RAPS Member: $20
* Contact RAPS Customer Service at +1 301 770 2920, ext. 200, or email email@example.com to learn about the special student registration rate.
The regulatory landscape for drugs, biologics/vaccines, and medical devices is ever changing. Structured data submissions of various product information is now the norm and becoming more prevalent with FDA and other regional health authorities around the world. This educational seminar will identify FDA’s use of SPL and emphasize recent activity related to SPL submissions. In addition, the seminar will explore planned and potential future uses of SPL. In this dynamic regulatory environment, it is valuable to learn insights regarding current practices and gain early information of upcoming requirements. A portion of the seminar will include live audience questions and answers.
Attendees will learn:
• the current use of SPL by FDA for Establishment Registration and Drug Listing
• the current use of SPL by FDA for Medical Device Unique Device Identification (UDI)
• the future expansion of SPL, e.g., FDA REMS, Health Canada for Drug Structured Product Monograph (SPM), others
• Insights into preparing and submitting SPL documents to FDA and Health Canada
This event is coordinated by the RAPS Philadelphia chapter and is intended to encourage knowledge sharing and community development. Breakfast will be available for all attendees and RAC holders may claim 2.5 RAC recertification credits
Special thanks to our program sponsor and host, Reed Tech.
John Lorenc, senior product manager
Gary Saner, senior manager information solutions