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P1: Life Sciences Business Round Table

Life Sciences Advisory Board
Co-chair: Richard Korn, St. Jude Medical
Co-chair: Clio Schils, Lionbridge Life Sciences
Simon Andriesen, MediLingua Medical Translations
Brigitte Herrmann, Siemens AG Healthcare Sector
Sandra La Brasca, ForeignExchange Translations
Maarten Milder, Medtronic

Sunday, 3 June 2102

14.00-14.30: Paris Life Sciences Business Round Table: Introductions
Hosts: Richard Korn, Clio Schils

14.30-15.45: Selecting and Implementing a Content Management System in a Regulated Environment
Brenda Inman (St. Jude Medical), Richard Korn (St. Jude Medical), Jennifer Perkins (Lionbridge)
Moderator: Simon Andriesen
Synopsis: This session focuses on the challenges of implementing a content management system (CMS) within a regulated environment. Topics include:

  • How does a life sciences organization decide to implement a CMS? What type of analysis needs to take place?
  • What is the scope of the implementation? What types of buy-in are required?
  • How to convert content effectively from legacy formats to XML
  • How to plan for translation when converting to XML
  • Tips for structuring and validating content
  • Version control for regulatory submissions and traceability
  • Training — how to address the paradigm shift for writing and localization
  • How does a translation memory platform fit into the equation?

Attendees will have the opportunity to question, interact and discuss this process with professionals who have either completed an implementation or who are in the process of implementation.

15.45-16.00: Break

16.00-17.00: Benefits and Challenges of In-Country Review: A Reviewer’s Perspective
Speaker: Moti Daswani (St. Jude Medical)
Host: Richard Korn
Synopsis: This session focuses on the important and regulated work of an in-country reviewer. The presentation highlights examples of what works and what doesn’t work from the perspective of a St. Jude Medical reviewer based in France. Topics include:

  • Types of in-country review that add the most value and reap the most rewards
  • Benefits of on-site review for new platforms
  • The importance of the local language for software and manuals
  • How does in-country review benefit the reviewer and local office beyond the translation process?

17.00-17.45: Creating Capacity or How to Train Health Care Translators Where no Translators Exist
Speaker: Simon Andriesen (Medilingua Translations)
Host: Clio Schils
Synopsis: Many countries have the combination of poverty, poor health, few doctors and no translation infrastructure. Health information in the right language fills the gap between too many people with health problems and the limited capacity of the medical sector. Simon Andriesen of MediLingua developed a course for Translators without Borders (TWB) to train nontranslators to become translators of health information. In April, six groups of trainees took the pilot course at the TWB translation center in Nairobi, Kenya. Simon will share his experiences of teaching translation to nontranslators with wildly varying backgrounds, about what worked and what did not, about lessons learned that others might benefit from, and about how TWB is developing a model that is both sustainable and scalable. He will also dedicate some time to describing the translation market in East Africa (or lack thereof) and how doing business in a totally different culture is challenging, fascinating and addictive.

17.45-18.00: Wrap-up

19.15: Pick-up from the hotel for Paris-by-Night dinner (personal invitations will be sent)

Monday, 4 June 2012

9.00–9.15: Paris Life Sciences Business Round Table: Recap from Day One, 3 June 2012
Hosts: Richard Korn, Clio Schils

9.15-10.30: Language Requirements for EU Medical Device Labels: Regulation, Exception and Risk
Speaker: Helen Colquhoun (Pleiad)
Host: Sandra La Brasca
Synopsis: The European Union (EU) is comprised of 27 member countries and 23 national languages. Medical device labeling must be made available to the user and the patient in accordance with MDD 93/42/EEC, Annex I, Point 13. According to MDD 93/42/EEC Article 4, when a device reaches the final user, regardless of whether it is for professional or other use, member states may require this labeling to be in their national language(s) or in another community language. Translating medical device labels, including instructions for use into 23 languages, can be an expense proposition for a company looking to market their device in the EU. Are there any exceptions? Yes. This presentation will cover the general rules for translation of medical device labeling in the EU: We will discuss the results of a survey regarding the language labeling requirements of a professional-use-only device, that highlights some of the exceptions. We will also discuss the risks of not translating professional device labels into the local language.

10.30-11.00: Break

11.00-12.00 How Changes in Regulatory Requirements Impact the Life Sciences Client and Vendor Community
Speaker: Libor Safar (Moravia Worldwide)
Host: Clio Schils
Synopsis: Needless to say, regulation is one of the major drivers for translations within life sciences. It is also an area that has recently been undergoing major changes. These include changes instigated by regional regulatory bodies (such as Europe’s EMA) as well those developed in individual countries. This session will take a broader perspective on how client organizations are reacting to these regulatory changes and how they impact the language services they require from the vendor community. It will review the services and current trends primarily within the regulatory space for pharmaceutical organizations. Even though the Life Sciences Business Round Table is primarily geared toward the medical device space, Libor will not only draw some interesting parallels between the pharmaceutical and medical device arena but will also compare the type of changes in regulatory requirements between these two life science verticals, offering the audience interesting, hands-on take aways.

12.00-13.30: Lunch

13.30-15.15: Looking Under the Hood of Life Sciences Localization: Competing Companies, Same Challenges
Panelists: Laura Gosselin (Waters Corporation), Babs Sekel (Agilent Technologies, Inc.), Andrew Lawless (Dig-IT)
Moderators: Richard Korn, Clio Schils
Synopsis: As the life science industry grows, localization operations transform rapidly. In this session, representatives from two of the leading global scientific instrument manufacturers, Agilent Technologies and Waters Corporation, discuss challenges and solutions for optimizing and scaling operations. These panelists believe that a close collaboration between the translation vendor community, the buyer community and perhaps academia is necessary to effectively find betterment. The topics for this session include:

  • Development of qualified resources. Both organizations find themselves voicing concerns to their multiple language vendors regarding translation quality only to find they are all in turn beating on the same sole freelance translator and, thus, making the problem worse rather than better.
  • Subject matter expert review. Both organizations are working hard to keep up with the demand for internal small and medium enterprise (SME) to review translation — much too often relying on volunteers and retirees. New approaches to SME reviews need to be developed in collaboration with the vendor community looking at alternative solutions such as social media.
  • Sharing of linguistic assets across vendors. As life science organizations have grown fast, their localization processes have not adapted as rapidly. As a result there are many different vendors working for different departments, all managing and maintaining their own translation memories (TMs) and terminologies. Proactive collaboration between localization vendors is needed to make these individual TMs available and to harmonize any conflict that might exist between them.

15.15-15.30: Introduction to Break-out Sessions and Definition of Groups

  • Content management: How are companies set up to handle the English source content?
  • Change management within an organization
  • Developing a qualified resource pool for translation
  • Subject matter expert review/in-country review
  • Sharing of linguistic assets among vendors

15.30-16.00: Break

16.00-17.15: Breakout Sessions and Presentations (continued)

17.15-17.30: Wrap-up and Evaluation



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