North Texas Chapter: Guidance for Industry and Investigators: Safety Reporting Requirements for Investigational Devices
Speaker:
- Iris C. MacInnes, Bioresearch Monitoring Specialist, Consumer Safety Officer, Food and Drug Administration, Dallas District Office/Austin Resident Post
Program Description:
This presentation will discuss the regulations for safety reporting of medical devices during an IDE study.
Upon completion of this Seminar, attendees should be able to:
- Define terms related to safety reporting of adverse events related to device studies
- Outline Clinical Investigator, Sponsor and IRB reporting obligations
- Provide safety reporting scenarios and outcomes
Target Audience:
- CRCs
- CRAs
- Investigators
- Auditors
- Project Managers
- Regulatory Affairs/Compliance
- Data Managers (Site, Sponsor, CRO)
- Medical Monitor, Medical Officer, Project Physician
- Quality Assurance
- Clinical Research Administrators
Program Agenda:
- 8:30 – 9:00 am CDT Log on and ensure connectivity
- 9 - 11:00 am CDT Presentation, Questions & Answers
Registration Cost (please click here to register) Registration restricted to the first 100 registrants:
- Chapter Members: $0
- ACRP Members: $0
- Non-Members: $0
Contact Hour Cost:
- Chapter Members: $0.00
- ACRP Members: $15.00
- Non-Members: $30.00
Refund Policy: Not applicable