ABSTRACT
INTRODUCTION The thalidomide tragedy in the late 1950s and the early 1960s demonstrated the extreme vulnerability of the unborn child and triggered the development of legislation, rules, and guidelines in order to protect women and their unborn children against safety hazards of medicinal products. Since those days the protection of subjects in clinical trials and patients is a crucial element of the development of medicinal products. Special care is taken for vulnerable patient groups such as pregnant women and children.
