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 Corporate Compliance Program
   
 

In keeping with the Department of Health and Human Services Office of Inspector General Guidance to Pharmaceutical Manufacturers which became effective in April 2003, Solvay Pharmaceuticals, Inc. has formalized its compliance program with an approved policy and appointed a Compliance Officer.  The Compliance Officer is responsible for the establishment and maintenance of the compliance program and shares a dual reporting structure up through the Quality Assurance/Quality Compliance Division to the Chief Executive Officer, with open reporting access to all members of the U.S. executive team known as the Pharmaceutical Leadership Team (PLT).

The corporate compliance program focuses oversight on guidance-identified areas including, but not limited to, marketing and promotional practices, government pricing and contracts, drug sampling efforts and the giving of grants for scientific education and independent clinical investigation.  The company has established and/or strengthened internal policies and procedures relating to the above-listed areas, and reviews and revises them on an ongoing basis. 

The company seeks to comply with all known and evolving state-specific promotional and price reporting requirements, and strives to enforce synergy with all internally established compliance policies and practices with co-marketing partners, contractors and vendors.    

Promotional efforts with healthcare professionals and other customers are to be conducted with courtesy and professionalism, and in keeping with the regulations and laws governing those activities.   All programs, honoraria and promotional items must be officially reviewed and approved prior to participation, disbursement or use, and must be consistent with internally established parameters or policies governing fair market value and/or PhRMA guidelines (as applicable).      

A Compliance Committee comprising managerial representatives from key corporate areas such as manufacturing, research and development, quality assurance, commercial operations, human resources, legal and finance has been established, and meets regularly with the Compliance Officer to discuss matters of actual or potential compliance concern.  Significant matters are shared with the CEO and members of the PLT.

Reports of suspected misconduct or non-compliance received through internal or external sources are documented and investigated to assure prompt corrective action is employed if deemed necessary.

General and targeted training programs encompassing both lecture format and text-based components have been developed, and are conducted regularly, for both corporate and field-based employees.  These programs are conducted by experts who focus on ethics, lawful behavior, corporate values and good business practices. 

 

 

 

 

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Date of last update: 6/26/2008