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Steve Mohr, Esq. Deputy Compliance Officer AstraZeneca Pre-Conference Co-Chair

Current Issues in Pharmaceutical and Medical Device Compliance Management Introductory Comments Pharma, Medical Device & Biotech Colloquium June 6, 2005. Steve Mohr, Esq. Deputy Compliance Officer AstraZeneca Pre-Conference Co-Chair. Overview

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Steve Mohr, Esq. Deputy Compliance Officer AstraZeneca Pre-Conference Co-Chair

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  1. Current Issues in Pharmaceutical and Medical Device Compliance ManagementIntroductory CommentsPharma, Medical Device & Biotech ColloquiumJune 6, 2005 Steve Mohr, Esq. Deputy Compliance Officer AstraZeneca Pre-Conference Co-Chair

  2. Overview • The Evolving Role of Compliance in the Pharma and Device Industries • New Challenges • Revised Sentencing Commission Guidelines • Scrutiny Beyond Sales and Marketing Activities • State Laws and Enforcement • Today’s Goals • Today’s Agenda

  3. Evolving Role of Compliance • Ten years ago, regulatory compliance was focused on FDA issues and was addressed through existing functions (Legal, Finance, etc.) • Today, compliance is addressing multiple regulatory issues at the federal, state and international levels, and is emerging as a separate function and discipline • As compliance programs expand, and scrutiny intensifies, some companies are moving toward a “regulatory risk management” approach

  4. New USSC Guidelines • Recent amendments (effective November 1, 2004) strengthened each of the seven elements (and arguably added a new element) • Amendments include important changes (partial list): • Compliance programs should be designed to reasonably prevent and detect all violations of law (not just crimes) • Significantly expands responsibility of “governing authority,” including a requirement to “otherwise promote an organizational culture that encourages ethical conduct and a commitment to compliance …” (emphasis added) • Requires adequate resources to implement the program • Requires periodic evaluation of program effectiveness • The amendments reflect – and in some instances go beyond – the suggestions in the HHS OIG Guidance

  5. Going Beyond Sales & Marketing • Legal and regulatory scrutiny – which has focused to date largely on sales and marketing areas – is moving into new areas. • These areas include: • Clinical research • Adverse event reporting and drug safety • GMP • International • Management in many companies is looking to the Compliance Department to leverage existing resources (e.g., web-based training platforms, Compliance Helpline, etc.) to address these areas

  6. State Law Compliance • Proliferation of state laws targeting pharma/device marketing and promotion is a relatively new challenge • Six states currently have laws on the books • California • Maine • Minnesota • Vermont • Washington, DC • West Virginia • Legislation pending in more than a dozen other states • These laws are particularly challenging due to slight differences in approach and requirements

  7. Today’s Goals • Our goal is to discuss and provide practical tips and insight on some of the toughest challenges facing compliance professionals in the pharmaceutical and medical device industries • We hope to touch on the issues that you can’t look up • How to engage Senior Management in compliance issues • How to motivate employees (and keep them motivated) on compliance issues • How to tackle multiple issues with limited resources

  8. Today’s Agenda • First panel: Primer on Compliance Program Issues for Pharma and Device Companies • Second Panel: Discussion of Key Risk Areas for Pharma and Device Companies • Third Panel: Roundtable Discussion of Ten of the Toughest Challenges Facing Pharma and Device Compliance Professionals

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