Differences between Device and Drug Clinical Research - A Jeopardy Learning Game

Duration: 60 Minutes
This webinar will discuss the differences between device and drug clinical research and the current regulations governing the use of drugs and devices in a clinical study.
Device Research and Drug Research
Instructor: Sarah Fowler Dixon
Product ID: 501007

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 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 as current guidance affecting the classification of devices.

Investigational drugs are governed by 21 CFR 312. Investigational devices are governed by 21 CFR 812. In addition, the FDA has guidance for industry and sponsors on both drugs and device. There is so much information for both drugs and devices that the FDA has dedicated webpages for both. The amount of information can be daunting, especially for those who do not know where to begin.

Areas Covered
  • 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

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.

Objectives of the Presentation
  • Define drug research
  • Define device research
  • Explore the differences between the two
  • Describe requirements when drugs and devices are combined in one study
Who can Benefit
  • Investigators
  • Researchers
  • Research Staff
  • Study Coordinators
  • Auditors
  • Research Administrators
$300
Recorded Session for one participant
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Instructor Profile:
Sarah Fowler-Dixon, PhD, CIP is an Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
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