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
Structured Product Labeling Workshop
Speaker: Richard BrandtTime: 1:30 PM - 5:00 PM Date: June 26
Track: Post-Conference Workshops
Experience level: All levels
FDA requirements for product labeling have changed radically in recent years. According to the FDA, this trend will continue in an effort to improve application processes and provide better information to health care providers and consumers.
While meeting these new FDA requirements can be challenging from a business process and technical perspective, successful roadmaps have been established that provide organizations with the ability to choose an approach that is right for their needs. The goal of this workshop is to provide attendees with the information needed to start preparing for, and ultimately successfully implementing, an effective SPL strategy.
Topics will include:
- The current status of the FDA requirements for Structured Product Labeling, and what to expect in the next 12 months
- Understanding the technical requirements of Structured Product Labeling
- SPL and your business processes: what to expect and how to prepare
- Options for implementing Structured Product Labeling in your organization
