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The Risk to Subject Safet

Zoom in  Zoom out Publish date: 2011-06-06   Hits: 85   Status: Status
Date 2011-06-14 to 2011-06-14
City Wilmington
Address 1000 N West Street | Suite 1200
Exhibition hall Online Training Webinars
Sponsor GlobalCompliancePanel
Undertaker GlobalCompliancePanel

Event Description
Title: The Risk to Subject Safety of Not Accurately Reporting Adverse Events - How to Assess and report AEs and SAEs - By GlobalCompliancePanel

The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately.

Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects. See why AE's are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his chargeTo obtain 'commonality' in reporting, investigative sites require familiarity with one of the Adverse Event Terminology systems. As codified in 21 CFR 312.64(b), an investigator shall promptly report to the sponsor any adverse event that may reasonably be regarded as caused by, or probably caused by, the drug. Determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment).

Why Should You Attend: All CRO's, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the ICH processes and why the Sponsor's / CRO's Monitors are so important.

Contact information
Contact: 800-447-9407
Address: 1000 N West Street | Suite 1200
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