How Accurate Adverse Event Reporting is the Key to Subject Safety of Approved Drugs?
WebcastFaculty
OVERVIEW
How Accurate Adverse Event Reporting is the Key to Subject Safety of Approved Drugs? is organized by Compliance4All and will be held on Feb 6, 2018.
Who Will Benefit:
• Principal Investigators and Sub Investigators
• Clinical Research Scientists
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• QA / QC Auditors and Staff
Overview:
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.
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.
Areas Covered in the Session:
• 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
Speaker Profile:
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.
Event Fee: One Dial-in One Attendee Price: US$150.00
Additional details will be posted as soon as they are available.
Who Will Benefit:
• Principal Investigators and Sub Investigators
• Clinical Research Scientists
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• QA / QC Auditors and Staff
Overview:
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.
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.
Areas Covered in the Session:
• 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
Speaker Profile:
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.
Event Fee: One Dial-in One Attendee Price: US$150.00
Additional details will be posted as soon as they are available.
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