Synopsis:Building on the success and experience from 14 previous conferences, the 2010 Seattle Life Sciences Business Round Table will explore best practices specifically for the life sciences sector. Clients with an undisputable track record in the life sciences industry will present and share their thoughts and experiences on the challenges and different aspects of medical device localization, the particular set of requirements as well as the challenges that these requirements create.
Topics will include but are not restricted to:
Best practices for document development and translation in the life sciences industry: We will address key issues in generating content for a global audience in the life sciences — best practices for use of controlled English vs. simplified English, checklists for writing and use of technologies to accelerate the translation life cycle.
APAC regulatory requirements, in particular for countries such as Korea, China, Taiwan and Japan, and the challenges posed for localization; Is China catching up? Is localizing medical devices for Japan a different animal?
Terminology management in life sciences: Terminology management is a commonly used quality assurance step for accuracy, and many life science companies have their own solution. This session deals with the different developments and approaches used in the United States and Europe.
Break-out sessions in the afternoon will offer the opportunity to exchange views on the presented topics. In small groups, participants will discuss how the observations and the lessons learned during this round table may be converted into a range of best practices that are applicable to and compatible with each participant’s own specific corporate environment.
Agenda
9:00-9:15
6th Life Sciences Round Table: Introduction
Speaker: Clio Schils (Lionbridge)
9:15-10:30
The Global Optics: Best Practices for Document Development and Translation in the Life Sciences
Speakers:Beth Tripp (Abbott Medical Optics), Jon Bove (Moravia Worldwide) Synopsis: According to the FDA, over 65% of FDA-regulated clinical research for leading life sciences companies will be conducted outside the United States. This session will address key issues in generating content for a global audience in the life sciences: best practices for use of controlled English vs. simplified English; checklists for writing; and use of technologies to accelerate the translation life cycle. The case study presented in this session will focus on the key touch-points between content creation and translation specifically in the highly regulated life sciences industry where the aim is to reduce the total cost of multilingual translation while keeping the medical information 100% accurate.
10:30-11:00
Coffee Break
11:00-12:00
Terminology Management in the Life Sciences: United States versus Europe
Speaker:Barbara Inge Karsch (BIK Terminology) Synopsis: Consistency and precision are of utmost importance in the authoring and translation process of life sciences documentation. Terminology management is a commonly used quality assurance step for accuracy, and many life science companies, both in the United States and Europe, have a terminology solution. The difference is that in Europe many companies seem to be going with the traditional linguistic solution while in the United States medical informatics experts are more sought after. Is this observation correct? If it is, what are the factors that led to the different developments? What are the pros and cons of each solution?
12.00-1:30
Lunch Break
1:30 - 2:15
Labeling for Asia: Part 1 — How the Regulatory Structure in China and Japan Affect Labeling and Localization for Medical Device Clients
Speakers: Jason Arnsparger (CaridianBCT), Jennifer Perkins (Lionbridge)
Synopsis: In this two part session we will briefly review the medical device regulatory processes in China and Japan and how these regulations affect labeling and localization needs for product release in these locales. After a brief overview of regulations, the participants will have the opportunity to break into smaller groups to discuss their particular challenges with labeling and localizing for Asia or a more in-depth discussion of the regulatory agencies and how the systems are structured.
2:15 - 3:00
Labeling for Asia: Part 2 — Break-out Session
3:00 - 3:30
Coffee Break
3:30 - 5:00
Break-out Sessions: “Pains and Gains" in Life Sciences Localization
