The SDL Pharma Labeling Solution Meets the
Unique Needs for Multilingual Labeling
Background and Scope
Pharmaceutical drug development 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 with the late clinical phase, information is required in multiple languages as it is shared beyond
the source lab or home office. SDL has multiple solutions that make the pharmaceutical translation process more
efficient, less costly and easily auditable by any regulatory agency. In fact, SDL has developed a solution specifically
to support the pharma global labeling process. This whitepaper introduces the new global labeling solution that
combines leading translation management technologies with services specialized to support the pharmaceutical
industry. With this total solution, the central global labeling group and local-language affiliate organizations are
enabled to optimize all the translation steps required to support the drug labeling process.
Contents
Regulatory framework........................................................................................................................................................... 2
Label changes (on top of label changes).................................................................................................................. 2
The unique pharmaceutical labeling challenge................................................................................................... 2
SDL Pharma Labeling Solution
A translation management system purpose built to support
the multilingual labeling process.......................................................................................................................... 3
The mandated way of handling tracked changes and comments........................................................... 3
Translation memory (TM).................................................................................................................................................... 5
Terminology management................................................................................................................................................ 5
SDL WorldServer enables centralized control of the translation process............................................. 5
Other features of the SDL Pharma Label translation.......................................................................................... 6
Process setup and workflow definition pays dividends for every labeling project........................ 7
Summary....................................................................................................................................................................................... 8
Language
White Paper | SDL Pharma Labeling Solution
Regulatory framework
Pharmaceutical companies deal with stringent regulations
whenever they submit product information (PI) into
a world-wide product registration process. This is a
critical process, as it determines how well decades of
discovery and clinical investments will be understood and
adopted by stakeholders including patients, health care
professionals and payers. Submitting product information,
and doing it accurately the first time, directly impacts
corporate revenues, company reputation and future
medical advances.
2
The unique pharmaceutical
labeling challenge
The process to create a new drug is extremely complex.
While a translation management system will benefit many
parts of the process, this white paper will focus exclusively
on the complexities of drug labeling. There are several
important requirements for language translation in the
labeling process:
•
During the label change process, regulators
require that the science team mark all requested
amendments in the original submission using
Microsoft Word’s “Track Changes” and “Comments”
feature.
•
The applicant then must prove that all changes in the
source documents have been adequately reflected in
each of the targeted languages, again using Microsoft
Word “Track Changes” and “Comments.
•
The regulations further stipulate that there be proof
that no other portions of the text have been altered in
any way.
Label changes (on top of label changes)
Formal regulations, which vary by geography, stipulate
how PI has to pass regulatory review. In the EU, PI
validation must be done in 24 languages. Moreover,
global pharmaceutical companies are required to
conduct business in 50+ languages, with data requiring
constant updates and regional coordination. Currently,
there are a limited number of new chemical or biological
substances which are entering the market as initial
submissions. However, advances in medical practice
and pharmacovigilance are driving the requirements
for continual updates of PI across the globe. In practice,
this means that every drug manufacturer with an active
portfolio is facing thousands of yearly updates to required
translation projects with very tight timelines, hundreds
of stakeholders and strict procedures in order to gain
regulatory approvals.
Managing changes in this mandated way creates
technical challenges for labeling managers beyond
just language translation. Most automated translation
solutions today work on the entire body of the text and do
not support the processing of tracked changes in the way
outlined by governmental regulations. Generally available
translation tools have not been designed to support these
specialized requirements. Additionally, current systems are
not concerned with recording, preserving and displaying
an audit trail of the changes in the final output. In most
non-regulated instances, users are only concerned with
seeing the final translated document as it will be seen by
the end user. However, when regulators review translated
PI they also want to see the final translated content with
tracked changes.
Why does this have far-reaching
consequences?
•
Since conventional translation management tools
do not support this unique requirement, a parallel
manual process must exist in the pharma industry to
preserve the history of the changes. All changes have
to be painstakingly and very accurately re-introduced
into the final delivery documents. This is tedious
manual work requiring costly overhead, particularly in
the tight time spans required by regulations.
White Paper | SDL Pharma Labeling Solution
•
After re-submission to the regulatory bodies, the
reviewer again uses the “Track Changes” tool to make
further comments. As a result of the tight timeframes
of the process, these changes rarely find their way
back into the automated processes of conventional
translation tools. This negatively affects future label
update submissions as the new changes will not
benefit from previous updates.
•
Not being able to use a specialized translation
management tool forces manual re-formatting of the
final document when translating directly in Microsoft
Word. In addition, the inability to review source and
translated documents side by side makes analyzing
translation changes difficult.
•
The requirement to maintain non-changed content
exactly as in the original demands the ability to
lock segments of the content. This is a feature not
generally found in translation management systems.
Under the short timelines demanded for the labeling
change process, highly paid medical professionals are
often pulled into manual translation tasks instead of
managing tasks for which they were hired. A specialized
language translation management system can
significantly lower the multilingual work load, improve the
quality of the final product, decrease associated costs and
free valuable staff member time in managing the labeling
process.
While most industries today enjoy lower cost and
higher translation efficiencies from using a translation
management system, the specialized requirements of
the pharmaceutical industry means that unless they use
a system specifically built to support them, they cannot
gain those benefits for their labeling process. Most of
today’s translation management systems cannot handle
Word-based labeling and review procedures.
3
SDL Pharma Labeling
Solution
A translation management system built to
support the multilingual labeling process
SDL has designed and built a translation management
system to optimize the pharma labeling process. 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, including fast label changes
and quick creation of consistent, high-quality global
product information. SDL WorldServer, the industry
leading translation management system, now has these
capabilities. When SDL WorldServer is combined with
SDL Trados Studio translation editing tools and services
experienced with working with the pharma industry,
this creates a comprehensive, industry-unique labeling
solution.
The mandated way of handling Tracked
Changes and Comments
SDL’s Pharma Labeling Solution changes the way labeling
information is processed. SDL has taken the necessary
steps to enable its offering to address the very specific
requirements of handling labeling documents. These
include:
Handling Tracked Changes during translation
The translation editing process is enabled to efficiently
handle tracked changes and regulator comments in
the source and target languages. Various use cases are
associated with this capability. These include, but are not
limited to:
1. Using documents that have been amended using
Tracked Changes
2. Improved internal review using Tracked 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. Toggling Tracked Changes across source and target
segments to see different versions (original, final, final
with markup)
SDL Trados Studio is a translation editing tool that makes
local language translators more efficient and effective.
With a direct connection to SDL WorldServer, documents
requiring translation are distributed to target translators.
Given the short times frames required by regulations,
optimized translation communication is required.
White Paper | SDL Pharma Labeling Solution
4
The following screenshot from the translation editor in SDL Trados Studio demonstrates how changes are tracked and
preserved between the source and target language documents.
Figure 1:
Translation of amended PI
Protecting unchanged text during PI updates
The SDL Pharma Labeling Solution will automatically lock down parts of the text to avoid unwanted changes. This increases
the turn-around time for label changes, as it eliminates unnecessary translation or review work not in scope of the required
label change.
In the Figure below, the darkened text is visible to the translator to provide translation context, but they are unable to
make any changes.
Figure 2:
Lock down of text not requiring
translation
White Paper | SDL Pharma Labeling Solution
In addition to the ability to use Microsoft Word
documents, SDL WorldServer has two key components
that greatly improve translation quality and efficiency.
They are:
Translation memory (TM)
Translation memory (TM) allows a translator to boost
productivity while at the same time make translations
more consistent. Technically, TM is a translation editor with
a database which systematically stores all final regulator
approved translations. Translators then use this database
to identify content for which there are already approved
translations. The TM will also identify new content and
retrieve similar or “fuzzy” translations that translators
can use to speed up their process. The benefits of a
well-functioning TM include a reduction in the cost for
translations as content is not needlessly retranslated, and
more consistent translations over time.
5
SDL WorldServer enables centralized
control of the translation process
SDL WorldServer allows pharmaceutical teams in
headquarters and affiliate functions to automate many of
the manual work steps and manage the entire translation
process programmatically. A single instance of SDL
WorldServer ensures that all previous translation work
and regulatory reviews are applied consistently to all new
translation work. It enforces a consistent use and control
of core corporate and drug terminology.
There are many benefits to the labeling process of using
a single translation system beyond the ability to create
documents in Word, as described previously:
•
Each individual request for a label change creates a
complex set of tasks across the multiple languages
targeted. If done manually, translation managers
would have to communicate individually with
dozens of translators and reviewers. SDL WorldServer
automates this entire process and can reduce
the number of human steps to as few as four per
document.
•
In addition to automation of manual work steps, a
translation management system tracks where each
document is in the translation process. At a glance,
the project manager can see if the translation
requests have been received, if the work is in process
and what percentage of the documents have final
translations available.
•
If a new language is added to the required target list,
or a new document type requires a unique translation
process, these can be added centrally and easily and
then have automatic implementation for all future
reviews.
•
SDL WorldServer can track the costs of document
translation services if these are required for individual
product line P&Ls.
Terminology management
Terminology management is an organized record of
controlled words and phrases combined with their
standard or mandated translations. This database
allows you to manage commonly used words as well as
slogans or corporate phrases that must be translated in a
particular way (for example, a company tag line, product
or feature name). This eliminates subtle translation
changes being introduced and maintains the quality
and consistency of local language content with that
of the source material. This is particularly important in
the pharma industry, as drug terms have very precise
meanings and these need to be preserved through the
translation process.
