Medical Translation Insight

Anabel Pérez is one of our Senior Project Managers here at ForeignExchange Translations. She has been involved in the medical localization field since 2004 in a variety of roles from freelance translator to in-house proofreader and localization project manager.

Over this period, Anabel has gathered a lot of know-how around EMA submissions. She understands that translating product information documents in preparation for an EMA submission can be a frustrating, complex, and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.

In her presentation Meeting the Linguistic Requirements for EMA Submissions, looks at the the pain points encountered when translating for an EMA submission and proposes solutions, innovations, and best practices that will allow client and medical translation supplier to work together collaboratively to meet all the EMA requirements.

Anabel's presentation covers:

• Project start-up – start right to finish well (communication protocol, scheduling, linguistic strategy)
• QRD requirements (linguistic and formatting)
• Tools for QA (QRDetect™)
• Pain points: affiliate & member state review, timetables, change management
• Post-mortem process: learning and improving

Register or download the recording to learn how to take the linguistic pain out of EMA submissions!

For related information, take a look at the following:

• Complying with EMA's New Mandatory Requirements for Medicinal Product Information (EVMPD)
• QRD templates are imperfect, getting better
• QRD compliance just got easier thanks to QRDetect
• Requirements for readability testing of PILs

ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.
 

The Saudi Food & Drug Authority (SFDA) is still relatively young - it was only established in 2003. That doesn't stop the agency from embracing eCTD though.

SFDA published some information regarding their roadmap towards electronic submission. The timeline looks like this:

• Starting from December 20, 2011, NeeS submissions for human medicinal product dossiers will be accepted by the SFDA according to the Guidance for Submission [PDF link] which has been released in version 3 in December 2011.
• As of September 01, 2012, the NeeS format will be the mandatory submission format for the SFDA. No other formats will be accepted.
• Starting on January 05, 2013, the eCTD will be accepted, which will become the preferred submission format one year later (starting on January 04, 2014).
• Finally, starting from January 03, 2015, only eCTD will be accepted.

The above information is adapted from Exalon and SFDA's web site.

You might also be interested in the following articles:

• What happened to the "global" eCTD?
• eCTD translation
• Working with numbers in Arabic translations

ForeignExchange Translations provides specialized translation services for regulatory submissions by pharmaceutical and medical device companies. Contact us to learn more.
 

2012 has started and medical translation clients and professionals are slowly returning to work after taking time off over the Holidays. This is a good time to review the most popular audio conferences and webinars from the past year.

Our team produced roughly 120 events - 2 to 3 every week of the year - that attracted close to 5,000 attendees. Many of our events were in the areas of clinical research, quality management, regulatory affairs, and, of course, translation.

This diversity is also reflected in our list of the five best sellers for 2011:

1. Sample Size for Design Verification and Validation
2. Off-label Promotion – What FDA Looks For & What You Need to Know
3. Best Practices for Writing Safety Narratives
4. Advanced Human Factors Engineering
5. eLabeling Medical Devices for the EU Market

If you have a suggestion for a topic you would to present, be sure to send us a note!


For a detailed proposal on your next clinical, regulatory, or marketing medical translation assignment, contact ForeignExchange Translations.
 

What is Dunglish, you ask?

A) The combination of the words Dutch and English.

B) The language produced when these two languages collide.

C) A blog by Natasha Cloutier.

Sure, the web is full of Chinglish examples but there is just something uniquely funny about the language produced by Dutch speakers who have been abroad too long, and by English speakers whose English is going Dutch.

Maybe it's because one assumes that they should know better? Chinese, after all, is a totally different language, and most of its speakers don't grow up with English.

Not so in Holland though. Or at least that's the stereotype. Doesn't everybody in Holland speak perfect English?

With the help of Dunglish (as well as this less-than-perfect English web site for a Dutch language school), it's becoming clearer that, like most stereotypes, this one may be just a wee bit off the mark...

After you've subscribed to Dunglish, take a look at more funnies at Übersetzungsfehler and Mox's Blog.


