CEU Saturday
Live event in two locations:
-LIVE: 1 Tampa General Circle, K3601, Tampa, FL 33606
-LIVE STREAMING to: 804 N. Belcher Rd, Clearwater, FL 33765
Please purchase contact hours here
Speakers:
Wendy Portier, RN, MSN, CHC, CHRC, Portier & Associates, LLC
Sara L. VanWyk, MPH, CCRP, RAC
Christina Talley, MS, RAC, CCRP, CCRC
Program Agenda:
- 9:45am – Room opens for seating
- 10:00am – 10:05am: Welcome and Opening Comments presented by Wendy Duncan, ACRP Suncoast Chapter President
- 10:05am – 11:00am: Investigator-Initiated FDA Regulated Research by Christina Talley, MS, RAC, CCRP, CCRC
- Break
- 11:15am – 12:15pm: Simple is Beautiful: SOPs Demystified by Wendy Portier, RN, MSN, CHC, CHRC
- Break
- 12:30pm- 1:30pm: Indicating post-market clinical follow-up from the clinical evaluation perspective by Sara VanWyk, MPH, CCRP
- 1:30pm – 2:00pm: Closing remark
Program Description: Three speakers from varying backgrounds will provide attendees with new perspectives to topics such as best practices for communicating with the FDA, writing SOPs, and post-market clinical follow up study.
Upon completion of this Seminar, attendees 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.
Target Audience: ACRP members and prospective members.
Registration Cost: $15 cost to attend the meeting.
Contact hours: 4.0 ACRP contact hours have been approved for this presentation.
Contact Hour Cost:
- $0 Chapter Members
- $25 ACRP Members
- $40 Non-Members
Membership is not required for online registration of contact hours.
Please purchase contact hours here
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Refund Policy: No contact hour refunds
Level: Basic to Intermediate
ACRP_Announcement_9_2019.pdfRSVP- https://usf.az1.qualtrics.com/jfe/form/SV_78Lbbmv6D1Sx7nL