Conference

This session addressed the issues around safety leading to product failures in late stage development and withdrawals of marketed products. An improved risk management process is currently a major initiative at the FDA and has received increasing attention at the EMEA. However there is a need to use more formal approaches to calculating the health gains and losses associated with decisions to delay or withdraw the authorization of products including the possibility if using cost-utility analyses to project the trade-offs and the use of value of information approaches to assess whether additional risk management investments represent value for money to society.