Skip to Content

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

Start Date:
Tuesday, 28 November, 2017
End Date:
Tuesday, 28 November, 2017 11:00am
Health & Nutrition

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 ResearchFDA approved drugsInvestigational drugsCompassionate useDefining Device ResearchFDA approved devices510 K devicesHumanitarian Device ExemptionsInvitro Diagnostic DevicesInvestigational DevicesFederal regulations governing drugs and devicesGuidance governing drugs and devicesCombining devices and drugs into one studyWhat are the requirements?What are the regulations and guidance?How these studies are reviewed Learning Objectives :Define Drug ResearchDefine Device ResearchExplore the Differences Between the TwoDescribe Requirements when Drugs and Devices are combined in One Study Who Will Benefit:Those who conduct Clinical Investigations using Drugs and DevicesInvestigatorsResearchersResearch StaffStudy CoordinatorsAuditorsResearch 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 Contact Info:Netzealous LLC -MentorHealthPhone No: 1-800-385-1607Fax: 302-288-6884 Email: support@mentorhealth.comWebsite: Sponsorship:



Organizer Details

Conference organized by NetZealous LLC-MentorHealth

This lesson will be addressing how law firms who work with protected health information need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more

161 Mission Falls Lane, Suite 216

Medical conference data provided by Meetings4Docs | Report a problem

Image Gallery