White Paper | SDL Pharma Labeling Solution
6
Other features of the SDL Pharma Label translation
SDL’s new and unique approach unlocks the translation
reuse mechanisms and the typical benefits from
translation technology for labeling. Translation Memory
and Terminology Management 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
Involving the experts in the review
Handling complex products with multiple
strength and presentations
The new SDL solution for global labeling simplifies the
review of translated documents by both internal and
external experts. The SDL solution can automatically
create a Microsoft Word document which allows the
reviewer to assess whether the requested changes are
adequately reflected in the translations. The document
clearly highlights the relevant text parts and allows the
reviewer to use Tracked Changes and comments during
the review step. All changes from the reviewer are then
captured back in SDL WorldServer as a base for future
amendments.
Figure 3:
Auto-propagate identical text parts
Regulations require very specific “boiler-plate” translations,
including headers or other standard textual portions of
the document. During new document creation, these
formats can automatically be inserted and then be locked
against accidental changes.
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 more complex the product, the more redundant
text parts have to be handled during new marketing
authorization procedures. Using the SDL Pharma Labeling
Solution, the translation editor ensures that identical text
parts are automatically propagated across the documents.
This mechanism of auto-propagation allows for highly
consistent PI. The following screenshot demonstrates this
mechanism.
White Paper | SDL Pharma Labeling Solution
7
Process setup and workflow definition pays dividends
for every labeling project
Critical to the successful deployment of the SDL Pharma
Labeling Solution is working with the enterprise experts
to customize the workflows prior to deployment. SDL
Language Solutions experts have studied and deployed
literally hundreds of translation processes in industries of
all kinds. They understand common translation pitfalls and
are experts on the SDL technologies that compose the
solution. Language Solutions experts will cover:
•
Linguistic Source Analysis – Translation experts will
examine the existing labeling content and identify
potential problems. They will review and analyze
existing translation materials and clarify any linguistic
questions. Jointly with the Pharma experts, translation
best practice guidelines will be developed to ensure
compliance with latest global regulations.
•
Linguistic Alignment & Strategy – SDL experts
will work to create a single, high-quality translation
database and a single terminology manager
populated with all mandated phrases, terms and
approved labeling translations. Then they will define
a translation strategy to meet the business and
regulatory requirements for the sponsor.
•
Process & Training – Using the strategy, the workflow
features of SDL WorldServer will be customized to
enforce the correct labeling document flow, from
the central team, to affiliates, translators and the
regulators. As part of this process, SDL will train and
educate the stakeholders on the linguistic tools to
support current and future labeling requirements.
Following these initial steps will ensure a “fix once and for
all” principle that will benefit every subsequent translation
project.
White Paper | SDL Pharma Labeling Solution
8
Summary
The SDL Pharma Labeling Solution has been developed to
enable the automation of the unique process required by
pharmaceutical regulators. This solution can significantly
reduce the efforts in labeling translations, improve quality
and significantly lower the amount of administrative
overhead typical of other translation tools.
The majority of today’s translation management systems
cannot handle the mandate of Microsft Word-based
labeling procedures. SDL has met this challenge by
enabling a Word-based translation process. There are four
major benefits of the SDL innovation. The SDL Pharma
Labeling Solution allows companies to:
1. Meet the aggressive mandated PI translation time
windows by efficiently managing the frequent label
changes during product maintenance in the linguistic
phases.
2. Automate the translation process and unburden all
stakeholders from many of the manual tasks such as
formatting, tracking and routing work requests.
3. Lower translation workloads through the use of
translation memory and terminology management so
that pharma companies are paying for translations of
only new content.
4. Improve the quality of the final labeling content by
simplifying the review and linguistic quality assurance
process
With special focus on the initial set up of the SDL solution,
these benefits can accrue automatically to all subsequent
projects. These benefits shorten the translation process
so labeling changes can occur within the tight windows
mandated by regulators.
Through this total solution of enhanced products
and pharma-specific setup and training, SDL provides
pharma companies with quantifiable benefits of faster
performance, reduced administrative burdens and higher
quality labeling output.
SDL (LSE: SDL) allows companies to optimize their customers’ experience across the entire
buyer journey. Through its web content management, analytics, social intelligence, campaign
management and translation services, SDL helps organizations leverage data-driven insights to
understand what their customers want, orchestrate relevant content and communications, and
deliver engaging and contextual experiences across languages, cultures, channels and devices.
For more information, visit www.sdl.com
SDL has over 1,500 enterprise customers, over 400 partners and a global infrastructure of 70
offices in 38 countries. We also work with 72 of the top 100 global brands.
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