White Paper
Applying Language Technology to Multilingual Labeling
Written By: Matthias Heyn VP Global Solutions, SDL June 2012 
Applying Language Technology to Multilingual Labeling Background and Scope Pharmaceutical business processes are typically divided into several phases: discovery, clinical, registration (regulatory), production, safety, sales and marketing. Together, they reflect the overall pharmaceutical product life cycle. Starting from late clinical, these phases are sensitive to multilingual information processing and SDL has various solutions available to make such processes more efficient. This whitepaper introduces a new global labeling solution that combines the leading translation management technology with the most widely adopted translator desktop tool. With this combined solution designed for the pharmaceutical industry, central global labeling groups, as well as involved local affiliate organizations, are enabled to improve the overall process when it comes to maintaining marketing approvals from local regulators for all major procedures involving translations.
Table Of Contents Regulatory Framework.......................................................................................................................3 Label changes (on top of label changes)..........................................................................................3 Why is there no technical solution today?.......................................................................................... 3 Translation Memory (TM)............................................................................................................... 3 Translation Management Systems (TMS).......................................................................................3 Technical road blocks in the labeling context.................................................................................4 The SDL solution for global multilingual labeling...............................................................................5 Supporting the regulatory way of handling tracked changes and comments................................5 Unleashing the power of translation technology for labeling.........................................................7 Summary..........................................................................................................................................8
2
Regulatory Framework Pharmaceutical companies deal with regulator imposed overhead whenever they submit product information (PI) into world-wide product registration procedures. This is a critical deciding milestone, as it determines how well decades of discovery and clinical investments will be understood and adopted by patients, health care professionals and payers. It impacts revenues, company reputation and further medical advances and is core to all involved companies.
Label changes (on top of label changes) Formal rules, in force world-wide, stipulate how PI has to pass regulatory review. In the EU, this currently concerns PI validation in 24, and soon in 25 languages. However, big pharma companies are facing 50+ language versions while submitting globally for registrations so PI has to be constantly updated and kept in sync. Given the current pipeline drought in pharma, there is a limited number of new active ingredients (new chemical or biological substances) which enter the markets as initial submissions on a yearly basis. However, advances in medical practice and pharmacovigilence (among other factors) drive constant updates of PI across the globe. In practice, this means that every drug manufacturer with a sufficiently active portfolio is facing thousands of yearly updates to PI following very tight timelines, involving hundreds of stakeholders, adhering painstakingly to strict procedures while filing updates for approval.
Why is there no technical solution today? Labeling is a classic and prime candidate for language technology solutions to ease the burden described above. The two key components of the solution are translation memory (TM) and translation management (TMS) technologies.
Translation Memory (TM) A translation memory (TM) allows a translator to boost productivity while at the same time making translations more consistent. Technically, this is a translation editor which integrates a database (the TM) which systematically stores all final regulator approved translations. Translators then use this database to translate product updates or related product information, retrieving immediately similar or identical previously approved translations. A TM is accessed in the translation editor which allows for additional productivity enhancements, specifically when it comes to handling labeling content. This will be addressed with more details later in this document. An example of a TM solution is SDL Trados Studio.
Translation Management Systems (TMS) In addition to utilizing a centralized, server-based Translation Memory—with all the benefits mentioned above—a translation management system (TMS) allows pharmaceutical teams in headquarter and affiliate functions to initiate, supervise, coordinate and control the overall translation process with all internal or external stakeholders, while systematically leveraging approved translations from a TM and by automating many of the manual work steps. It also enables consistent use and control of core terminology as they relate to the specific product information. An example of a TMS solution is SDL WorldServer.
3
There are various reasons why labeling content lends itself to be managed through a TMS: •
As laid out in the introduction, PI undergoes constant changes (label changes) which often require the coordination of thousands of work steps across several groups (central labeling, affiliate expert reviewers, external translation service providers) in order to feed into regulation by local or regional health authorities (regulators). A TMS can substantially ease such coordination efforts.
