chandDeviceColloq课件.pptVIP

The Pharma, Biotech and Device ColloquiumJune 7, 2004“Building the Compliance Program of the Future and its Role in Business Strategy” Enhancing Reputation Lori Queisser, Lilly Risk Management Bert Weinstein, Purdue Measuring Effectiveness Stephan Vincze, TAP Challenges of Biotechs Liz Lewis, Millennium Challenges of Devices Link Bonforte, ConvaTec Program of the Future Charles Brock, Abbott Moderator Douglas Lankler, Pfizer “The views expressed by the panelists are their own and do not represent those of their companies.” “The Role of a Company’s Compliance Program in Enhancing the Reputation of the Enterprise.” Lori Queisser Vice President, Chief Compliance Officer Eli Lilly and Company Would you take medicine manufactured by Enron if they were in the pharma business? Reputation is increasingly a differentiator Shareholder Payer Prescriber Consumer Reputation is measured in the court of public opinion AP/UPI help serve as reminder of who’s good and who’s bad Link of Reputation to Compliance Programs Compliance programs foster good compliance Good Compliance leads to reliability Cumulative experiences lead to a company’s reputation Keys to Successful Linkages Compliance must be integrated into business to be leveraged Cannot exist in silos Video must match audio Iterative – not point in time Must be risk based The Pharma, Biotech and Device Colloquium June 7, 2004 “The Role of a Company’s Compliance Program in Implementing a Program of Enterprise Risk Management” Genesis of Internal Control Requirements Catalysts for change in corporate governance Securities and Exchange Acts, 1933-1934 Foreign Corrupt Practices Act, 1977 Treadway Commission, 1987 US Federal Sentencing Guidelines False Claims Act Cases Sarbanes-Oxley, 2002 Most of this legislation or guidance resulted from periodic public concern over illegal or unethical activities of certain corporations and the lack of transparency in financial reporting. Treadway Commission – 1987COSO – Gene