Added value of a systematic approach to regulatory approval

 This article presents a methodology for an efficient decision analysis process, which can serve as a framework for decision making. This may be particularly advantageous in complicated and multi-dimensional matters, with which the regulatory affairs professional is frequently confronted. The most important aspect of this analysis process is that the decision makers are forced to define decision objectives fi rst rather than to start discussing different options. This enables an objective weighing of alternatives against relevant objective criteria. An additional advantage is that the decision analysis process is documented in clear matrices, on the basis of which a risk assessment is performed. The result is a transparent and effective decision making, which can easily be communicated to all parties involved.
Read the full article as published in the Regulatory Rapporteur : The nine steps of rational decision making


The added value of a Facilitator – overcome the 5 biggest barriers to group troubleshooting success

In today´s world of complex technology, dealing with multiple teams of hard-core specialists, it becomes more and more difficult to manage and stay in control. At Kepner-Tregoe (KT), our research and experience show that one specific role can provide a group with the clear focus and strong leadership that brings closure more quickly and initiates the actions to prevent a reoccurrence. That role is the facilitator.

This article will describe the role of a facilitator: the challenges organizations face which call for a facilitator’s help, the skills they need in order to stay in control and the benefits of having this role recognized within an organization.
Read the whitepaper: The added value of a Facilitator