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VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240329T094031Z
UID:2bfaeac2-884d-44f8-862f-bfe01293681f
DTSTART:20210520T100000
DTEND:20210521T100000
CLASS:PRIVATE
DESCRIPTION:Overview:
\nThe webinar will also discuss how to make dete
rminations
\nof whether an adverse event is probably related\, possib
ly
\nrelated\, or possibly/probably not related to a drug or
\nd
evice. \;
\n
\nWhy should you Attend:
\nAre you being c
ited for failure to report safety information\,
\nchanges to the rese
arch plan\, or protocol
\ndeviations/violations or noncompliance to t
he sponsor or
\nthe IRB?
\n
\nAreas Covered in the Session:
\nFDA Regulations
\nOverview of recent changes in regulatory fr
amework
\nGCP R2 Guidelines
\nFDA guidance on electronic source
documentation
\nFDA BIMO Program
\nQuality Management of Data
\nEnhancing Excellence in conduct of Clinical Trials
\n
\nWho
Will Benefit:
\nClinical Research Investigators
\nResearch Nurs
es
\nResearch Managers
\nClinical Research Associates (CRAs)
\nClinical Research Coordinators
\nCompliance Officers
\n
\nSpeaker Profile:
\nGeorge Gasparis has over 35 years of experience
in the
\nadministration or conduct of human subjects research.
\nHe worked at the Office for Human Research Protections
\n(OHRP) for
seven years and served as the Director\, Division
\nof Assurances an
d Quality Improvement from 2000-03\,
\nwhere he led the development o
f the OHRP QI Program and
\nelectronic submission of the Federalwide
Assurance (FWA).
\n
\nEvent Fee: One Dial-in One Attendee Price:
US$150.00
\n
\nContact Detail:
\nCompliance4All DBA NetZea
lous\,
\nPhone: +1-800-447-9407
\nEmail: support@compliance4All.
com
SUMMARY:Investigator Reporting Responsibilities - OHRP
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ACTION:DISPLAY
TRIGGER:-PT1H
SUMMARY:Investigator Reporting Responsibilities - OHRP
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END:VEVENT
END:VCALENDAR