Why is Drug Induced Liver Injury an Important Mirror of Drug Safety and How to Spot this early

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    Live Webinar           on

      Why is Drug Induced Liver Injury an Important Mirror of Drug Safety
      and How to Spot this early

    Date & Time:                                                                                                                   

     Tuesday, January 8, 2013           10:00 AM PST | 01:00 PM EST
                                                                                              Register Now                         
     Duration: 90 Minutes               Instructor: Charles H Pierce

     Location: Online                   Price : $195.00     (for one participant)

                                                                                         Instructor Profile:
                                                                                                    Charles H Pierce
     Overview:                                                                                      Consultant, Clinical
    Ferreting out which Investigational Medicinal Products (IMP) might cause                      Research / Drug-Device
    significant liver injury is not an easy process partly because there is                            Development

    confusion about how to test for liver injury and part because these AEs              Charles H. Pierce, MD, PhD, FCP,
    are rare (in the 1:10,000+ area) or "idiosyncratic" in type so are not               CPI is a consultant in the Clinical
                                                                                         Research / Drug-Device
    picked up in the usual drug development process testing.
                                                                                         Development arena specializing in
                                                                                         bringing the message of GCP
    We all know that AE's are one of the key ways the Clinical Investigator              Regulations and Investigator
    has of monitoring the safety of subjects or patients in her/his charge               Responsibility to the entire
    but some are very rare so the Investigators must be 'heads-up'. Add to               investigative team to help them
    this, the large number of "non-drug liver injuries, which easily confound            understand the regulations as well as
    the issue. To be forewarned is forearmed.                                            the ethics of research involving
                                                                                         human subjects. Dr. Pierce serves as
                                                                                         an advisor to several clinical
     Areas Covered in the Session:                                                       research organizations, sits on
                                                                                         industry based boards, and is VP of
                                                                                         Medical Affairs for Harrison Clinical
        l   When is an abnormal lab value an AE?                                         Research GmbH, a global CRO
        l   What are Liver Function Tests?                                               headquartered in Munich. He has
                                                                                         been in the Clinical Research
        l   Drug effects on the liver in perspective
                                                                                         Industry for 20 years, has been
        l   What are the risk and host factors for Drug Induced Liver Injury?
                                                                                         involved in developing Phase I & IIa
        l   Where does acetaminophen (Tylenol) toxicity fit in this process?             Clinical Pharmacology Units,
        l   How and when do we detect "rare" events?                                     Investigator and staff GCP training,
        l   What are the types of the liver's response to drugs?                         and medical monitoring in both drug
        l   How do 'non-drug liver injuries fit in the concept of DILI                   and device studies. ...more

    Click here to register for this webinar
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     Who Will Benefit:
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        l   The pharmaceutical and Biological Industry who sponsor pre-
            approval clinical research and who are responsible for the
            outcome of the studies.
        l   Principal Investigators and sub investigators                                                  
        l   Clinical Research Scientists
        l   Research Managers
        l   Safety Nurses
        l   Clinical Research Associates (CRAs) and Coordinators (CRCs)
        l   Recruiting staff,
        l   QA / QC auditors and staff
        l   Study Monitors
        l   Clinical Research Data managers

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,

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