In the world of translation and localization, the life sciences sector is different from any other industry because of the unique and specific nature of its requirements. With regulations changing on a continual basis, a premium is placed on quality above all else. For our Life Sciences Business Round Table in Barcelona, we are delighted to offer a stellar program with a particular focus on the challenges of life sciences localization. In this discussion forum, subject matter experts including clients and vendors will be presenting and sharing their thoughts and experiences on specific processes, as well as discussing the market entrance requirements and challenges in the life sciences industry in general.
Clients, vendors and life science professionals from other disciplines are welcome to participate in this session. However, vendor participation is limited and subject to screening. If you would like to participate in this round table, please contact Clio Schils to obtain the admission code necessary for registration.
Welcome and Introduction
Language in the Life Sciences: Words Matter
Speaker: David Utrilla (U.S. Translation Company)
Life sciences translations require life sciences professionals. Words always matter, but never more so than in the medtech sector. Where mistranslating a slogan may be costly (and funny) in terms of missed opportunity and brand damage, mistranslating a medical term could result in death or injury to members of the public. In this session we will describe experiences from a CEO of a life sciences language service provider and what was learned about the importance of medical expertise in regards to linguists.
Get Lean! Mitigate Risks and Improve Quality
Speakers: Lorena Canduela (Welocalize Life Sciences), Consol Casablanca (Welocalize Life Sciences)
Lean implementation is a transformational process and should support organizational development alongside process improvement. Nonquality in clinical trials (such as late site activation or possible inaccurate data) can be costly and disruptive. To manage and eliminate nonquality in clinical trials, Welocalize Life Sciences works to implement lean methodologies. The result: risk mitigation and improved efficiencies and quality. In this presentation, we will share real world examples and best practices based on client case studies. We will outline the common definitions of waste, show attendees how to identify waste (and language services is just one piece of the puzzle) and share why the cost of getting things wrong is perhaps the biggest area of cost and risk improvement for many organizations.
Brexit and Its Effects on Life Sciences Localization — Update
Speaker: Simon Andriesen (MediLingua)
It may be a while before something happens, but after Brexit the European Medicines Agency (EMA) will surely have to relocate from the United Kingdom. Terminating the very close cooperation of EMA with the British Medicines and Healthcare Products Regulatory Agency (MHRA) in drug registration procedures will be painful for the whole sector. The EMA has been relying a lot on the expertise of the MHRA. The pharma sector will face extra costs resulting from double submissions to both the European Union and United Kingdom. English as the most common source language will hopefully stay the same. A poll by the Association of Translation Companies shows that 90% of UK-based language service providers were against Brexit. Services may become cheaper as a result of the 20% weaker pound, but the ‘continental’ freelancers will become more expensive. The expected negative effects on the UK economy will decrease demand for our services and that is bad for all of us. Participants are invited to share their views or experiences.
The New Medical Devices Regulation — Update
Speaker: Simon Andriesen (MediLingua)
The Medical Devices Directive (MDD) and Active Implantable Medical Devices (AIMD) will be combined into the new Medical Devices Regulation (MDR), which will take final effect in 2019. Quite a few changes for the sector include less self-assessment of its own conformity, more liability for notified bodies. Stricter rules will apply for sure, and whatever this means for life sciences translators will be discussed during this session. The requirement to translate will probably not change. Member-states will have the freedom to select “an official Union language,” but in certain cases it must be “a commonly understood language in the medical field, for all or part of the documents concerned.” In case of multiple languages: “If documents are used in various languages the notified body shall ensure and control that they have the same content.” The Medical Device Coordination Group (the new regulatory body for medical devices) is expected to introduce more monitoring and control, and potentially be as much present as the European Medicines Agency is in the medicines arena.
Telemedicine: How to Work with Interdisciplinary Medical Content and Whether “Universal Soldiers” Are Capable of Coping with It
Speakers: Viktoria Danilina (Palex), Ksenia Krapivina (Palex)
Remote medical consultations and biomonitoring, websites, applications, cloud storage, video conferencing… Telemedicine’s dynamic expansion is international and telemedicine companies inevitably need to localize products and services. Translation agencies now must cope with material combining purely medical (and often highly specialized) content with complex technical components. How do you analyze that content to ensure the accuracy of the translation both from a medical and a technical standpoint? Should translation be entrusted to a linguist, medical professional or IT specialist? Experts equally fluent in all three fields are rare, indeed. Should translators expert in one field be trained in the others, or should we compensate for their shortfalls using glossaries and instructions? That would be difficult to reconcile with ISO 17100, which dictates the use of translators with no less than five years of experience in the relevant field.
Challenges in Terminology Management when Localizing Medical Devices into the South Slavic Languages
Speaker: Zana Boljkovac (Ciklopea)
Translation assets (TMs and TBs) ensure consistency and make a localization process leaner. Their usefulness lies in the automation of the time-consuming manual processes, resulting in higher cost/time efficiency and higher output quality. How do we deal with the industry-recommended advanced practices when localizing into Slovenian, Croatian, Serbian, Bosnian, Macedonian and Bulgarian? These languages are mutually intelligible (at least four of them), but also feature more or less subtle lexical, morphological and syntactical differences, making the localized materials clearly recognizable as the content developed for only one of those separate markets with particular regulatory bodies and legal requirements. In the past, we often encountered previously created translation assets of low quality, featuring mixed terms from these languages, poor general style and inadequate terminology (incorrect, insufficiently clear, wrong technical terms). As regional markets became more mature, setting up communication processes with the client proved to be essential, just like working with specialized teams with advanced linguistic skills and researching competencies.
Break-out sessions followed by best practices presentations and wrap-up.