Friday Half-Day Class Carey Smoak

Implementing  the Submission Data Tabulation Model (SDTM) for Pharmaceutical Products and Medical Devices: Lessons Learned

Presented: Friday September 7, 2018, 1:30pm-5:00pm

Presented by:
Carey Smoak has a total of 35 years of experience using SAS.  The first 15 years were in academia and the next 20 in the pharmaceutical/biotech and medical device industries.  Of the last 20 years, 11 years has been in medical devices and 9 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 thrombosis, in-vitro diagnostic screening and monitoring assays, companion diagnostic assays, vaccines, Alzheimer’s and other therapeutic areas.  He is also experienced in computer system validation.

In this class, information on the current CDISC requirement for FDA submissions will be shared with the participants.  The class will give an overview of some of the important components in a submission to the FDA – mainly related to SDTM.   An important part of the class will be lessons learned from recent BLA and NDA submissions to the FDA.  Information on the status of CDISC for Medical Devices will also be shared.

Intended Audience: Intermediate

Tools Discussed: No particular SAS software packages will be referenced

Prerequisite: None

Class Outline:

  • Brief overview of:
    • SDTM
    • Therapeutic Area Users Guide (TAUGs)
    • Associated Persons
    • The Seven SDTM Domains for Medical Devices
    • Pharmacogenomics
    • Oncology
  • The CDISC Requirement for FDA Submissions
  • The Current Status of CDISC for Medical Devices
  • Lessons Learned from recent NDA and BLA submissions to the FDA