Slides from a webinar hosted by Frost & Sullivan and sponsored by Quark on XML in pharma. I did not create these but there is no copyright indicated on the materials -- if you object to the uploading of these, please contact me.

1. The FDA Mandates XML
Maximize Your Investments
through Dynamic Publishing
Thursday, November 5, 2009
11:00 AM ET / 8:00 AM PT
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2. Welcome and Housekeeping
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eBroadcast On-Demand
A recording of this eBroadcast will be available at
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Giveaways
All registrants will receive a $500 voucher toward any one of our upcoming
Executive MindXchange events.
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3. Giveaway
Kindle
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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
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5. Mukul Krishna
Global Director, Digital Media
Frost & Sullivan
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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
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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
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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.
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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
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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
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11. Meeting the FDA SPL/PLR & R4 Mandates
Michele Cobham
Submissions Manager, Regulatory Affairs
Par Pharmaceutical
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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
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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
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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
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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
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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
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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
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18. Content Management, Translation Management, SPL and PIM:
An Implementation of XML across US and Europe
Bernie Coney
Senior Regulatory Specialist
Pfizer
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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
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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
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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
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22. Process Efficiency
Translation Tool Integration with Content Management System
Send English content to
translators
Classify type of translation
request
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23. Labeling Consistency
MS Word Renditions for US Labeling (also includes SPL)
XML Source
Clean and Track- Annotations
changes versions displayed
of content
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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
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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
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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
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27. Richard Brandt
VP of Life Sciences
Quark
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28. Key Points
● Market Conditions Are Driving Regulatory Change
● New Standards & Technologies Will Offer Relief
● Downstream Benefits Sweeten the Adoption Pot
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29. FDA Regulatory Change
Where change is the only constant!
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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
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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)
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32. Document Management Technology
What’s all the fuss about?
Benefits of XML in Document Management
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33. Open standards offer superior interoperability
Quark XML Author
for Microsoft® Word
U.S. Food and Drug Association Organizations Hospitals Industry Vendors
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34. Enhanced indexing improves search ability
Quark XML Author for Microsoft Word and EMC Documentum
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35. Content re-use streamlines authoring
<SPL>
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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…
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37. What is Quark’s and EMC’s role?
Drogue
Снадобье
Drug
Web
Print
Droga
Mobile
Droge
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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. $500 voucher to
any upcoming
Executive MindXchange
www.frost.com/cal
39

40. eBroadcast On-Demand Version
www.ebroadcast.frost.com/dynamicpublishing
40

41. Giveaway
And the winner is…
Kindle
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