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Reducing Regulatory Approval Time Via Smart Use of Language and Effective Registration Tracking
Connie Dominguez 2min read 07/05/18
It’s hardly exaggerating to say that the consequences for mistranslation of labeling and packaging in life sciences are potentially catastrophic. Most importantly, there is a substantial risk of patient safety that could occur, where, for example, misinterpretations in dosing could mean a matter of life or death.
For any drug manufacturer, the resulting fall-out from that would be almost impossible to recover. Even if it could manage the global PR disaster that would arise, the chances of getting in hot water with the health authorities are high, meaning that firm’s ability to market and sell its products would be severely impacted.
So accurate and effective translation is a big deal and one that manufacturers simply must get right. But it’s also a major challenge. Life sciences is a global market, with some products sold in hundreds of countries across the world, requiring large-scale translation services into multiple languages. We estimate that when you consider the total labeling content a pharmaceutical company may collectively manage over the course of a year; the number is in the tens of millions of words. This is a significant amount of content to manage – and to make sure it’s error-free.
How can life sciences firms navigate the complexity of labeling and packaging translations, ensuring accuracy but not being overly-costly?
When considering translations of labeling and packaging in life sciences, the most essential and overarching factor is always patient safety. Patient safety should never be comprised, nor confusion about the right approach and materials must be 100% accurate.
The consequences of getting this wrong are severe, so above all else, translations must be accurate, and they must always keep patients safe.
Traditionally, translation services in life sciences have very much followed a localized, or decentralized approach. This involves using local, in-country partners to manage labeling and packaging translations into that particular language. The idea behind this is that it will be less costly and the local partner will, in theory, have a better handle on regulations in their market.
However, this approach can lead in some cases to an impact on safety, due to errors in labeling. While the manufacturer does its best to maintain quality control and should always do its proper due diligence, sometimes errors can slip through the net using a localized approach. It’s critical for manufacturers to consider a global audience at the time of authoring their English content.
That’s why the past few years has seen the emergence of a trend towards a more centralized strategy for managing translation. Larger language services firms such as AMPLEXOR not only have the expertise and market understanding to ensure safety and accuracy, but they also have the technology to make centralized translations a more cost-effective option.
As a languages student, I started my career in translation before moving into the life sciences sector, so it is always interesting to me to hear how different people approach translations. There are some common mistakes that crop up time and again – here are two of the main ones to be aware:
AMPLEXOR has the expertise and experience to manage all translation services that you might require, honed from decades working with some of the biggest names in the pharmaceutical and life sciences sectors. Our first-hand experience working on global translations for packaging and labeling means we understand the importance of accuracy and safety and can balance that with smart and capable approaches and solutions.
Further information on AMPLEXOR’s Language Services for Life Sciences can be found here.
Kathleen O’Brien is Director of Business Development with AMPLEXOR Life Sciences and a 15-year veteran of the translation industry. Kathleen has a background in linguistics and has held various roles in the translation business: vendor, project and account management, as well as new business development, giving her a unique perspective into both translation operations and how translation impacts the globalization needs of her clients in the pharmaceutical and medical device industries. She proactively collaborates with her life sciences client partners on a daily basis to help them set their localization strategies.
Connie Dominguez 2min read 07/05/18