Regulatory management

Harmonization of Environmental Chemistry and Fate Data Requirements Under NAFTA, Regulatory Proposal PRO 2001-02, Health Canada, Pesticide Regulatory Management Agency. Also available on the World Wide Web http //www.hc-sc.gc.ca/pmra-arla/english/pdf/pro/pro2001-02-e.pdf. 

New Drug Approval Process Clinical and Regulatory Management,... 

Documented personal communication from regulatory managers of a consumer product manufacturer and an electronics manufacturer in January 2006. 

Regulatory Letter (FDA postaudit letter) Regulatory Management Officer... 

Millstein, L. G., Specific Requirements, Content, and Format of an NDA, New Drug Approval Process Clinical and Regulatory Management, R.A. Guarino (ed.)(New York, NY Marcel Dekker, Inc., 1987). 

This book features regulatory management, sediment transport processes, chemical and biological processes, process synthesis, and modeling techniques. Contents include partitioning of toxic metais, reactions of trace elements, and partitioning of organic chemicals. 

Regulatory management is a three-step process. First, it is essential to understand the statutory requirements and the purpose of any applicable federal and state regulations. Second, one must develop the data base and scientific rationale necessary to demonstrate the safety of a product within the regulatory framework. Finally, one must have a proactive outreach program for dealing with public concerns. 

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