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.
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
Gary Saner is a Sr. Manager of Information Solutions in the Reed Tech Life Sciences group and is a subject-matter expert on drug labeling, medical device UDI and other structured content reporting to regulatory agencies and commercial organizations. He has over 35 years of experience in the areas of software development, process management and data administration with the last 15 years focused on the life sciences industry. With an understanding of regulations, business requirements and systems, he has helped shape and implement successful solutions at Reed Tech for data management, validation and processing of drug labeling content and medical device UDI data. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team and on the Advisory Board of the Medical Devices Group.
Gerrit-Jan Nijveldt, Global Labeling Consultant, Opus Regulatory
Gerrit-Jan Nijveldt is currently the Labeling Consultant with Opus Regulatory. Gerrit has more than 25 years of experience in global labeling. He has broad expertise in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation, including the labeling for multiple development products (early phase to approval) and labeling for devices. Gerrit has been involved with US SPL since 2005.
Gerrit was also an Associate Adjunct Professor for Temple University School of Pharmacy teaching the Global Labeling in the Quality Assurance and Regulatory Affairs master’s program.
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
LexisNexis Reed Tech
LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels) enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.
For more information, please visit Reedtech.com.
Life Sciences Solutions Driven by Accuracy and Insight
Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.