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Live Webinar on
How Accurate Adverse Event Reporting is the Key to Subject Safety of Approved Drugs? Date: Tuesday, July 23, 2013 Duration:
90 Minutes
Time: 10:00 AM PDT | 01:00 PM EDT Location: Online
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Instructor: Charles H Pierce
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. 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.
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The definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more
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How to know what an Adverse Event is and when to report it or them Knowing the AE types and likelihood of finding "rare" events Understanding laboratory AEs and the "Reference Range" concept Common Mistakes in AE / SAE Reporting Reporting of Adverse Events - when and to whom and the use of AE Terminology systems How to record Adverse Events and assess causality - the algorithm
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Who Will Benefit: l
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Principal Investigators and sub investigators Clinical Research Scientists Safety Nurses Clinical Research Associates (CRAs) and Coordinators (CRCs) QA / QC auditors and staff Clinical Research Data Managers
Click here to register for this webinar
About Speaker Charles H Pierce Consultant, Clinical Research / Drug-Device Development Charles H Pierce MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce serves as an advisor to several clinical research organizations, sits on industry based boards, ... more
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