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 Montreal, 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.
- Life Sciences Localization: A Fast-evolving and Highly Regulated Industry: How Can We Keep Up?
Speakers: Frank Lin – Becton, Dickinson and Company and Jeff Kiser – Sajan Inc
During this interactive session we will discuss some of the particular aspects pertaining to life sciences localization. Also, what we as clients and suppliers can do to make sure we stay on top of the ever-changing requirements in this highly regulated field. The discussion will evolve but will not be restricted to:
- Life sciences localization readiness
- Localization on a shoestring for life sciences
- Lobbying for time and resources for localization
- Localization project speed in a regulated environment
- Graphics, screen shots and other nontextual items in the localization of medical documentation
- Terminology management in the age of fast-evolving vocabulary
- How to Mature Your Life Sciences Localization Program by Smart Use of Technology
Speakers: Erin Nye – Illumina, Inc. and Lara Daly – Vistatec
At Illumina, the goal is to apply innovative technologies to the analysis of genetic variation and function, making studies possible that were not even imaginable just a few years ago. It is mission critical for them to deliver innovative, flexible and scalable solutions to meet the needs of their customers. As a global company that places high value on collaborative interactions, rapid delivery of solutions and providing the highest level of quality, they strive to meet this challenge. Illumina innovative sequencing and array technologies are fueling groundbreaking advancements in life science research, translational and consumer genomics and molecular diagnostics. Illumina has demonstrated a number of interesting achievements this year after maturing their program over the past four years. The three initiatives that will be discussed in this session are:
- How Illumina is using machine translation to respond to changes in regulations put out by various countries. One example resulted in a five-day turnaround of 55k words from French to English.
- How Illumina improved the Japanese review process, leading to quantifiable results.
- How Illumina created a requestor portal that the company put in place to service the increased internal translation requests while reducing project management hours.
- Plenary Session – New Technologies
Speaker: Sandra La Brasca – AMPLEXOR
During this interactive plenary session we will discuss some of the developments and particularities taking place in today’s technology market. Do we know our clients’ technology requirements, for example: moving to digital content, eDocuments, XML and so on, and do suppliers have the ability to respond accordingly? We will address observations made in the technology markets and discuss these technologies and their application with the group.
- Leveraging the Need for Clinical Expertise — The Successful Implementation of French UI in OACIS
Speaker: Claudia Lefebvre – TELUS Health
Accurate clinical translation was a top requirement for a hospital software application where medical terminology has legal and patient safety implications that are tailored to a French-speaking Canadian province. During this session, TELUS will provide a real-life demonstration of the importance of clinical expertise in a complex technical/scientific environment. The latest version of Open Architecture Clinical Information System (OACIS) represented a paradigm shift in the order management module and posed many challenges, including translation. Using the agile process to ensure efficiency in progress and problem resolution, this client-driven project produced the desired results — beyond expectations!
- Brexit and Its Effects on Life Sciences Localization
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
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.
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.