are injured due to medication errors.” “The cost of treating hospital-based medication errors alone is conservatively estimated at more than $3.5 billion annually, and this cost does not include estimates for lost wages and lost productivity.” Source: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), June 2008, Electronic Submissions, Revision 1 30
  31. 31. Will the pace of change continue? “Receipt of timely and accurate information will enhance FDA’s efforts to help ensure the integrity of the drug supply and protect public health.”* • Industry maturing with XML standards • Where FDA benefits the path is clear • The only real question is what standards are next… *(Source: U.S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, May 2009, Electronic Submission) 31
  32. 32. Document Management Technology What’s all the fuss about? Benefits of XML in Document Management 32
  33. 33. Open standards offer superior interoperability Quark XML Author for Microsoft® Word U.S. Food and Drug Association Organizations Hospitals Industry Vendors 33
  34. 34. Enhanced indexing improves search ability Quark XML Author for Microsoft Word and EMC Documentum 34
  35. 35. Content re-use streamlines authoring <SPL> 35
  36. 36. Where does SPL go from here? • All label content is now structured. • With a DMS, structured labels can be componentized • Indications can be used in the medical information system • Drug listing can be used in the product packaging • Boxed Warning can be used in magazine ads • Adverse Reactions can be used on the web site • And the list goes on… 36
  37. 37. What is Quark’s and EMC’s role? Drogue Снадобье Drug Web Print Droga Mobile Droge 37
  38. 38. Q&A Mukul Krishna Bernie Coney Global Director, Digital Media Senior Regulatory Specialist Frost & Sullivan Pfizer Michele Cobham Richard Brandt Submissions Manager, Regulatory Affairs VP of Life Sciences Par Pharmaceutical Quark Submit Your Question Below! 38
  39. 39. $500 voucher to any upcoming Executive MindXchange 39
  40. 40. eBroadcast On-Demand Version 40
  41. 41. Giveaway And the winner is… Kindle 41
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