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CLINICAL RESEARCH TRAINING

Comparing Drug and Medical Device Clinical Research Requirements: For Sponsors/CROs

COURSE DESCRIPTION:

The goal of the training is to provide an introduction to medical device research requirements. Comparisons will be made between drug and device development, research requirements in 21 CFR Parts 312 and 812, as well as product accountability and AE reporting differences. The course is structured for individuals moderately experienced in drug development and/or research transitioning into device research.

LEARNING OBJECTIVES:

  • Describe and discuss differences in FDA regulations for investigational new drug and investigational devices
  • Explains roles and responsibilities of Sponsors and Investigators in Investigational Device Exemption studies
  • Identify similarities and differences between Parts 312 and 812
  • Understand the developmental pathways of new drugs and new devices
  • Discuss requirements for product accountability and Adverse Event reporting for device clinical studies
  • Identify the differences in the daily workings of drug and device studies

COURSE OUTLINE

AGENDA: 8:30 am - 4:30 pm

  • Medical Device Regulatory Requirements
    • Comparing Drug and Device Development Pathways
    • Understanding Device Research Requirements: 21 CFR Part 812
    • INDs vs IDEs: Comparing 21 CFR Parts 312 vs 812
  • FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions
  • Day to Day Differences in Medical Device Studies vs. Investigational Drug Studies
    • Assembling and Training Your Team
    • Selection of Sites and Investigators
    • Training of Site Teams
    • Adverse Event Reporting and Product Complaints: ‘Is It Reportable?’
    • Product Accountability: Where does the Pharmacy fit?
    • High Quality Documentation and TMF Considerations
    • Monitoring and Risk-Based Strategies for Compliant Device Studies
  • International Guidance for Medical Devices
    • ISO 14155: Overview of the Standard
    • 21 CFR 812 vs. ISO 14155: Key Differences

TYPE

  •  In Person Training – At IMARC or Your Location
 
CONTINUING EDUCATION CONTACT HOURS (CEUs)
7.0 hours (0.7 CEUs)

KNOWLEDGE LEVELS:

  • Intermediate

WHAT’S INCLUDED

  •  Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References
  • Certificate of Completion

Training Solutions For These Roles

  • Clinical Quality and Compliance Professionals
  • Clinical Research Associates and Project Managers
  • Sponsor/CRO Clinical Operations staff
  • Sponsor-Investigators
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