About us

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Safety Targets, a Health System Consulting Partnership
Founders Dr. Shinji Suzuki and Dr. Hans-Christian Ulrichs, President
Start March 2008
Address Zum Furtfeld 7, 79232 March (Freiburg) Germany
Mission/Services

Healthcare consulting for all aspects of product's safety
Design and implementation of life cycle compatible product safety approaches (processes, organization, science, systems, leadership, culture)
Provision for training and education

Why do we focus on product’s safety?

In the chapter titled "Adverse reactions and post-marketing surveillance" in "Pharmaceutical Medicine" published in 1985¹, J. E. Idänpään-Heikkilä asked the question:

Why do so many surprises occur in the post-marketing phase despite modern methods of drug development, sophisticated medicine and high technology? Are they avoidable?

More than 20 years later in 2008, we have to ask the question again. Some answers to this question may be different today. We will give one answer valid in 1985 and which continues to be valid today.

The knowledge of safety is often incomplete, when a product is introduced to the market. There is some probability of unexpected events during the entire marketing period, which can cause a negative impact on product’s safety.

As a consequence of this situation effective monitoring and regular analyses of product’s safety is mandatory. If critical changes of the product’s safety are observed, special actions need to be initiated. The establishment of an effective drug safety "powerhouse" requires the alignment of processes, organization, science, systems, leadership, culture and more to this goal. The long-term survival of the safety approach and its further improvement have to be ensured. Its integration with the product's efficacy/efficiency approaches has to be anticipated. The size of this task may become very huge. There is no "one fits all-approach". Solutions tailored to the individual company or organizations are needed. Mid-size and small-size units may ask for special solutions. We have initiated and controlled the design and implementation of life cycle approaches for a number of successful products.

What do we think about the integration of efficacy and safety approaches?

The product's safety is closely related to its efficacy. The relationship of the two properties of the product is described by its risk benefit ratio. The ratio may change from research to the expiration of the product's market life. It is our opinion that an integrated approach covering efficacy/safety is most appropriate. New technologies, like predictive efficacy tests or predictive safety tests will provide new opportunities to improve the benefit/risk ratio. ¹ Idänpään-Heikkilä, J. E, Adverse reactions and post-marketing, in Editors E Burley, D. M and Binns, T. B. (1985), Pharmaceutical Medicine