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.

Meeting the Requirements: Blending REMS Science & Operational Execution

We invite you to listen to the PRA Risk Management, Epidemiology and Late Phase Operational experts who are currently consulting, designing and conducting REMS activities under the new FDAAA regulations. These experts give insight into current issues concerning REMS, such as risk management activities, observational safety-surveillance studies and performance-linked access programs. They also discuss the potential payoff from the new REMS requirements, as well as which REMS requirements have been proposed for incorporating adaptive designs.

In this audio conference the speakers present various REMS strategies based on a “tiered” approach, as well as some recent case studies. In addition, the presenters cover lessons learned and program components to consider, based on current FDA thinking and requirements for a REMS.

Meeting the Requirements: Blending REMS Science & Operational Execution is being presented by Mark Nelson Tyrrell, Kathleen Kushner & Jerome Wilson, Director, Safety and Risk Management, Scientific Affairs Director & Senior Scientific Affairs Director, with PRA International and airs on Tuesday, June 16, 2009. For more details, please visit our site at www.fxconferences.com