Drug Clinical Research 2017 - Differences between Device and Drug Clinical Research - A Jeopardy Learning Game

Training Options Duration: 60 Minutes
Tuesday, November 28, 2017 | 10:00 AM PDT | 01:00 PM EDT
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.
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
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
Who Will Benefit:
Those who conduct Clinical Investigations using Drugs and Devices
Investigators
Researchers
Research Staff
Study Coordinators
Auditors
Research Administrators
Speaker Profile
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.
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.
Price - $139
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