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UID:2140535:Event:73242
DTSTAMP:20260524T104212Z
SUMMARY:Clinical Trials - Medical Device FDA's Program 2017
DESCRIPTION:Overview:The topic is device clinical trials. This term re
 fers to the use of medical products on/in humans, in order to gain use
 ful knowledge about the product.\nWhy should you Attend:In spite of th
 e long experience device companies have with clinical trials regulatio
 ns (published 25 years ago), many companies have found this area an ex
 pensive trap. In fact, the only thing more expensive than a good clini
 cal trial is a bad clinical trial.\nAreas Covered in the Session:Intro
 ductionValid Scientific EvidencePhases of Device Human StudiesSignific
 ant/Non-Significant RiskIDE Meaning, Content, ReviewExemption from IDE
  rules\nWho Will Benefit:R&D and Regulatory StaffManagement of R&D Reg
 ulatory\nSpeaker Profile:Anna Longwell is currently principal attorney
  of the Palo Alto Law firm, Longwell and Associates, which specializes
  in Food and Drug law. The firm has expertise in US FDA expectations, 
 regulation and law, affecting the development and ultimate marketing o
 f new medical products, drugs, devices and biologics. They have served
  the regulatory needs of large (>$2 billion/year) divisions of Fortune
  500 companies, and small (4 person) biotech start-ups.\nContact Detai
 l:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@c
 ompliance4All.com\n\nFor more information visit https://medtechiq.ning
 .com/events/clinical-trials-medical-device-fda-s-program-2017
DTSTART;TZID=America/New_York:20170824T100000
DTEND;TZID=America/New_York:20170824T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1420LIVE?channel=medtechiq_Aug_2017_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501420
 LIVE?channel=medtechiq_Aug_2017_SEO
CONTACT:Event Manager
ORGANIZER:Adam Fleming
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562014610?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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