Overview
Continuing Education credits are not available for the archived offering.
This archived webinar is available for purchase through December 1, 2015.
Broadcast time: 1 hour 37 minutes
Drug-Induced Organ Injury Series
Establishing safety of new drug candidates remains a major challenge at every stage of the development process. This webinar series will focus on drug injury to the heart and kidney, and will explore the use of biomarkers as tools and the regulatory history on biomarker use. Additional insight will be provided on the assessment of proarrhythmia risk and the clinical assessment of risk. This webinar series should be attended by all those with responsibilities that span the entire life cycle of a drug, whether those responsibilities are directly in drug safety or are in related departments.
The “Drug-Induced Injury of the Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline” meeting took place in May 2014. These webinars are based on sessions from the meeting.
Program committee members, Pradip K. Paul, MD, MS, Strategic Pharmacovigilance and Risk Management; William W. Gregory, PhD; Pfizer; Norman Stockbridge, MD, PhD, OND, CDER, FDA, and Aliza M. Thompson, MD, OND, CDER, FDA spearheaded this initiative to continue the conversation on these very important and timely topics. We hope you all take advantage of this opportunity to participate in one or all of the upcoming webinars.
About this series.
Impact on Drug Development of Novel Translational Safety Biomarkers for Improved Detection of Drug-Induced Acute Kidney Injury
The scientific and business benefits being realized from qualifying improved translational kidney safety biomarkers for drug development, focusing on animal study data that have been developed to support the claims that several novel biomarkers can outperform conventional biomarkers for monitoring potential drug effects on renal function will be discussed during the webinar. Also, addressed is the experiences of using novel renal biomarkers in early clinical studies, highlighting some of the challenges and presenting options for optimizing early clinical study designs.
Other webinars in this series:
Program Committee
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Gary S. Friedman, MD Director, Clinical Affairs, Specialty Care Medicines Development Group
Pfizer Inc., United States
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Ways to register
Series Discount Available*
Save when you purchase two or more webinars in this series.
Buy two, save 10%
Buy three, save 15%
*Discount includes archived webinars in this series. Order must be placed in one transaction for savings to be applied.
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Cancellations:
No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.