CIOMS Working Group IX on "Practical Considerations for Development and Application of a Toolkit for Medicinal Product Risk Management".

The working group was created in April 2010 based on suggestions from a number of drug regulatory authorities and pharmaceutical companies. The plan is to develop a pragmatic consensus guideline to be used by industry and regulators. It will contain a harmonised list of tools for managing risks of medicinal products intended for human use that can be applied globally, as well as the potential application of these tools. The main focus will be on risk minimization. The Working Group is composed of members from the pharmaceutical industry, regulatory agencies, governmental institutions, and academia.

Upcoming meetings planned for this Working Group to be held on 6-7 February 2012 at BfArm, Bonn, Germany.