•
In addition to automation of manual work steps, a TMS provides traceability, to make it easy to identify the status of a translation during the submission process. This in turn, provides a consistent workflow that can scale to a business’ needs.
•
For almost all regions, the format in which regulators expect these documents is Microsoft Word, which remains the dominant format at least for the next decade. SDL’s TM and TMS file type support for MS Word eliminates the tedious manual formatting efforts when it comes to implementing the EU QRD template guidelines.
•
PI is a highly repetitive and redundant text type. Use of a translation memory brings down the workload to a fraction of today’s activity levels, improves the consistency and overall quality of the labels and ensures the reuse of standardized terminology to avoid individual mistakes.
Technical road blocks in the labeling context There are a few important caveats to consider when looking at applying TM and TMS technology to labeling: •
During the frequent label changes, the regulator requires that the science team mark all requested amendments in the current legally binding submission using the Microsoft Word “Track Changes” and “Comments” features.
•
The applicant then must demonstrate and prove that all changes in the source documents have been adequately reflected in all target languages, again using Microsoft Word “Track Changes” and “Comments.”
•
Reviewers and translators understand that they should not touch any other text parts, but only focus on the tracked changes and comments in any update.
Maintaining changes in this way creates technical challenges for IT tools and processes. Most TMS solutions today work on the body text and do not support the processing of tracked changes in both the source and the target language. They have not been designed so they can differentiate between the proposed changes and the proposed translations for such changes. Additionally, current systems are not concerned with displaying the tracked changes life cycle in the final output. In most non-regulated instances, users are only concerned with seeing the final translated document as it will be used. However, when regulators must review translated PI they also want to see the proposed translations with tracked changes so Pharmaceutical companies need to deliver a final translated document containing original and proposed changes to the regulator. Historically, this review step has been outside of the normal translation process, as conventional TM changes are not maintained after translation. Why does this have far reaching consequences? •
It offsets the value of the TM, as all tracked changes have to be painstakingly and very accurately reintroduced into the final delivery documents. This is tedious manual work and unwelcome overhead in the tight regulatory time span.
•
After resubmission, the regulator again uses Tracked Changes to make further comments. Under current timelines, these changes rarely find their way back into the translation memory, which offsets the value for future update submissions.
4
•
Not being able to use a TM solution forces manual re-formatting work while translating directly in Microsoft Word.
•
The inability to review documents in a bilingual representation makes analyzing translation changes more difficult. Translation memories, in contrast, make it very easy for reviewers to compare source and target languages.
•
Not being able to lock segments of the content that correspond to the approved, legally binding translations from previous submissions is a constant battle for all labeling stakeholders.
•
Not being able to efficiently use a TM in turn offsets the value of a translation management system and associated workflows as well.
While most industries today enjoy lower cost and higher process efficiencies when deploying a TMS system, the pharmaceutical industry has not been able to capture such values for labeling. Labeling is an area where professionals are often pulled into translation related activities instead of the content related activities for which they were hired. A TMS can offset this, as it has the capacity to significantly lower multilingual work load, decrease associated costs, and free valuable staff member time spent managing translation so they can focus on higher value content creation activities. While the previous information has focused on challenges for pharmaceutical companies, translation service providers are also impacted, as they are unable to provide the efficiencies which are common practice for any other type of text. A new solution for labeling translations that addresses these challenges can have widespread impact on both companies and their vendors.
