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Because of the complexities involved in assuring compliance and the importance of this function to the economic aspects of a company, it is not surprising to find more and more legally trained persons gravitating to this area. We have already noted that compliance in some areas, such as equal employment opportunity compliance assigned to the Employee Relations function, is allocated on the basis of the involvement of the operating unit. In some companies, however, all regulatory compliance matters are supervised from a central unit.
It would be impossible to list in this brief publication all of the types of activities which may be carried on under the general designation of "regulatory compliance." However, a partial listing of the functions performed in a single company involved in the production of drugs, cosmetics and devices in meeting the requirements of the Food and Drug Administration, the U.S. Department of Agriculture and the Federal Trade Commission concerned with these areas of production will give you some idea of the nature of the work.
- Coordinates and supervises all the activities involved in the preparation of technical data for submission to government agencies such as the FDA, USDA and FTC.
- Gathers, organizes, prepares, assembles and submits information for Investigational New Drug submissions and New Drug Applications in accordance with new drug regulations, reviewing them for completeness and accuracy.
- Negotiates with the FDA with regard to product claims and coordinates contacts for the company and FDA scientific review personnel.
- Serves as the company representative during plant inspections by FDA personnel.
- Coordinates training sessions for manufacturing and control personnel under simulated FDA inspection conditions.
- Reviews and approves labeling, advertising and specifications to assure compliance with FDA regulations.
- Coordinates the preparation and submits periodic reports including literature surveys required by government agencies when marketing new drugs.
- Assembles and summarizes data in response to specific trade associations or government agency requests for data.
- Acts as liaison in coordinating activities between the company and government agencies by acquiring information on new guidelines, regulations and amendments.
- Summarizes regulatory information to be supplied to other operating units and companies.
Another area of activity is that of the collection, reading, commenting, analyzing, preparation of summaries of, and training others in compliance with, governmental regulations. Legal training is useful, also, and frequently employed, in the formulation of plans and procedures for compliance. They are apt better to understand regulations than laymen and to determine whether contemplated procedures will accomplish necessary results.
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