Why Is Drug Induced Liver Injury An Important Mirror Of Drug Safety And How To Spot This Early

Overview: We all know that AE's are one of the key ways the Clinical Investigator

has of monitoring the safety of subjects or patients in her/his charge but some are very rare so the Investigators must be 'heads-up'. Add to this, the large number of "non-drug liver injuries, which easily confound the issue. To be forewarned is forearmed.

Determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment). Determining if an IMP is subject to liver injury separates the best PI's from the rest.

Why should you attend: Whereas Drug Induced Liver Injury (DILI) is usually a rare event that is not found in the usually approval process, there are clues that all investigators and study staff must know. These will be reviewed in this Webinar.

Areas Covered in the Session:

When is an abnormal lab value an AE?

What are Liver Function Tests?

Drug effects on the liver in perspective

What are the risk and host factors for Drug Induced Liver Injury?

Where does acetaminophen (Tylenol) toxicity fit in this process?

How and when do we detect "rare" events?

What are the types of the liver's response to drugs?

How do 'non-drug liver injuries fit in the concept of DILI

Who Will Benefit:

The pharmaceutical and Biological Industry who sponsor pre-approval clinical research and who are responsible for the outcome of the studies.

Principal Investigators and sub investigators

Clinical Research Scientists

Research Managers

Safety Nurses

Clinical Research Associates (CRAs) and Coordinators (CRCs)

Recruiting staff,

QA / QC auditors and staff

Study Monitors

Clinical Research Data managers

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, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been in the Clinical Research Industry for 20 years, has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.

by:Event Coordinator

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