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… What’s 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
Changes to Labeling Requirements for Pharmaceutical and Medical Equipment Professionals: Creating SLP-compliant Labels in Microsoft Word
Speaker: Richard BrandtTime: 11:30 AM - 12:30 PM Date: June 24
Track: Software Demonstrations
Experience level: All levels
A 15 month-old law extends the current XML prescription drug labeling requirements to OTC, medical device, and veterinary manufacturers. The FDA has not established a date for compliance yet, but it is a major topic of discussion with many observers expecting early2009 as a possible implementation date. The good news is that SPL no longer represents unknown territory. The experience of prescription drug companies to date has provided lessons-learned and sound tactical or strategic approaches to SPL.
In.vision is the leading provider of SPL authoring software, with a client list that includes major pharmaceutical companies and the FDA. This session is designed to provide both a survey of the SPL requirements, and a walk-through of the actual authoring experience of creating SPL compliant labels in Microsoft Word.