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A belated Happy New Year to all of our readers!

2011 was a terrific year for Medical Translation Insight. We were able to report on important issues impacting medical device and pharmaceutical companies, suppliers, and translators. As a result, our readership has more than doubled. We appreciate everybody's interest and support!

December was a good example of our efforts. We were able to generate good discussions on a number of topics. Here are the most-read articles from the past month:

1. Readability is important (and difficult) when translating informed consent forms - Clinical research practitioners as well as medical translators feel strongly about this issue
2. WHO style guide good resource for medical translators - A valuable resource from WHO for medical translators
3. Measuring translators' performance - What to measure: translators' performance or the final product?
4. Why does my Microsoft Word document display differently on different computers? - A real-world question with real-world answers and tips
5. Psst - over here! I'll sell you translations for $5! - A new "hub for all kinds of mobile workers buying and selling small services" contains low-priced translation offers

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The new frontier in sign language? Gloves.

As patients with disabilities get more more and more attention, one area of development that's picking up are so-called "sign language gloves". These electronic devices converts the complex motions of a sign language into written or spoken words.

One of the latest entries into this field is the "Texting Glove" invented by Google developers Oleg Imanilov, Tomer Daniel and Zvika Markfeld. It is designed with a Lilypad Arduino, flex sensors on the fingers, an accelerometer, a gyroscope and an ADK Board (Android Open Accessory Development Kit). The data is communicated to an Android phone which uses custom software to translate the sign language into text messages.

The Texting Glove is by no means the only contender in this still-developing market niche.

In 2008, students at Carnegie Mellon University developed HandTalk as part of a class research project. And as early as 10 years ago, a high school senior built a prototype of the sign language translator using a leather golf glove with 10 sensors, a small circuit board containing a micro controller, analog-to-digital converter, and a radio-frequency transmitter.

Maybe third time is a charm when it comes to creating an instant, mutually understandable communication link between hearing people and the hearing-impaired world?

[Kudos to Medgadget]

For more on sign language, take a look at the following two articles:

• Medical terminology in ASL
• MobileASL allows deaf people to use sign language when making phone calls

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As the demand for technical, training, marketing documentation, and product labeling increases, so too does the need to deliver this content more quickly and in more languages.

To meet these growing requirements, medical device and pharmaceutical companies are migrating towards structured authoring and content management systems (CMS) that enable the re-use and re-purposing of existing content.

CMS experiences at St. Jude and elsewhere suggest that incremental, managed changes in tools and technologies like CMS can save costs and improve efficiencies. To be effective, this needs to be well planned and not a passionate decision based on the promises/sizzle the software rep sells you on.

This can be challenging though. CMS vendors provide a lot of smoke and mirrors with a huge list of features. At first glance, a CMS may look very attractive and feature rich - but look under the hood and you will see challenges.

And that is if you know how and where to look.

ForeignExchange's own Jason Arnsparger has been showing our clients where to look. And now he is sharing his expertise with medical translation practitioners, clients, and consultants through his audio conference Best Practices for Successfully Implementing a Global Content Management System.

In his presentation, Jason will draw on his experience at Caridian, where he helped lead CMS and translation management system implementations. Jason will provide best practices, real-world information, and actionable advice around CMS implementations. Don't miss this terrific opportunity!

You can register or purchase a recording at FxConferences.com.

And for even more information on content management, take a look at the following articles:

• Case study: DITA implementation for medical translation
• How to prepare a CMS for website translation
• Analytics for multilingual web sites
• Controlled authoring for faster, better, less expensive translations

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We recently wrote about numerals and measurements in Chinese and Japanese texts. While there are lots and lots of numeral systems around the world, most of us are used to the decimal system, expressed using Arabic numerals.

The term "Arabic numerals" can be ambiguous though. As Wikipedia points out, the expression

"...most commonly refers to the numeral system widely used in Europe and the Americas. Arabic numerals is the conventional name for the entire family of related systems of Arabic and Indian numerals. It may also be intended to mean the numerals used by Arabs, in which case it generally refers to the Eastern Arabic numerals."

