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Whitepaper - Applying Language Technology To Multilingual Labeling
Whitepaper - Applying Language Technology To Multilingual Labeling
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
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.
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. SDLs 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 todays activity levels, improves the consistency and overall quality of the labels and ensures the reuse of standardized terminology to avoid individual mistakes.
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.
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.
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.
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. Todays 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 todays 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.