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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
SPL Beyond CDER: Lessons Learned from the Pharma Experience
Speaker: Don BridgesTime: 3:30 PM - 4:30 PM Date: June 24
Track: Pharmaceuticals
Experience level: All levels
The Structured Product Labeling (SPL) era is drawing closer as FDA prepares to require SPL for divisions beyond CDER. SPL is a format for Labeling based on XML that allows better (more complete) and faster communication of the content of labeling to FDA, NLM, and consumers. Just as Pharma was grasping for solutions three years ago (before the October 2005 mandate for SPL), OTC, Veterinary, Devices, Biologics, etc. are asking the same questions now that the mandate is on the horizon. Hoping to leverage past pharma experience, this panel discussion is a unique opportunity to learn the basics of preparing an Structured Product Labeling (SPL) strategy and answering the basic question of “what do I need to know about SPL”.
Each sponsor will cover:
- Company background/situation
- SPL approach decision
- hat you wished you had known before the SPL era that you didn’t know
Then it’s the attendees turn to ask questions.
