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CBI's 5Th Annual Pharmaceutical Marketing Compliance Congress

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VISIT WWW.CBINET.COM FOR CONFERENCE UPDATES Industry Perspectives: CBI’s 5th Annual Ear CLE n Pe Cre nding di Minnie Baylor Henry, Vice President, App ts roval Medical and Regulatory Affairs, McNeil Consumer & Specialty Pharmaceuticals Ann Beasley Bacon, Senior Corporate Counsel, PharmaceuticalPharmaceutical Sepracor Inc. Rick Cassino, Vice President, HCC, Johnson & Johnson Pharmaceuticals Group Gordon M. Chapman, Senior Director, Asia Pacific Compliance, Bristol-Myers Squibb Company MarketingMarketing Colleen M. Craven, Vice President, Ethics and Corporate Compliance, Endo Pharmaceuticals Kris Curry, Director, HCC Operations, Ortho McNeil Janssen Kim Elting, General Counsel, ANS Medical (subsidiary of St. Jude Medical) ComplianceCompliance Margaret K. Feltz, Associate Director, Corporate Compliance, Purdue Pharma L.P. TM JANUARY 28-29, 2008 Indrani M. Franchini, Deputy Compliance Officer, Worldwide Programs, Senior Corporate Counsel, CongressCongress THE RITZ-CARLTON • WASHINGTON, DC Pfizer Inc Robert Freeman, U.S. Compliance Officer and Compliance Counsel, Serono, Inc. Premier Forum for Compliance Professionals Led by Compliance Professionals Roy Galan, Assistant Director of Sales Training, Astellas Daniel Garen, Chief Compliance Officer, Siemens Medical Solutions Diagnostics Lead Sponsor: Media Partner: Gary Giampetruzzi, Senior Corporate Counsel, Pfizer Inc Tom Glavin, Deputy Compliance Officer, Shire Jeffrey Greenman, Vice President, Compliance, Bayer Monica Jonhart, Director, Compliance and Auditing, Move Between 3 Comprehensive Conference T racks: Bristol-Myers Squibb Stephen Kanovsky, U.S. Compliance Officer, Fraud & Abuse • Medical Communication Exchange • State Laws for Sales, Marketing and Pricing sanofi-aventis Fabiana Lacerca, Legal Compliance Director, Keynote Speaker Bristol-Myers Squibb Geno Germano, Ed Miller, Chief Compliance Officer, “Industry Changes and Complexity Call for President, Boehringer Ingelheim Pharmaceuticals U.S. and General Manager, Anne Nobles, Vice President, Compliance and Reinventing the Traditional Pharmaceutical Enterprise Risk Management, Eli Lilly Company Model” Wyeth Pharmaceuticals Lori Queisser, Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation Michael Shaw, Global Head, Ethics & Compliance, Keynote Panel Discussions Novartis Oncology Jim Shehan, Vice President and General Counsel, “Perceptions Pre and Post Investigations Settled in 2007” Novo Nordisk Jon Sprole, Chief Compliance Officer, Bristol-Myers Squibb Carol Gamble, J.D., James Bianco, M.D., Jason Hanson, Senior Vice President, President and CEO, Executive Vice President Marc Stanislawczyk, Counsel, AstraZeneca Pharmaceuticals LP General Counsel and Cell Therapeutics and General Counsel, Scot Steinheiser, Assistant Director, Corporate Secretary, Medicis Pharmaceutical Corporate Compliance, Astellas Jazz Pharmaceuticals Corporation Michael P. Swiatocha, Vice President and SPRI Compliance Officer, Schering-Plough Research “Law Enforcement Panel” David Vance, J.D., Senior Director, Business Conduct, Gilead Sciences, Inc. James Stansel, Lewis Morris, Douglas F. Gansler, Stephen Cha, L. Stephan Vincze, J.D., L.L.M., MBA, Vice President, Deputy Deputy Inspector Attorney M.D., MHS, Ethics and Compliance Officer, Privacy Officer, General General General, Committee on TAP Pharmaceutical Products Inc. Counsel, and Chief Maryland Oversight and Government Officials: HHS Counsel Government to the Inspector Reform, Julie Brill, Assistant Attorney General, General, U.S. House of Office of Attorney General, Vermont OIG Representatives Brian J. Laliberte, Deputy First Assistant Attorney General, Chief Deputy Attorney General, Criminal Division, Office of Ohio Attorney General Gold Sponsor: Educational Michael Loucks, First Assistant, U.S. Attorney Sponsor: jus Thomas L. Storm, Assistant Attorney General, Director, t Add Cong ed — Wisconsin Department of Justice H ress enry man Wax Cody Wiberg, Pharm.D., R.Ph., Executive Director, man Minnesota Board of Pharmacy Outstanding Lawrence G. Wasden, Idaho Attorney General; President, Support National Association of Attorneys General Provided by: Marcia B. Wooden, Executive Director, Organized By: Board of Pharmacy and Pharmaceutical Control, District of Columbia Choose from 4 Pre-Conference Workshops — Monday, January 28, 2008 A Fundamentals of B Strategies for Effective A Primer! Marketing Compliance Compliance Training Understanding the evolving world of compliance is still a complex Training is an important aspect of compliance and needs to be issue for the industry, added to this is the ever increasing pressure of continually updated to ensure the new and changing issues are heightened government regulations and increased regulatory scrutiny. addressed without overburdening sales marketing and medical affairs This in-depth workshop provides attendees with a thorough professionals with too much training. The effectiveness of any understanding of the key areas in marketing compliance and the tools compliance program can not be audited unless the standard of behavior needed for developing an effective compliance program. has been communicated appropriately. Therefore, it is important for companies to ensure that the dollars invested in training return value in 7:30 Registration and Continental Breakfast reducing risks and ensuring compliance. In this workshop, learn how to improve compliance training and its overall value. 8:30 Workshop Leaders’Welcome and Opening Remarks 7:30 Registration and Continental Breakfast I. Implementing a Compliance Program — 8:30 Workshop Leaders’Welcome and Opening Remarks Changing Management Mindset • How to work with senior management to set I. Innovative Training Techniques appropriate expectations for compliance — • Understand what types of new training tools Help your organization change how they’ve are available done it “forever”, particularly if they feel they’ve • Develop the right mix of online and been successful live interactive training II. Effective Internal Communication for Successful II. Verify Compliance Training Programs Are Compliance Program Development Having a Positive Impact • Resources for questions and guidance • Highlight positive compliance practices • Developing opportunities for dialogue * do you incentivize field professionals to complete within departments required training — pros and cons • Compliance contributing to the bottom line — III. Monitoring and Assessment How do we move from minimally required training to • Assess effectiveness of training to promote effective training compliance • Test the effectiveness and value of compliance training • Establish an effective monitoring program • Conducting ongoing analysis • Document and investigate any findings III. Partnering for Success IV. Compliance Program Development • Utilize in-house corporate training departments • Tailoring compliance programs to fit specific needs • When to outsource training • Incorporating flexibility to respond to change • What to look for in a training partner 12:00 Close of Workshop A 12:00 Close of Workshop B There will be a 30-minute networking and refreshment break at 10:00 a.m. There will be a 30-minute networking and refreshment break at 10:00 a.m. — WORKSHOP LEADERS — — W ORKSHOP LEADERS — Robert Merrill, J.D., Kip Ebel, Scot Steinheiser, Roy Galan, Senior Manager, Senior Manager, Assistant Director, Assistant Director of Sales Training, Ernst & Young Ernst & Young Corporate Compliance, Astellas Astellas 8:30-12:00 INVITATION-ONLY CHIEF COMPLIANCE OFFICER SUMMIT: CBI is proud to announce the 4th Annual Invitation-Only Chief Compliance HOSTED BY: Officer Summit, to be held Monday morning, January 28, 2008 in Washington, DC, in conjunction with the 5th Annual Pharmaceutical Marketing Compliance Congress. Because we recognize the complex role of the Chief Compliance Officer in this changing economic, political and regulatory climate, CBI has created a forum to convene those in this critical role to openly discuss their challenges, both present and future. If you would like to be a part of this exclusive forum, please contact Roberts Apse at 781-939- 2 2590 or [email protected] for complete information and a separate agenda. Choose from 4 Pre-Conference Workshops — Monday, January 28, 2008 C Tools to Conduct an D Ensuring Compliance in Effective Risk Assessment Clinical Research The need to conduct periodic assessments to measure the effectiveness Companies are continuing to see sales and marketing activities of the compliance function remains a key focus area for most scrutinized by the government and public. However, the next pharmaceutical and medical device companies. The effectiveness of area that is now receiving focused attention is in clinical monitoring and auditing controls used by the compliance and ethics function is underscored by numerous regulatory enforcement agencies, research. Given the heightened level of oversight, it has become the U.S. Sentencing Guidelines (§8B2.1) and for publicly traded a necessity for companies to ensure that they are remaining in companies Section 404 of the Sarbanes-Oxley Act. Attendees of this compliance with their clinical and post-marketing studies. workshop obtain the tools to conduct an effective risk assessment and This workshop addresses the current climate for clinical and strategies to use those tools to measure risk in three key areas of post-marketing studies and how to ensure programs and company operations: sales & marketing, commercial contracting
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