Regulator’s risk

Thus, according to this argument, there is no need to use a two-sided test, since in the unlikely event of the drug s having a harmful effect the regulator s risk will be less than 0.05 anyway. 

Regulator s risk. The probability of registering a drug given that it is, in fact, either useless or worse than useless. 

Medicines, Research, Regulation and Risk The Queen s University of Belfast Press, 1st edn 1989, 2nd edn 1992. 

What, then, is the impact or wider political role of SCHER Has it in any discemable way shaped the Commission s risk regulation policies Generally speaking, our study has indicated that SCHER achieves what it is primarily supposed to do - that is, reviewing the scientific quality of risk assessments. By its very nature, it is difficult to say anything conclusive about what kind of policy impact this entails. More often than not, SCHER s opinions grant a lot of leeway to the Commission, particularly in those many cases when data on risks is either unavailable or plagued with severe uncertainties. In those cases, the impact of SCHER has often been a call for more and better data, which has not in any clear way translated into policy. 

In Medicines, Regulation and Risk, 2nd. edition, JP Griffin ed., p. 287-302 The Queen s University of Belfast, 1992... 

A further challenge to an empirical investigation of the role of OELs in enforcement is that the present structure of Labour Inspectorate databases means that a comprehensive analysis of enforcement activity, in as far as it addresses efforts to regulate chemical risk management and the inspectorate s use of OELs in this respect is not possible. Therefore some indicative results of local investigations undertaken expressly for this study are presented to supplement the rather meagre evidence that can be gained from examination of national data. 

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