Online Training 2015 - Accurate Adverse Event Reporting is the Key to Subject Safety of Approved Drugs - By Compliance Global Inc

Overview:
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. To accurately and astutely see and report AE’s is the primary function of the PI.
Why Should You Attend:
With the increasing complexity of the Investigational Medicinal Products (IMP’s), it behoves all who have any role in observing Study Participants to know the importance of accurately collecting all AE and SAE data.
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.
Areas Covered in the Session:
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
Learning Objectives:
Describe what AEs are and what they are not.
Define ‘Reportable Events’ & how to report them.
To know the importance of knowing the Risk a medication places on a population and the new Risk Evaluation and Mitigation Strategies
Understand The commonality of Pre-market and Post market Adverse Event reporting and the different terms and programs
Discover the most common Reporting Errors.
Who Will Benefit:
Pharmaceutical, Biological and device companies with an active pipeline of products and planning on global studies Principal Investigators and sub investigators
Clinical Research Scientists (PKs, Biostatisticians) Research managers
Safety Nurses
Clinical Research Associates and Coordinators
Recruiting staff
QA / QC auditors and staff
Study Monitors
Clinical Research Data managers
Level:
Intermediate
For more detail please click on this below link:
https://www.complianceglobal.us/product/700046
Email: referrals-AT-complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515