CLINICAL RESEARCH TRAINING

COURSE DESCRIPTION:

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 Shake^TM 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