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

Event Details

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

Time: January 14, 2016 from 10am to 11am
Location: Online Event
Street: NetZealous LLC-161 Mission Falls Lane
City/Town: Fremont,CA,USA
Website or Map: http://bit.ly/differences-bet…
Phone: 18003851607
Event Type: healthcare, compliance, training, provider
Organized By: Netzealous -MentorHealth
Latest Activity: Dec 7, 2015

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Event Description

Overview: 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. Learning objectives:

  • Define drug research
  • Define device research
  • Explore the differences between the two
  • Describe requirements when drugs and devices are combined in one study


Areas Covered in the Session:

  • 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


Who Will Benefit:

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

Speaker :

Sarah Fowler-Dixon, PhD, CIP is 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 lead 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. 


Price : $139.00


Contact Info:

MentorHealth
Phone No: 1-800-385-1607
FaX: 302-288-6884
support@mentorhealth.com
Event Link:

http://bit.ly/Differences-between-Device-and-Drug-Clinical-Research-A-Jeopardy-Learning-Game


http://www.mentorhealth.com/

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