The SDL solution for global multilingual labeling Supporting the regulatory way of handling tracked changes and comments The new SDL Solution for global multilingual labeling changes the way labeling information can be processed. SDL has taken the necessary steps to enable its language technology offering to address the very specific requirements of handling labeling documents. Handling tracked changes during translation First and foremost, the translation editing process and the embedded TM are now enabled to efficiently handle tracked changes and regulator comments in the source and in the target language. This enables the actual usage of the TM for label changes across languages. Various use cases are associated with this capability. These include, but are not limited to: 1. Using a TM with documents that have been amended using tracked changes 2. Improved internal review using Track Changes 3. Improved regulator review of the target language file with and without tracked changes 4. Preparation of file bundles going into regulator review (including the Microsoft Word document with and without tracked changes) 5. Making tracked changes for both source and target segments visible, or alternatively hiding them, to see the different versions (original, final, final with markup) The following screenshot from the translation editor in SDL Trados Studio demonstrates some of the innovative 5
capabilities to handle regulatory amendments.
Figure 1 – Translation of amended PI
Involving the experts in the review The new SDL solution for global labeling simplifies the review step of the adapted translations for the internal or external expert. The SDL solution can automatically create a Microsoft Word document which enables the reviewer to assess whether the requested changes are adequately reflected in the translations. This representation clearly highlights the relevant text parts and facilitates the use of tracked changes and comments during the review step. All changes from the reviewer are then captured back in the TM as a base for future amendment of this text.
Figure 2 – Involving the reviewer
6
Unleashing the power of translation technology for labeling SDL’s new and unique approach unlocks the translation reuse mechanisms and the typical benefits from translation technology for labeling. TM and TMS become applicable for labeling documents and can help lower the burden and cost in handling global product registrations. In the following, a few additional benefits are presented. Handling standard headers and standard text The regulators are imposing very specific “boiler-plate” translations for headers or other standard textual passages. At point of printing this whitepaper these are, e.g., the EU QRD Template versions 8.1. During new marketing authorizations, such translations can automatically be inserted through a specialized translation memory and then be locked against accidental changes. Handling complex products with multiple strength and presentations Complex pharmaceutical products are often brought to market in a wide range of strengths (e.g., 100ml or 150ml) or presentations (e.g., as a tablet, vial or cartridge). The higher the complexity of the product, the more redundant text parts have to be handled during new marketing authorization procedures. In these cases, the translation editor ensures that identical text parts are automatically “propagated” throughout the document. This mechanism of “auto-propagation” allows for highly consistent PI. The following screenshot demonstrates this mechanism.
Figure 3 – Auto-propagate identical text parts
Protecting unchanged text during PI updates Finally, the new SDL Solution for Global Multilingual Labeling makes automatically locking down parts of the text possible during variation filings to avoid unwanted changes. This increases the turn-around time for label changes as it effectively eliminates unnecessary work, translation and review of text which is not in scope of the label change in the current variation. 7
Summary A translation management system (TMS) such as SDL WorldServer with its embedded translation memory (TM) and a translation Editor like SDL Trados Studio are key solutions to address the communication and coordination overhead to maintain global pharmaceutical product information. A TM can significantly reduce the efforts in labeling translations and raise consistencies. A TMS can significantly lower the overwhelming communication overhead experienced as part of the global labeling process. Today’s translation memory systems cannot handle Word-based labeling review procedures which offsets the many possible benefits of using a TMS for pharmaceutical product submission procedures. SDL has radically changed this situation for today’s Microsoft Word based regulatory approval processes. Through the introduction of handling tracked changes throughout the translation and translation review process, a TMS now can be applied and many of the possible process improvements have been unlocked. There are 5 major benefits of this innovation. The SDL solution for global multilingual labeling allows companies to: 1. Efficiently manage the frequent label changes during product maintenance in the linguistic phases 2. Unburden all stakeholders from manual formatting work (e.g., following the complex and demanding EU QRD guidelines for Microsoft Word) 3. Lower translation workload through the translation memory and other translation productivity functionalities such as auto-propagate enforcing consistency 4. Simplify the review and linguistic quality assurance process 5. Eliminate communication overhead By enabling this new solution to handle Microsoft Word documents with source and target language tracked changes, SDL now offers highly tangible benefits to pharmaceutical companies, both large and small, for fast turn-around label changes and fast creation of consistent high quality global product information.