Regulatory Resources

The following resources will help you to write regulatory-compliant SAS applications. 

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Inevitably, there will be a need to carry out a regulatory impact assessment on the resources needed to implement REACH. Not only does this have implications on ensuring a level playing field for business across the EU, it may also affect regulatory resources available for promoting international action on chemical control. 

This chapter outlines the software implementation and validation process, to an extent that the pharmacometrician could in fact establish the quality assurance infrastructure, implement the hardware and software, and validate the implementation independent of dedicated internal IT or regulatory resources. Though such an approach is not recommended, the purpose of this chapter is to give the scientist a clear understanding of what is required in order to be successful in such an endeavor. 

In summary, MRLs are derived following an assessment of incurred residues resulting from approved conditions of use and represent the maximum residue concentrations that are consistent with those label uses (e.g., dose and routes of administration). Residues in excess of the MRL are indicative of uses outside the approved conditions of use. Thus, the MRL approach is extremely effective in monitoring label compliance, focusing regulatory resources on those residue cases that represent deviations from the labeled conditions of use. However, because not all extralabel uses result in unsafe residues, the MRL approach may result in compliance cases that cannot claim to protect the public health. ... 

CTFA—Cosmetic, Toiletry and Fragrance Association, 2003, International Regulatory Resource Manual, 5th Ed., CTFA, Washington, DC. 

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