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DTSTART:19700308T020000
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DTSTAMP:20260413T112455Z
SUMMARY:Conference on Differences between Device and Drug Clinical Res
 earch- A Jeopardy Learning Game
DESCRIPTION:Overview: Drug and device research is confusing and diffic
 ult on its own but when you start combining drugs with devices the reg
 ulatory landscape changes as there are more nuances to deal with. Know
 ing how drug and device studies are each regulated is important in nav
 igating the challenges posed by studies that wish to use both. It is a
 lso important to be aware of current guidance affecting the use of bot
 h drugs and devices in a study as well current guidance affecting the 
 classification of devices.\nWhy should you attend: Information on dru
 gs and devices is plentiful. But, it can also be daunting .The webinar
  will give attendees a foundation and a starting point on which they c
 an build. Learning objectives:\n\nDefine drug research\nDefine device 
 research\nExplore the differences between the two\nDescribe requiremen
 ts when drugs and devices are combined in one study\n\n Areas Covered 
 in the Session:\n\nDefining Drug Research\nFDA approved drugs\nInvesti
 gational drugs\nCompassionate use\n\n\nDefining Device Research\nFDA a
 pproved devices\n510 K devices\nHumanitarian Device Exemptions\nInvitr
 o Diagnostic Devices\nInvestigational Devices\n\n\nFederal regulations
  governing drugs and devices\nGuidance governing drugs and devices\nCo
 mbining devices and drugs into one study\nWhat are the requirements?\n
 What are the regulations and guidance?\n\n\nHow these studies are revi
 ewed\n\n Who Will Benefit:\n\nInvestigators\nResearchers\nResearch Sta
 ff\nStudy Coordinators\nAuditors\nResearch Administrators\n\nSpeaker :
 \nSarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor
  with Washington University School of Medicine. She has developed a co
 mprehensive education program for human subject research which has ser
 ved as a model for other institutions. She crafted budgets, policies, 
 procedures, reporting, and training for the new program. She has initi
 ated the planning, development, authorship and implementation of many 
 human subjects research policies, practices, guidelines, submission an
 d reviewer forms often working with state and federal authorities.   
 She has provided consultation regarding ethical, federal, state, and i
 nstitutional requirements for faculty and staff both in the design and
  execution of their projects and teaches research ethics and regulator
 y affairs and the fundamentals of research management to graduate and 
 undergraduate students. More recently, she lead a task force in the de
 velopment of the Community Engaged Research Program at Washington Univ
 ersity. Dr. Fowler-Dixon has simultaneously served as an Independent C
 onsultant, providing expertise and creating supplemental educational m
 aterials, including a copyrighted workbook.   \nPrice : $139.00\n Con
 tact Info:\nMentorHealth Phone No: 1-800-385-1607 FaX: 302-288-6884  s
 upport@mentorhealth.com Event Link:\n\nhttp://bit.ly/Differences-betwe
 en-Device-and-Drug-Clinical-Research-A-Jeopardy-Learning-Game\n\n\n\n 
 http://www.mentorhealth.com/\n\nFor more information visit https://med
 techiq.ning.com/events/conference-on-differences-between-device-and-dr
 ug-clinical
DTSTART;TZID=America/New_York:20160114T100000
DTEND;TZID=America/New_York:20160114T110000
CATEGORIES:healthcare, compliance, training, provider
LOCATION:Online Event
WEBSITE:http://bit.ly/differences-between-device-and-drug-clinical-res
 earch-a-jeopardy-learning-game
URL:http://bit.ly/differences-between-device-and-drug-clinical-researc
 h-a-jeopardy-learning-game
CONTACT:18003851607
ORGANIZER:Netzealous -MentorHealth
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012368?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Roger St
 even":https://medtechiq.ning.com/profile/RogerSteven
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