Differences between Device Research and Drug Research 2015 covers topics such as:
- 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?
Differences between Device Research and Drug Research 2015 brings together attendees from:
- Researchers
- Investigators
- Study Coordinators
- Research Staff
- Research Administrators
- Auditors
