A Basic Overview of the FDA and ICH Guidance and Regulations that exist for conducting Human Subject Research
Date: February 22, 2019
Time: 12pm – 1 pm
Presented by Sheila Austin, MS, CIP
Review principles and regulatory requirements for Good Clinical Practice (GCP).
Discuss roles and responsibilities of the Principal Investigator and study’s staff, protocol compliance, and other criteria for conducting clinical trials.
Examine best practices, examples of GCP noncompliance, and corrective actions for protocol or procedural deviations.
Discuss compliance scenarios related to regulatory and protocol compliance
Location: Communicore 1-11 in Gainesville or Deal Boardroom in Jacksonville (on the fourth floor of the LRC)
Lunch will be provided.
CE: SOCRA members will be credited with 1.0 Continuing Education Units (CEU) for recertification.
- Summarize recent breast cancer statistics
- Describe the breast reconstruction process
- Identify the advantages and disadvantages of using state-of-the-art Perforator Flaps for breast reconstruction
Location: HealthStreet, 2401 SW Archer Road, Gainesville, FL
Free shuttle service is available from select locations at UF (Davis Cancer Pavilion and the cancer hospital), the VA and Hope Lodge. Contact HealthStreet at least one day in advance at (352) 294-4882.
Lunch: Please bring your own lunch OR RSVP to Barb Thomas by Monday, February 25 at firstname.lastname@example.org for a healthful lunch provided with your $4 contribution.
CE: SOCRA members will be credited with 1.0 Continuing Education Units (CEU) towards their Operations/Therapeutic area for recertification