Lessons Learned from Recent FDA Submissions
Presented: Friday September 6, 2019, 1:30pm-5:00pm
Carey Smoak has a total of 36 years of experience using SAS. The first 15 years were in academia and the next 21 in the pharmaceutical/biotech and medical device industries. Of the last 21 years, 11 years has been in medical devices and 10 years in pharmaceutical/biotech. He has worked on studies which have led to more than 20 products being approved or cleared by the FDA including NDAs, BLAs, PMAs and 510(k)s. In May of 2006, Carey co-founded the CDISC Medical Device team. He has 60 publications to his credit, and he is a frequent speaker at conferences. Areas of therapeutic experience include atopic dermatitis, thrombosis, in-vitro diagnostic screening and monitoring assays, companion diagnostic assays, vaccines, Alzheimer’s and other therapeutic areas.
This seminar will focus on lessons learned from recent FDA submissions, including recent NDA and BLA submissions. The seminar will begin with an understanding of industry best practices and current requirements for FDA submissions for pharmaceutical, biologic and medical devices. The goal of this seminar is for the participant to learn how to avoid mistakes in FDA submission.
The bar for quality of submissions (for pharmaceuticals and biologics) has been raised since the FDA began requiring CDISC standards for clinical trials which began on or after December 16, 2016. While there is a clear requirement for clinical trials starting on or after the December 16, 2016 date, it is to the advantage of sponsors to strongly consider submitting all studies (including legacy studies) in CDSIC conforming standards.
Avoiding errors in FDA submissions is even more important than ever because of the requirement that CDISC standards be followed. The seminar participant will learn about errors to avoid and will get practical hands-on experience with method on how to manage Pinnacle 21 (community version) errors and warnings.