North Texas Chapter: Guidance for Industry and Investigators: Safety Reporting Requirements for Inve

When:  Sep 24, 2022 from 09:00 AM to 11:00 AM (CT)
Associated with  ACRP North Texas Chapter

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:

  1. Define terms related to safety reporting of adverse events related to device studies
  2. Outline Clinical Investigator, Sponsor and IRB reporting obligations
  3. 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

Location

Dial-in Instructions: