When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others. Serious adverse events are defined by the FDA as Any adverse experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse experience as it occurred, i.e., it does not include an adverse drug experience that, had it occurred in a more severe form, might have caused death.

Date : 16th September 2015 to 16th September 2015

Place : United States, Fremont

Website :http://www.mentorhealth.com/control/w_product/~product_id=800535LIVE/

Contact Person:Roger Steven

Description:

When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others. Serious adverse events are defined by the FDA as "Any adverse experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse experience as it occurred, i.e., it does not include an adverse drug experience that, had it occurred in a more severe form, might have caused death."

When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others. Serious adverse events are defined by the FDA as Any adverse experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse experience as it occurred, i.e., it does not include an adverse drug experience that, had it occurred in a more severe form, might have caused death. will be held in Fremont,United States on date 2015-09-16

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Deadline for abstracts/proposals : 15th September 2015

Keynote Speakers : 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 fo

Conference Highlights :Areas Covered in the Session: ICH guidelines and Good Clinical Practice (GCP) Department of Health and Human Services (DHHS) guidance Food and Drug Administration (FDA) guidance Definitions Potential effects on consent and the protocol Examples Links to useful resources

Venue :MentorHealth NetZealous LLC, 161 Mission Falls Lane, Suite 216, Fremont contact no: 1800-385-1607 [email protected] www.mentorhealth.com

Check the event website for more details.