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

Maximizing Results Through Your Workforce: Hire More People or Develop the People You Have?

In our current business climate it seems like everyone is trying to do more with less, and that includes people at your workplace, too. So how can you maximize results when people are overwhelmed and stressed out? Through strategic talent development - and engaging people to further develop their skills and enhance their desirability to their employer. What if you don't have time to develop people? Is this time to strategically add people to your team? You bet.

Through GAP Analysis and Case Studies you will discover how to evaluate your current team, maximize their production, and produce better results. In this session, we will go step by step through a skills inventory and GAP Analysis to help you clarify your team member’s strengths and areas of development to meet or exceed your corporate objectives, and help you determine whether or not you need to hire to supplement team strengths.

Maximizing Results Through Your Workforce: Hire More People or Develop the People You Have? is being presented by Laura Raynak, Managing Director, with Raynak Executive Search and airs on Wednesday, January 21, 2009. For more details, please visit our site www.fxconferences.com