Overview
This archived webinar is available for purchase through November 1, 2015.
Broadcast time: 1 hour 25 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.
Facets of Drug-Induced Kidney Injury and Regulatory Perspective
This webinar will describe how novel translational kidney safety biomarkers may be important new tools for distinguishing between altered kidney function (due to altered renal hemodynamics and inhibition of specific renal transporters) and acute kidney injury, providing an advantage over serum creatinine alone. Clinical data as well as data from animal toxicology studies of drugs with pharmacodynamic activity on renal blood flow and glomerular filtration and the association of novel translational kidney safety biomarkers with acute and chronic kidney injury will be presented. The regulatory history of the preclinical renal biomarker qualification and perspective on the utility of renal safety biomarkers in drug development will also be discussed during the webinar.
Other webinars in this series:
Program Committee
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Melanie Blank, MD Medical Officer, Division of Cardiovascular and Renal Products, OND, CDER
FDA, United States
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Ways to register
Series Discount Available*
Buy 2 webinars in this series and save 10%
Buy 3 webinars in this series and save 15%
*Order must be placed in one transaction for savings to be applied.
- Individual registration is a license for ONE internet login allowing one viewer.
- Group site registration is a license for ONE internet login allowing multiple viewers from one location.
- Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.
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.