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Program Titles

A Comparison of Three Visual Help Authoring Tools

A Practical Guide to Capturing, Organizing, and Securing Your Documents

Authoring Assistance

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

Collaboration Via Reuse

Content Technologies Market

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… What’s Your Rescue Plan?

Ensuring Information Quality

Globalization Issues with Medical Device Embedded Systems

Handling DITA Topics and Translation in a Regulated Industry

Health Information Portals

Healthcare and the Internet

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

SPL Beyond CDER

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

Web 2.0 and Healthcare

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] Adobe Captivate

[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

[Workshop] Simplified Technical English

[Workshop] Writing Reusable Content

Session Details

Centralized Translation Processes: Overcoming Global Regulatory and Multilingual Content Challenges

Speaker: Inna Kassatkina
Time: 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.