A MESSAGE FROM THE PRESIDENT 

Dear colleagues and friends,

The increasing complexity of
modern medicine together with
 the rapid increase in human
exposure to new medications
over the past three decades has
 uncovered serious weaknesses
 in the system responsible for the
 safety of medicines, devices, and other therapeutic and diagnostic products. These weaknesses have been highlighted by high profile drug withdrawals and safety concerns which receive extensive media scrutiny as well as academic medical and government investigation resulting in public mistrust of safety practices.

The Institute’s mission is in parity with the 2006 IOM report, “To Err is Human”. The chapter “A Culture of Safety” brings attention to the criticality of what the authors refer to as an organization’s “social architecture.” The Institute agrees with the authors and recognizes that structure and culture, as fundamental features of an organization, connect in complex and not easily discernible ways and that this is an area where the Institute’s Roadmap methodology can assist companies with determining how to keep safety risks minimized.

As an independent nonprofit, the Institute also plays a key role in providing leadership to foster communication between all the different stakeholders in the industry. We will be creating forums to stimulate conversations between clinical scientists, post-marketing professionals and industry leaders. To achieve this, we will be creating a continuous agenda to address specific issues and suggestions that have been made since the IOM report was published.

We are planning our first global conference which will be titled “A Call to Action - Steps to Improve World-wide Drug Safety”.

Please contact me if you are interested in participating or presenting.

I look forward to hearing from you,
Axel

aolsen@psisafety.org