Differences between Device Research and Drug Research 2015

Topics

• FDA approved drugs
• Defining Drug Research
• Compassionate use
• Investigational drugs
• FDA approved devices
• Defining Device Research
• Humanitarian Device Exemptions
• 510 K devices
• Investigational Devices
• Invitro Diagnostic Devices
• Guidance governing drugs and devices
• Federal Regulations governing drugs and devices
• What are the requirements?
• Combining devices and drugs into one study
• How these studies are reviewed
• What are the regulations and guidance?

Who should Attend

Attendees from:

• Researchers
• Investigators
• Study Coordinators
• Research Staff
• Research Administrators
• Auditors