Description:
Preparing patient and public-facing US drug product information has multiple challenges including the absolute requirement for an accurate representation of the US Food and Drug Administration (FDA) approved text and flowing content into multiple output formats for electronic, web and paper distribution. Working within the FDA regulatory regulations, many drug manufacturers have multiple process steps using internal and external resources to generate messaging for users (healthcare providers, patients) and for promotional advertising including web-based and printed materials. Providing these materials facilitates the drug product presence in the marketplace and in some cases is an FDA requirement. In this webinar, the featured speaker will explore the utilization of the structured product labeling XML format for providing drug-related information to patients.
This webinar will look at the basic regulatory and business composition and publishing requirements, with a specific focus on the structured product labeling XML composition. In addition, they will summarize an alternative process that is inherently more accurate and faster than traditional processing methods using state of the art tools.
Who Should Attend:
- Drug Information Composition and Publishing Staff
- Drug Labeling Team Members
- Regulatory Affairs/Operation Leaders
- Product Managers and Marketing Leaders
- Global Strategy Business Managers
- Quality Leaders
- Regulatory Ad Promo
What You Will Learn:
Attendees will be introduced to:
- A review of the US Food and Drug Administration (FDA) drug information regulations
- An enhanced drug information processing method
- Time and cost savings in revamping the composition approach.
