DRAFT Challenges Of Managing A Global Compliance Effort Presentation To First International Medical Device Compliance Congress May 27, 2008 Kristine Rapp,

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Presentation transcript:

DRAFT Challenges Of Managing A Global Compliance Effort Presentation To First International Medical Device Compliance Congress May 27, 2008 Kristine Rapp, Vice President, Global Ethics and Compliance, Hospira, Inc. Paul E. Kalb, Chair, Health Care Group, Sidley Austin LLP

Overview Understanding Requirements and Needs Setting Priorities DRAFT Overview Understanding Requirements and Needs Setting Priorities Assuring Effectiveness

Understanding Requirements And Needs DRAFT Understanding Requirements And Needs Local Laws Industry Codes Gap Analysis Reconciling Divergent Requirements Establish uniform rules? Rationalize different rules?

Setting Priorities Enterprise Risk Management DRAFT Setting Priorities Enterprise Risk Management Reactive vs. Proactive Approaches Communicating Expectations Leveraging Compliance Resources

Assuring Effectiveness DRAFT Assuring Effectiveness Monitoring and Auditing Local restrictions on standard Monitoring /auditing techniques Protecting the Attorney-Client Privilege Disciplinary Action Local HR restrictions Systemic Feedback

DRAFT END