To be able to MANAGE ADVERSE EVENTS effectively and preferably at an early stage, they need to be investigated before LAUNCHING it to a broader audience. It is common to start investigating the adverse events just before FDA/EMA registration, or more commonly, afterward. Then all the material is already written and a negative statement is made: again a drug is developed with undesirable and hard to treat adverse events. A drug that no one wants to prescribe to patients because it will soon or later bring trouble in the form of adverse events and extra costs. This can be done much better!