2014 - Adverse Event Reporting Compliance; The Key to Safe Drug Development / Subject Safety

Instructor: Dr Charles H Pierce
Description:
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.
AE’s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge. To 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.
See Why determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment).
Without a doubt or question, accurate collecting and reporting of Adverse Events (AE’s) is really the single most important function of the Investigational team as far as Subject safety is concerned.
Why Should you Attend:
With the increasing complexity of the Investigational Medicinal Products (IMP’s), it behooves all who have any role in observing Study Participants to know the importance of accurately collecting all AE and SAE data.
Objectives of the Presentation:
The definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more
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
Who can Benefit:
This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
Principal Investigators
Sub Investigators
Clinical Research Scientists (PKs, Biostatisticians, ...)
Safety Nurses
Clinical Research Associates (CRAs)
Clinical Research Coordinators (CRCs)
QA / QC auditors and staff
Clinical Research Data managers
Quick View
http://www.onlinecompliancepanel.com/ecommerce/web...