Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices.
Why should you attend: Information on drugs and devices is plentiful. But, it can also be daunting .The webinar will give attendees a foundation and a starting point on which they can build.
Areas Covered in the Session:
- Define drug research
- Define device research
- Explore the differences between the two
- Describe requirements when drugs and devices are combined in one study
Who Will Benefit:
- Defining Drug Research
- FDA approved drugs
- Investigational drugs
- Compassionate use
- Defining Device Research
- FDA approved devices
- 510 K devices
- Humanitarian Device Exemptions
- Invitro Diagnostic Devices
- Investigational Devices
- Federal regulations governing drugs and devices
- Guidance governing drugs and devices
- Combining devices and drugs into one study
- What are the requirements?
- What are the regulations and guidance?
- How these studies are reviewed
- Research Staff
- Study Coordinators
- Research Administrators