Date : Tuesday, June 14, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 90 Minutes Price : $245.00
Live Webinar The Risk to Subject Safety of Not Accurately Reporting Adverse Events How to Assess and report AEs and SAEs
Overview: 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.
Register Now Instructor Profile: Charles H Pierce Consultant, Clinical Research / Drug-Device Development,
Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, Charles H. Pierce, MD, PhD, FCP, assessment, and management of Adverse Events occurring CPI is a consultant in the Clinical during the conduct of clinical research with drugs or devices Research / Drug-Device Development utilizing human subjects. See why AE's are one of the key arena specializing in bringing the ways the Clinical Investigator has of monitoring the safety of message of GCP Regulations and subjects or patients in her/his chargeTo obtain 'commonality' Investigator Responsibility to the in reporting, investigative sites require familiarity with one of entire investigative team to help the Adverse Event Terminology systems. As codified in 21 CFR them understand the regulations as 312.64(b), an investigator shall promptly report to the well as the ethics of research sponsor any adverse event that may reasonably be regarded involving human subjects. Dr. Pierce as caused by, or probably caused by, the drug. Determining serves as an advisor to several the relationship between the study drug and an AE requires a clinical research organizations, sits practiced power of observation & great care (good medical on industry based boards, and is VP judgment). of Medical Affairs for Harrison Clinical Research GmbH, a global CRO Areas Covered in the Session: headquartered in Munich. He has been in the Clinical Research l The CFR definitions of Adverse Events, Serious Adverse Industry for 20 years, has been Events, Unanticipated Adverse Device Effects and many involved in developing Phase I & IIa more Clinical Pharmacology Units, l How to know what an Adverse Event is and when to Investigator and staff GCP training, report it or them and medical monitoring in both drug l Understanding laboratory AEs and the "Reference and device studies. ...more Range" concept Related Products l Common Mistakes in AE / SAE Reporting l Reporting of Adverse Events - when and to whom ISO 13485 Gap Analysis Toolkit l The Role of Data safety Monitoring in Protecting Human ISO 13485 Quality Manual Volunteers l How to record Adverse Events and assess causality Intro to ISO 13485 Presentation the algorithm Materials Click here to register for this webinar
ISO 13485 Internal Auditor Checklist more...
Who Will Benefit:
Your Necessity is our Priority
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Principal Investigators and sub investigators Clinical Research Scientists (PKs, Biostatisticians, ...) Safety Nurses Clinical Research Associates (CRAs) and Cordinators (CRCs) Recruiting staff QA / QC auditors and staff Clinical Research Data managers
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