1 / 8

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

dafydd
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related