North Texas Chapter: FDA Updates and Data Integrity & BIMO – Building Quality into Your System
Event Description:
This program will highlight key laws and regulations (or the absence of laws and regulations) that directly or indirectly affect the research industry. It will also explore the importance of data integrity and its impact on research studies and discuss the role in making data quality an integral part of the clinical site’s overall research process.
Speakers:
David Vulcano MBA, MSW, BS/Vice President, Research Compliance & Integrity/HCA Healthcare, Brentwood, TN
Michelle Hines, MS, RD, Supervisory Investigator/Regulatory Office FDA/Office of Regulatory Affairs/Office of Tabacco & Medical Products/Division of Bioresearch Monitoring II, Dallas TX
Event Learning Objectives:
- Understand FDA laws, regulations & guidance, & analyze the impact on research.
- Explain the similarities and/or differences between data integrity and data quality finding examples found in research studies.
- Discuss ways to ensure data quality in clinical trials.
Event Agenda:
- 8:30 a.m., CT – Log in
- 9:00 a.m. - 12:00 p.m., CT – Presentations & Extended Q&A
Registration Information:
Click here to register for the event.
- Early Bird Rate (until 11/10/23): $5
- Regular Rate (11/11 - 11/17): $15
Contact Hour Information:
This event will offer 3 contact hours. Click here to purchase contact hours. Please purchase and retrieve your contact hours before December 18, 2023
- Chapter Members: $0
- ACRP Members: $15
- Non-Members: $30
To receive contact hours: Purchase the contact hours and attend the program. After attending the event, log on to the ACRP website and visit learning.acrpnet.org/my/. Select your event, confirm attendance and take the event evaluation between 1 and 30 days following the event and obtain the online certificate." After 30 days, contact hours are no longer available.