Program Description:
The Association of Clinical Research Professionals (ACRP) Suncoast Chapter relies on great local professionals who are committed to growth and mentorship.
Program Agenda:
9:45am: Room opens for seating
10:00am – 10:05am: Welcome and Opening Comments
10:05am – 11:00am: Investigator-Initiated FDA Regulated Research by Christina Talley
11:15am – 12:15pm: Simple is Beautiful: SOPs Demystified by Wendy Portier
12:30pm- 1:30pm: Indicating post-market clinical follow-up from the clinical evaluation perspective by Sara VanWyk
1:30pm – 2:00pm: Closing remarks
Upon completion of this session, participants should be able to:
- Discuss and review steps in planning Investigator-Initiated research programs, regulatory required responsibilities and best practices for communicating with the FDA or other regulatory agencies.
- Understand the purpose for writing and managing organizational Standard Operating Procedures (SOPs), distinguish between the purpose, policy and procedure statements and increase awareness of techniques that promote compliance with SOPs
- Describe the elements of a post-market clinical follow up (PMCF) study, circumstances where a PMCF study is indicated and where European guidance documents can be found.
TWO LOCATIONS:Live-
1 Tampa General Circle
K3601, 3rd Floor -Bayshore pavilion, Tampa FL 33606
Live Streaming-
804 N. Belcher Rd, Clearwater, FK 33765