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DTSTART:19700308T020000
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UID:2140535:Event:66516
DTSTAMP:20260505T205335Z
SUMMARY:Serious Adverse Events (SAEs): What it is and How to Handle
DESCRIPTION:Overview: When conducting clinical trials it is important 
 to understand and be able to identify serious adverse events (SAE). Th
 ese are events that are serious, likely related to the study drug, dev
 ice, treatment or procedure, and increase risks to participants or oth
 ers.\nSerious adverse events are defined by the FDA as \"Any adverse e
 xperience that places the patient, in the view of the initial reporter
 , at immediate risk of death from the adverse experience as it occurre
 d, i.e., it does not include an adverse drug experience that, had it o
 ccurred in a more severe form, might have caused death.\" Although thi
 s definition seems clear, there are words within the definition itself
  that have to be understood in order to ensure compliance. Who is the 
 initial reporter? What is an adverse experience? Is an adverse experie
 nce different or the same as an adverse drug experience? How do you kn
 ow if a more severe form as occurred? Is death the SAE or is the cause
  of death the SAE? This webinar will help sort out all these issues a
 nd get you to a better understanding of what needs to be reported to w
 ho. Why should you attend: Regulations and guidance can be overwhelm
 ing and seem conflicting when it comes to handling serious adverse eve
 nts, it is important to know when and what needs to be submitted, revi
 ewed, and approved by an Institutional Review Board (IRB) and what can
  be handled by the investigator as non-reporting of events that are co
 nsidered reportable can lead to issues related to non-compliance.Areas
  Covered in the Session:\n\nICH guidelines and Good Clinical Practice 
 (GCP)\nDepartment of Health and Human Services (DHHS) guidance\nFood a
 nd Drug Administration (FDA) guidance\nDefinitions\nPotential effects 
 on consent and the protocol\nExamples\nLinks to useful resources \n\n
 MentorHealthcontact no: 1-800-385-1607Event Link:http://www.mentorheal
 th.com/control/w_product/~product_id=800535LIVEfax no: 302-288-6884sup
 port@mentorhealth.comwww.mentorhealth.com\n\nFor more information visi
 t https://medtechiq.ning.com/events/serious-adverse-events-saes-what-i
 t-is-and-how-to-handle
DTSTART;TZID=America/New_York:20150916T100000
DTEND;TZID=America/New_York:20150916T110000
CATEGORIES:webinar
LOCATION:Online Event
WEBSITE:http://www.mentorhealth.com/control/w_product/~product_id=8005
 35LIVE
URL:http://www.mentorhealth.com/control/w_product/~product_id=800535LI
 VE
CONTACT:8003851607
ORGANIZER;CN="Roger Steven":https://medtechiq.ning.com/profile/RogerSt
 even
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012549?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Roger St
 even":https://medtechiq.ning.com/profile/RogerSteven
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