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 Dublin, 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 Regulatory Updates and Their Impact on Translation Requirements
Speaker: Libor Safar-Moravia Moderator: Clio Schils
These are exciting times for regulatory professionals in the medical devices, pharmaceuticals and clinical trials industries. A number of new regulations that have been years in the making are coming or are set to come into force, while others are currently being developed or updated. This includes the new European Union medical device regulations ISO 13485:2016 and the global roll-out of UDI, as well the regulation of eHealth, healthcare apps and other innovative applications of technology in the medical space. Many of these regulations have a direct or indirect impact on requirements for life sciences translation. In this session we will focus on the current regulatory updates and offer guidance on their impact while inviting a discussion on their practical application in the context of translation and localization.
Panel Discussion — Best Practices for RFPs in Life Sciences
Speakers: Simon Andriesen-MediLingua, Wouter Leeuwis-Waters Corporation Moderator: Maria Kania-Tasak
Have you ever tried to set up a request for proposal (RFP) for translation services in the life sciences space? You’ve got to build the process and generate questions that satisfy procurement, marketing or other departments in highly regulated companies. Maybe you’ve assembled your questions only to find that they’re not helpful for translation vendor selection or are too long and complex to execute. It can feel like wrestling with an unruly beast. During this panel discussion, we will discuss and define the best practices on how to create an effective life sciences RFP procedure. Expert panelists will answer questions to guide you in setting up a solid RFP for life sciences translation providers so that requirements are clear to them, life sciences companies’ expectations are met and ultimately the right vendor is selected.
Bridging the Divide between Content Creation and Localization in Medical Devices Content
Speaker: Carolina Arias-RR Donnelley, Ann Rockley-The Rockley Group Inc. Moderator: Sandra LaBrasca
Too often there is a difficult relationship between content creators and localization teams, and sometimes it is an adversarial relationship. Both sides want to create the best possible content but may lack an understanding of how to communicate best practices and work toward a common solution. Change is hard and communicating those changes even harder. To succeed, we must create an open dialog and educate stakeholders to understand the change, the benefits of the change and help them to work in a new way. This session will be an interactive discussion of change management best practices for medical device content.
Standards in Life Sciences: Update — Implementation — Assessment
Speaker: Alex Lik-A-CLID Ltd. Moderator: Simon Andriesen
In this session we will share more regarding the standards that currently apply for both life sciences companies and language service providers (LSPs) and also address the recent updates regarding ISO 9001 and ISO 17100. In addition, you will hear more on how to build a good quality management system and discuss with our presenter the pros and cons of external consulting versus internal resources to do this job. Finally, implementation and assessment of all of the above: how is this taking shape, seen from the auditor’s, buyer’s and LSP’s angle.
The second half of the afternoon will be dedicated to breakout-sessions that will allow the attendees to further discuss one of the above or other agreed topics in more depth with their peers and to contribute to defining best practices and useful tips and tricks.
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.