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PILLS: Patient Information Language Localisation System
Evaluation Workshop
Berlitz GlobalNET - Luton 30 Nov 2001
PILLS is a preparatory action European eContent project, ECD-3310-26904.

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Technical team:
- Information Technology Research Institute (ITRI), University of Brighton UK
- Dr. Donia Scott, Professor of Computational Linguistics, Director of ITRI
- Dr. Richard Power, Reader in Computational Linguistics
- Medical Informatics Institute, University of Freiburg, Germany
- Dr. Stefan Schulz, MD, PhD in Public Health

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Market research team:
- Berlitz GlobalNET Ireland
- Rose Lockwood, Director of Research
- Berlitz GlobalNET UK
- Dawn Murphy – Consultant

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Objectives for the day
- What we want to do
- Explain the rationale for the project
- Explain how  the PILLS system works
- Show you the system working, and let you use it
- Get your advice and feedback on whether and how we undertake further development of the system
- What we want you to do
- Advise us on whether we have correctly understood the publishing requirements and challenges in the pharma industry
- Give feedback on regulation and localisation issues
- Experience PILLS for yourself
- Give feedback (and evaluation) on functionality, applicability of PILLS
- Collectively explore ideas for further development

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Agenda
- The pharmaceutical business environment
- Challenges for pharmaceutical publishing
- Regulation, harmonisation and localisation
- The PILLS solution
- Demonstration and test drive
- Evaluation

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Pharma industry trends and challenges
-  Consolidation
quest for market share in highly competitive market
product line integration, premium on comprehensive solutions, efficiencies in distribution and service
-  Globalisation
driven by changing policies (free trade), regulatory shifts (harmonisation)
leveraging sales & marketing for larger customers, exploiting global opportunities
-  Impact of technology
shorter product cycles, faster time-to-market
- Internet effect: new purchaser buying-power, shifts in the value chain  (new intermediaries), new market segmentations

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Changes driven by the Internet
- Supply-chain relationships
- Use of intranets for electronic exchange of research, compliance and product info
- Integration with manufacturer, packaging supplier, sub-tier supplier systems
- Customer relationships
- Direct, transparent markets
- Pressure on cost and turnaround
- High visibility
- Relationships with doctors, pharmacists, patients
- Direct-to-consumer trends
- “e-Detailing”

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New channels to regional and global markets
- Fast growth in hospital e-procurement take-up in the US
currently $6.3 billion market
grew by over $1.6 billion in 2000
- Integration of European procurement market
e.g. NHS Supplies (UK) linking with other European providers to benchmark prices across Europe
likely to catch up with the US as Web infrastructure solidifies
- Localisation becomes competitively significant in cross-border markets
- Flexible publishing solutions needed

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Impact of these trends on pharma publishing
- Technical publishing issues
information design, Web architecture, multiple publishing formats
- Information ecology - leveraging content for multiple publishing requirements, e.g.
marketing, labeling, instructions for use, operator manuals
brochures, leaflets, manuals, support documentation (Print, CD, Web)
- Language and culture
translation, adaptation to local conditions, symbology
- Legal & regulatory
local and regional conformance
- Industry-specific trends
good practice, standards

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New levels of market exposure through Web publishing
- Globally available product showcases
- In regional and global markets
- With diverse cultural and social norms, business cultures
- Increasing communication across language barriers
- Increasingly localised, with
- Content highly adapted to local conditions
- Combining local content with global product information
- With a mix of document and format types, stylistic forms and registers, variations in presentation of the same or similar content.

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The context for regulatory change
- ICH
- Changing European regulatory regime:
- EMEA, EDQM
- Mutual Recognition Procedure
- Pharmacopoeia
-    ...with similar content also published in less regulated environments such as Web portals
- Dramatic impact on use and re-use of pharma product info...

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Pharma localisation challenges
- 13 EU languages – legal requirement for central authorisations
- New countries joining EU (8 new languages anticipated in the near term)
- 20 days to produce translations
- 1000s of documents
- Updates may be several times a year
- Version control challenge
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Source : PILLS