Translational safety medicine

Abstract This chapter looks at the entire safety value chain of pharmaceuticals, from the start of a drug project in early discovery to the product’s withdrawal, brand, or generic, from the last market. Many different functions, disciplines, and experts are involved in the safe exploration and development of pharmaceuticals. In the absence of a discipline or even a common name for this activity, we called it translational safety medicine. This intends to emphasize the practical and applied nature of the work and stress the importance of clinical and postlaunch safety development. This chapter takes a critical look at current practices, analyses and highlights areas of improvement, and suggests best practice approaches wherever possible. The critical reader may be surprised to see that many opportunities do not relate to cutting-edge science and predictive methods but rather down-to-earth organizational and strategic aspects.