Program by Day
Program by Track
Program Titles
A Comparison of Three Visual Help Authoring Tools
A Practical Guide to Capturing, Organizing, and Securing Your Documents
Being Smart About Global vs. Local During Clinical Trials
Bringing User Experience to Medical Devices
Centralized Translation Processes
Changes to Labeling Requirements for Pharmaceutical and Medical Equipment Professionals
Creating and Serving Relevant Content
Creativity or Confusion Factor?
Developing a Collaborative Team
Developing a Unified Enterprise Content Model
Drowning in a Sea of Information Whats Your Rescue Plan?
Globalization Issues with Medical Device Embedded Systems
Handling DITA Topics and Translation in a Regulated Industry
How to Enforce Standards in Life Sciences Documentation
How to Maximize Content for a Global Audience
How To Select and Procure Content Technologies
Marketing in a Connected World
Migrating to Structured Authoring on Your Way To XML
Phase 2 - What’s Next for Life Sciences and Enterprise Content Management
Preparing Compliant eCTD Submissions
Structured Content Beyond the Label
Structured Product Labeling Workshop
The Best Global Medical and Pharmaceutical Web Sites (and Why)
Transforming Technology Transfer and Recipe Management
Unlocking Handwritten Information from Medical Records
What’s New in Collaboration Tools
Writing Reusable Content for Different Audiences
XML-Based Collaboration with Office 2007
Your Global Audience is Already Here
[Case Study] Physician, Know Thy User
[Workshop] Analyzing Your Deliverables
[Workshop] Content Modeling for Life Sciences Content
[Workshop] Creating High Quality Content that Communicates Across Language Barriers
[Workshop] Do you Know Adobe Acrobat?
[Workshop] Games To Explain Human Capability and Limitations
[Workshop] Learning DITA From Concept to Implementation
[Workshop] Product Life Cycles in the Life Sciences Industry
Session Details
Centralized Translation Processes: Overcoming Global Regulatory and Multilingual Content Challenges
Speaker: Inna KassatkinaTime: 2:00 PM - 3:00 PM Date: June 24
Track: Pharmaceuticals
Experience level: All levels
Accurate translations of clinical trial documents play an important role in meeting global product demands. If not, mistakes from poorly done translations can result in product delays, cost overruns, or, even worse, contribute to malpractice or product liability lawsuits. Specifically, adhering to a documented process of free and informed consent as well as the proper translation of ICFs are crucial for protecting the subjects human rights. Communication problems and issues of true and informed consent may arise when a trial involves non-English speaking subjects. In this session, attendees learn to overcome the challenges of managing global content and to streamline and centralize the translation process.
- Managing Global Content: Specifically, in global clinical trials there is an overwhelming amount of information to manage. From source content creation to content management in multiple language, any life sciences professional involved in the global clinical trial process can benefit from project management approach to content management from regulatory, financial, and efficiency perspectives.
- Streamlining Processes: Companies that are successful in managing translation of consent forms and other clinical trial materials, follow strict quality assurance procedures, be it with their on-staff translators or through a third-party translation agency. All documents are first translated, then edited, and finally proofread by experienced professional translators with clinical research background. In addition to that, translation memory tools are used, which reduce translation costs, ensure greater consistency of terminology throughout the document lifecycle, and contribute to faster turnarounds.


