Understanding the Connection Between Adverse Events and Product Liability Claims

is being presented by Caryn Silverman, Sedgwick, Detert, Partner, with Moran & Arnold LLP and airs on Tuesday, September 28th, 2010. For more details or to register, please visit our site at www.fxconferences.com

As life science companies strive to comply with adverse event reporting requirements, regulatory professionals should understand the product liability implications of doing so. Compliance with FDA regulations will not insulate your Company from product liability claims. In order to navigate the regulatory framework and challenges it creates with a focus on litigation mitigation and prevention, the regulatory practitioner should have a sound understanding of how adverse event reports are affirmatively used by plaintiffs’ attorneys.

This presentation showcases a series of on-going litigations and recent court decisions which highlight the use of adverse event reports, efforts to establish them as evidence of causation and the impact of foreign regulatory decisions. It also addresses the importance of developing specific business practices to thwart these efforts.

Periodic Safety Update Reports: Be Compliant and Cost Effective

is being presented by Dr. Hemendra Misra & Mark Nelson Tyrrell, with PRA International and airs on Tuesday, March 23, 2010. For more details or to register, please visit our site at www.fxconferences.com

Periodic Safety Update Reports (PSURs) are a regulatory requirement in the European Union, Japan, and in an increasing number of ICH and non-ICH countries. The US FDA, in conjunction with the goal to harmonize reporting globally, also accepts a PSUR in place of the Periodic Adverse Drug Event Report (PADER).

Planning and writing of PSURs involve significant effort and costs. In times of peak workload, pressing timelines or competing priorities, maintaining compliance becomes a challenge. Lessons learned from the industry were employed to develop customized strategies to keep up with the associated regulatory, scientific and public health demands.

Real-Time Adverse Event Analysis Using IVR

This audio conference provides an overview of practical considerations regarding the challenges of obtaining adverse event (AE) data, particularly in real-time. A fundamental challenge in the adverse event reporting arena is a lack of, or incorrect, information on patient exposure data and AE incident reporting.

This presentation suggests a strategy for utilizing your IVRS data stream to enhance understanding of patient exposure and enable real-time, proactive decision-making on the progress of the clinical trial. Data already captured in your IVR can provide significant insight into clinical trial performance and improve your understanding of adverse events in your trial. The strategy presented in this audio conference enables you to immediately improve your understanding of AEs without any additional capital expenditure.

Real-Time Adverse Event Analysis Using IVR was presented by Hal Ward, Executive Director Global Head of Drug Safety, with Covance and aired on 2007-08-15. For more details, or to download this conference, please visit our site at www.fxconferences.com

Real-Time Adverse Event Analysis Using IVR

This audio conference provides an overview of practical considerations regarding the challenges of obtaining adverse event (AE) data, particularly in real-time. A fundamental challenge in the adverse event reporting arena is a lack of, or incorrect, information on patient exposure data and AE incident reporting.

This presentation suggests a strategy for utilizing your IVRS data stream to enhance understanding of patient exposure and enable real-time, proactive decision-making on the progress of the clinical trial. Data already captured in your IVR can provide significant insight into clinical trial performance and improve your understanding of adverse events in your trial. The strategy presented in this audio conference enables you to immediately improve your understanding of AEs without any additional capital expenditure.

Real-Time Adverse Event Analysis Using IVR was presented by Hal Ward, Executive Director Global Head of Drug Safety of Covance on 2007-08-15 and is available for download at www.fxconferences.com