Numbers came to Europe through the introduction of Algebra from the Arab world (hence "Arabic numbers" versus "Roman numerals"). Despite the fact that we call them "Arabic numbers" though, much of the Middle East uses different symbols for the digits 0-9. These are called Hindi numbers – but actually vary a little bit from Hindi depending on the language used:



So, which version should be used in a medical translation? The short answer is, it depends.

At ForeignExchange, we ask clients if they prefer that we use European digits or "Arabic-Indic" digits. The answer depends on where they intend to use the text. Typically, North African countries prefer European digits, while the Middle East prefers the "Arabic-Indic" style. We suggest European style digits when it is intended for global Arabic usage.

For further information, take a look at these two informative articles:

1. Wikipedia has a good overview
2. Tex Texin provides tons of great information on localizing for right-to-left languages, including Arabic numbers

[Shukran, Megan, for the tip!]


For a detailed proposal on your next clinical, regulatory, or marketing medical translation project, contact ForeignExchange Translations.
 

Latin America's importance in clinical research has been growing steadily. We mentioned in the past how medical device and pharmaceutical companies have made Latin America on of the "big three" emerging research markets. Now, though, the region is looking somewhat less hospitable.

The Buenos Aires Herald reports that GSK was fined 400,000 pesos (roughly US$ 93,000) following a report issued by Argentina's National Administration of Medicine, Food and Technology for the killing of 14 babies during illegal lab vaccine trials conducted between 2007 and 2008.

The finding comes after much controversy around the trial erupted in 2008. GSK maintains that the deaths are not related to the vaccine trials.

Appeals will undoubtedly drag this issue out for a while longer. But that hasn't stopped the resurfacing of protests against global clinical research in general, antidepressant medication more specifically, and GSK very specifically.

GlaxoSmithKline Fined £60,000 for Killing 14 Babies in Sinister Argentinian Drug Trial is the title of one blog post.

Another blog asks "What price a human life?" and then provides the sobering answer: "By my reckoning that's just over £4,000 per child."

Whatever the final outcome in this tragic situation, clinical research is destined to stay controversial: It is likely that proponents will continue to entice moms to earn extra money by participating in clinical trials and opponents will continue to burn down houses of those they view as killers.

[Thanks to Pharmalot for the tip]

P.S. Somewhat related, there is still more trouble for clinical research: Discussing issues with missing clinical trial data, a BMJ editorial derides the "Alice in Wonderland" feel of clinical research efforts.

For expert medical translations of regulatory, clinical, and marketing content in 40 languages - including Spanish - request a detailed proposal from ForeignExchange Translations.
 
 

Well, well, well. While FDA is sloooow about releasing rules governing the use of social media by pharmaceutical and medical device companies, the agency has launched its very own blog, FDA Voice.

FDA Voice was launched in December 2011 as part of a general overhaul of FDA's web site - cleaner, fewer links, more modern. FDA Voice is just one of FDA's interactive media offerings, and it is the agencies second blog, after FDA Transparency Blog.

In the inaugural post, the goal for FDA Voice was stated as follows:

"Through FDA Voice, we hope to give you insights on some of the most pressing public health issues of the day. For example, how does globalization affect the food that we eat? How is the pace of innovation affecting the availability of new medical treatments for you and your family? What does personalized medicine mean for me? And even, what is the latest on food safety for my pet?"

It goes on to say that "As Americans living in the Information Age, we are always looking for new and better ways to communicate". True, true - and where are those social media rules for industry?

[Tip o' the hat to @daphneallen]

For more on this topic, take a look at:

• FDA and Social Media
• Pharma blogs - doomed if you do, doomed if you don't
• FDA atwitter about social media?
• Social Media Policies and Practices for Food and Beverage Marketers
• Pharma (still) fears social networking

Speaking of social media: Be sure to follow, friend, subscribe, and link to ForeignExchange's social media streams to catch all of our musings.