Meeting the linguistic requirements for EMA submissions
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
Russia to implement new medical device regulations
Russia is expected to release new medical device regulations within the next few weeks, according to the Massdevice website. The article states that the new regulations will be clearer and have more specific requirements than current ones (e.g., by providing reporting timelines and requirements for post-approval reporting). The updated regulations are also expected to cover the clinical trial
Monthly roundup: Most popular posts in January
After a small break following our busiest year ever, 2012 has started with a bang for us here at ForeignExchange Translations: new team members, new clients, new Learning Unplugged seminars, and new content on Medical Translation Insight. In case you missed them, here are the posts that received the most attention in January:Is Google Translate accurate enough for professional use? - It looks
Complying with EMA's new requirement for medicinal product information
The EudraVigilance Medicinal Products Dictionary (EVMPD) was developed by the European Medicines Agency (EMA) to aid pharmacovigilance activities in the European Economic Area and was designed to support the collection, reporting, coding, and evaluation of both investigational and authorized medicinal product information in a standardized manner. On July 1, 2011, as a step in implementing new
Big in Japan
ForeignExchange has a strong history in the translation of Japanese regulatory and clinical documentation. We have a strong team of qualified native-speaking Japanese linguists and a technical services staff that is experienced in the nuances of PAL-compliant documentation for both the medical device and pharmaceutical industries. We have not only expertly translated content for our clients but
ChangeTracker lets you, well, track changes
In medical translations, the ability to track changes is a key component of delivering quality to clients. And it's not just about the quality per se; for regulatory submissions or some clinic trial work, all changes have to be documented and approved, which means that change tracking is an everyday task for many medical translators, editors, and project managers.ChangeTracker, a new tool for
Upcoming educational events
We've got some great educational offerings in the next few weeks.Translations 101Translation is an arcane discipline, where state-of-the-art technology comes together with a very human process. Done well, medical translations can save lives by getting products to market faster with the vital information needed for safe, correct use. But it can be expensive and time-consuming and translation
Don't ask us. Ask our clients.
For the eleventh year in a row, clients of ForeignExchange Translations say they are very satisfied with the quality and service they have received, and an astonishing 96% say they would gladly recommend ForeignExchange to other companies looking for a translation and localization provider. Since the year 2000, ForeignExchange has conducted a comprehensive annual survey of its clients, to assist
Saudi Food & Drug Authority publishes roadmap to eCTD
The Saudi Food & Drug Authority (SFDA) is still relatively young - it was only established in 2003. That's not stopping the newish 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
Top audio conferences in 2011
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
Dunglish, where Dutch and English collide
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
Monthly roundup: Most popular posts in December
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
Talk to the hand - Turning sign language into words
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,
Taking the hocus pocus out of content management systems
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
Working with numbers in Arabic translations
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
Developing world turns less friendly to drug trials
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
FDA finding its social media voice?
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
Lost In Translation, the song
Talk about staying power. Every once in a while a cliche, a turn of phrase, or an acronym comes along that proves durable. Think OMG. Think Yes We Can. Think Lost In Translation.Come on, is there anybody who isn't yet sick of hearing something or another got lost in translation? As the Translation Guy said:"Lost in Translation" sucks, and I'm talking both film and phraseMaybe, but notwithstanding
2011: Looking back, looking ahead
Another year is drawing to a close. While 2011 was a challenging year, it was also a rewarding one. At ForeignExchange, we have a lot to look back on and be proud of. We opened two new offices in 2011, one in Cambridge, United Kingdom and one in Minneapolis, Minnesota. The diversity of our office locations shows the truly global nature of our business while also demonstrating how ForeignExchange
E-labeling medical devices for the EU market
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical
