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PCC 2014 – 11th Annual Pharmaceutical Compliance Congress
 

PCC 2014 – 11th Annual Pharmaceutical Compliance Congress

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    PCC 2014 – 11th Annual Pharmaceutical Compliance Congress PCC 2014 – 11th Annual Pharmaceutical Compliance Congress Document Transcript

    • PCC 2014 JANUARY 28-29, 2014 • THE RITZ-CARLTON • WASHINGTON, DC 11 TH John Crisan Chief Compliance Officer Johnson & Johnson Cynthia “Cindy” Cetani Vice President, Ethics and Compliance and Chief Compliance Officer Novartis Pharmaceuticals Corporation Jeffrey E. Fleming Vice President Compliance North America AstraZeneca Thomas W. Abrams, R.Ph., MBA Director Office of Prescription Drug Promotion, FDA Ilisa B.G. Bernstein, PharmD., J.D., Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration U.S. Attorney Paul J. Fishman, U.S. Attorney’s Office for the District of New Jersey Zane David Memeger, Esq. U.S. Attorney U.S. Attorney’s Office for the Eastern District of Pennsylvania The Honorable William C. Killian, U.S. Attorney, U.S. Attorney’s Office for the Eastern District of Tennessee Samuele Butera Vice President and Head Biopharmaceuticals, Sandoz North America, Sandoz Elizabeth V. Jobes, Senior Vice President, Chief Compliance Officer Auxilium Carmen Ortiz U.S. Attorney U.S. Attorney’s Office for the Eastern District of Massachusetts Michael Parini, Senior Vice President, Chief Litigation Counsel Pfizer Inc 90+ Industry Experts Platinum Foundation Sponsor 50+ Sessions 1 Choice for Compliance CCO Summit Host COMPLIANCE CONSULTING LEADERS CIRCLE LEGAL LEADERS CIRCLE Bronze Sponsor Bronze Sponsor Associate Sponsors www.cbinet.com/pcc
    • Agenda at a Glance Day One — Tuesday, January 28, 2014 Day One 7:00 Main Conference Registration and Continental Breakfast 8:00 Day One Chairman’s Welcome and Opening Remarks 1 THE BASICS IN HCC AND POLICY APPLICATIONS 8:05 Platinum Foundation Sponsor’s Welcome and Opening Remarks 2 PRODUCT PROMOTIONAL COMPLIANCE 3 GLOBAL TRANSPARENCY OF HCP SPEND 4 COMPLIANCE CONSIDERATIONS FOR CLINICAL RESEARCH AND PRE-APPROVAL COMMUNICATIONS 8:15 TRACKS CMS ADDRESS Review of Open Payments FDA/OPDP ADDRESS 8:45 9:15 9:45 An Update on Promotional Guidance, Enforcement and Oversight Trends from the OPDP U.S. ATTORNEY’S OFFICE ADDRESS Enforcement Perspective — 2014 High Priority Areas Day One WORKSHOPS ENFORCEMENT PANEL U.S. Healthcare Fraud Enforcement — Trends and Top Priorities THE ROLE OF COMPLIANCE IN GMP B SPECIALTY PRODUCTS — UNIQUE COMPLIANCE CHALLENGES FOR HIGH-COST PRODUCTS AND THE HIGH-TOUCH SERVICES USED FOR PROMOTION AND MARKETING C FCPA — KEY INSIGHTS AND ENFORCEMENT TRENDS D UTILIZING COMPLIANCE MONITORING DATA TO INFORM BUSINESS PRACTICES E EFFECTIVE CRISIS MANAGEMENT FOR COMPLIANCE — TAKE PREPARATION TO A DIFFERENT LEVEL F 10:25 A ENGAGE THE ORGANIZATION — EFFECTIVE COMPLIANCE TRAINING TACTICS AND TECHNIQUES G CONSIDERATIONS DURING INVESTIGATIONS AND AUDITS — WHAT ARE WE MISSING? DEFENSE PANEL A View from the Outside Counsel — Prepare for the Future 11:00 Networking and Refreshment Break 11:30 CHOOSE FROM FOUR COMPREHENSIVE TRACKS (1-4) 1:40 Networking Luncheon 1:40 INVITATION-ONLY CHIEF COMPLIANCE OFFICER SUMMIT 2:40 CHOOSE BETWEEN FOUR CONCURRENT WORKSHOPS (A-D) 4:10 Networking and Refreshment Break 4:40 CHOOSE BETWEEN THREE CONCURRENT WORKSHOPS (E-G) 6:10 Close of Day One 6:10 Networking, Wine and Cheese Reception
    • PCC 2014 Day Two — Wednesday, January 29, 2014 7:00 8:00 Day Two Chairperson’s Welcome and Opening Remarks Day Two Main Conference Registration and Continental Breakfast 8:15 9:00 TRACKS 5 FDA/CDER ADDRESS Top Priorities for Oversight at FDA 6 Making Compliance Part of Management 101 7 CCO PANEL 10:00 Compliance as a True Business Partner — Achieve an Internal Compliance Culture Working with the Business GLOBAL ABAC AND INTERNATIONAL COMPLIANCE STRATEGIES OFF-LABEL RISKS AND CONTROLS COMPLIANCE PROGRAM STRUCTURE AND EFFECTIVENESS FIELD FORCE OVERSIGHT 9 11:00 8 SUNSHINE AND OPEN Networking and Refreshment Break 11:30 CHOOSE BETWEEN FIVE COMPREHENSIVE TRACKS (5-9) 1:35 Networking Luncheon 2:35 CHOOSE BETWEEN FIVE INTERACTIVE DISCUSSIONS (A-E) 4:10 Close of Congress PAYMENTS COMPLIANCE Day Two INTERACTIVE DISCUSSIONS B COMPLIANCE CONSIDERATIONS FOR SMALL TO MID-SIZED COMPANIES C www.cbinet.com/pcc A RE-THINKING HOW YOU CONDUCT A RISK ASSESSMENT OVERLAP OF COMPLIANCE ACTIVITIES AND RESPONSIBILITIES BETWEEN GENERIC AND BRANDED DIVISIONS WITHIN COMPANIES D CODE OF CONDUCT TRAINING, COMMUNICATION AND INTEGRATION E THE AFFORDABLE CARE ACT AND HEALTHCARE REFORM ON COMPLIANCE
    • Featured Government & Industry Speakers Thomas W. Abrams, R.Ph., MBA, Director, Office of Prescription Drug Promotion, FDA Peter Agnoletto, CPA, Senior Director, North America Compliance Team, Sanofi US Matthew Allegrucci, General Counsel, Chief Compliance Officer, Daiichi Sankyo Dennis K. Barnes, Esq., CPA, Senior Director, North America Compliance, Sanofi US Victoria Browning, Senior Director, Corporate Compliance Operations, Allergan Samuele Butera, Vice President and Head Biopharmaceuticals, Sandoz North America, Sandoz Cynthia “Cindy” Cetani, Vice President, Ethics and Compliance and Chief Compliance Officer, Novartis Pharmaceuticals Michael Clarke, Vice President, Ethics & ComplianceAmericas, Actavis Inc. Sanford C. Coates, U.S. Attorney, U.S. Attorney’s Office for the Western District of Oklahoma Arthur J. Corrado, Compliance Officer – Pharmaceuticals, Endo Health Solutions Inc. Eve Costopoulos, Vice President, Chief Ethics and Compliance/Internal Audit, Eisai Matthew D’Ambrosio, Senior Vice President and Chief Compliance Officer, Sunovion Pharmaceuticals Inc. Howard L. Dorfman, Vice President, General Counsel, Ferring Pharmaceuticals Inc. Bob Doyle, Executive Director, Commercial Compliance, Boehringer Ingelheim Daniel Dunham, Vice President, Chief Compliance Officer, Aptalis Pharma US Inc. Erik Eglite, Vice President, Chief Compliance Officer and Corporate Counsel, Lundbeck Pharmaceuticals Richard F. Eschle, Pharm.D., JD, Senior Director, Corporate Ethics and Compliance, Eisai Inc. Christine Fiore, Compliance Business Partner, Boehringer Ingelheim Jeffrey E. Fleming, Vice President Compliance North America, AstraZeneca Patrik Florencio, Vice President and Chief Corporate Compliance Officer, Sandoz North America, Sandoz Gary Giampetruzzi, Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc Timothy Grimes, Health Care Compliance Officer, Johnson & Johnson Cynthia Ham, US General Counsel and Chief Compliance Officer, ProStrakan, Inc. Samantha Hand, Training Manager, JJHCC&P, Johnson & Johnson Jim Heintzelman, Deputy Compliance Officer, Endo Health Solutions Inc. Elizabeth V. Jobes, Senior Vice President, Chief Compliance Officer, Auxilium The Honorable William C. Killian, U.S. Attorney, U.S. Attorney’s Office for the Eastern District of Tennessee Beth F. Levine, Vice President, Assistant General Counsel & Chief Compliance Officer, Regeneron Pharmaceuticals, Inc. Geoff Levitt, Chief Regulatory Counsel, Pfizer Inc Zane David Memeger, Esq., U.S. Attorney, U.S. Attorney’s Office for the Eastern District of Pennsylvania Bill Nettles, U.S. Attorney, U.S. Attorney’s Office for the District of South Carolina Ed Nowicki, Vice President and Assistant General Counsel, Pfizer Inc Carmen Ortiz, U.S. Attorney, U.S Attorney’s Office for the District of Massachusetts Gus Papandrikos, Director, Compliance, Daiichi Sankyo Michael Parini, Senior Vice President, Chief Litigation Counsel, Pfizer Inc Erin Parsons, Health Care Compliance Director, Medical and Scientific Affairs, Johnson & Johnson www.cbinet.com/pcc Sheetal Patel, Pharm.D., Regulatory Compliance Lead, U.S. Pharmaceuticals Group HCC, Johnson & Johnson Greg Pellicano, Vice President, Deputy Compliance Officer, Shire Jonathan Provoost, General Counsel, Chief Compliance Officer, Ikaria Erik Ramanathan, Senior Fellow, Harvard Law School Program on the Legal Profession, Harvard Law School Mike Rivas, Director, US Ethics and Compliance, Novartis Oncology Lynn Robson, Executive Director Legal, Chief Compliance Officer, Leo Pharma Jeffrey Rosenbaum, Vice President, Chief Compliance Officer, Vertex Pharmaceuticals Paul Savidge, Senior Vice President, Deputy General Counsel, Global Commercial and R&D, Bristol-Myers Squibb Sue Seferian, Health Care Compliance Officer, Johnson & Johnson Daina Selvig, Director, Corporate Compliance, Ironwood Pharmaceuticals Howard Sklamberg, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA (Invited) Jon Smollen, Executive Vice President, Corporate Compliance, Endo Health Solutions Inc. David Stollman, Chief Compliance Officer, Incyte Dinesh S. Thakur, Plaintiff/Relator, US ex. rel. Thakur Vs. Ranbaxy Laboratories Limited David Vance, Senior Director, Compliance Counsel, Noven Pharmaceutical Inc Sarah Whipple, Vice President, Chief Compliance Officer, Aegerion Pharmaceuticals Angela Wood, Health Care Compliance Officer, Johnson & Johnson
    • Main Conference Day One — Tuesday, January 28, 2014 7:00 Main Conference Registration and Continental Breakfast and prosecutions, as well as the deterrent effect of prosecutions relating to the pharmaceutical employees, physicians and HCPs. 8:00 Day One Chairman’s Welcome and Opening Remarks John Crisan, Chief Compliance Officer, Johnson & Johnson 8:05 Platinum Foundation Sponsor’s Welcome and Opening Remarks Ted Acosta, J.D., Principal, Fraud Investigation & Dispute Services, Ernst & Young 8:15 CMS ADDRESS Review of Open Payments • Gain insight from CMS’ experience during the first round of reporting • Review concerns and obtain clarity on frequently asked questions * Clarify reporting of payments to physicians for promotional speaking * Report the value of journal reprints * Assess CMS stance on promotional speaking payments * Understand resubmissions with corrections or updates Carmen M. Ortiz, U.S. Attorney, U.S. Attorney’s Office for the District of Massachusetts 9:45 U.S. Healthcare Fraud Enforcement — Trends and Top Priorities Settlements and investigations involving pharmaceutical companies for kickback and pricing violations, off-label marketing, manufacturing processes and labeling continue to make headlines. In this Government Enforcement Panel, hear directly from those involved in recent settlements and on-going investigations. • Review emerging areas of focus • Analyze recent trends in enforcement • Learn top priorities from the Department of Justice Kathleen Meriwether, Principal, Fraud Investigation & Dispute Services, Ernst & Young LLP PANELISTS: Z  ane David Memeger, Esq., U.S. Attorney, U.S. Attorney’s Office for the Eastern District of Pennsylvania Bill Nettles, U.S. Attorney, U.S. Attorney’s Office for the District of South Caroli na FDA/OPDP ADDRESS An Update on Promotional Guidance, Enforcement and Oversight Trends from the OPDP • Gain insight into the current priorities at the FDA’s Office of Prescription Drug Promotion • Review recent work on guidance development and oversight • Benefit from an assessment of current enforcement efforts through recent warning and untitled letters • Evaluate recent enforcement trends and areas of focus for OPDP Sanford C. Coates, U.S. Attorney, U.S. Attorney’s Office for the Western District of Oklahoma The Honorable William C. Killian, U.S. Attorney, U.S. Attorney’s Office for the Eastern District of Tennessee Thomas W. Abrams, R.Ph., MBA, Director, Office of Prescription Drug Promotion, FDA 9:15 Rebecca C. Martin, Deputy Chief, Civil Frauds Unit, Healthcare Fraud Coordinator, United States Attorney’s Office, Southern District of New York U.S. ATTORNEY’S OFFICE ADDRESS Enforcement Perspective — 2014 High Priority Areas In this Keynote Address, hear directly from a U.S. Attorney regarding the major trends in the healthcare arena post major settlements involving pharmaceutical companies. Benefit from a discussion surrounding recent cases and the benefits of meaningful compliance, corporate cooperation in individual investigations A View from the Outside — Mitigate Risk and Prepare for the Future Relationships with outside counsel and legal consultants in day-to-day activities are crucial for preparation, knowledge exchange and effective compliance team training and structure. During this panel, hear directly from some of the best outside counsel in the industry as a follow up to the Enforcement Panel. • Prepare for and prevent future government investigation * analyze trends to identify areas of high risk * address investigations involving multiple government agencies • Review best practices for thorough risk assessment and documentation to identify and address potential issues • Learn how outside counsel are responding to the top priorities of government agencies MODERATOR: Michael Parini, Senior Vice President, Chief Litigation Counsel, Pfizer Inc MODERATOR:  Anita Griner, MBA, PMP, Acting Director, Data Sharing & Partnership Group, CMS Center for Program Integrity 8:45 ENFORCEMENT PANEL 10:25 DEFENSE PANEL Benjamin D. Singer, Deputy Chief, U.S. Department of Justice Criminal Division, Fraud Section PANELISTS: Scott Liebman, Principal, Porzio, Bromberg & Newman P.C. Brandt Leibe, Partner, King and Spalding LLP 11:00  Networking and Refreshment Break “The conference provides a unique learning environment and opportunity for idea sharing between professionals from Industry and the government.” — Chip Franz, Healthcare Compliance Officer, Johnson & Johnson www.cbinet.com/pcc
    • Day One 11:30 Choose from 4 Comprehensive Tracks (1-4) 11:30 Track Chair’s Opening Remarks Jennifer Rhodes, General Counsel, Chief Compliance Officer and Corporate Secretary, Medivation 11:35 The Role of Compliance within the Business This two-hour track is designed for those new to compliance 1 THE BASICS IN HCC & POLICY APPLICATIONS or the pharmaceutical industry and provides participants foundational knowledge in healthcare compliance basics. I. Core Components Driving Pharmaceutical Compliance Programs • Explore compliance topics to address current laws, regulations, guidances, government settlements and other driving factors shaping compliance programs II. Moving Compliance into Operational Aspects of the Business • Discuss how these components drive internal operations from compliance departments and beyond III. Real-World Insights and Application • Apply practical learning through scenarios and benchmarking activities • Decision making exercises • Gain five unique, industry perspectives into the IV. Seven Elements of a Successful Compliance Program V. Sustainable Compliance across Departments • Embrace a compliance program across an organization • Review the importance of working with the business VI. Key Considerations for Promotional Compliance Programs • Fundamentals for promotional compliance for pre-approved and approved • Review the importance of promotional review committees Lynn Robson, Executive Director, Legal, Chief Compliance Officer, Leo Pharma Victoria Browning, Senior Director, Corporate Compliance Operations, Allergan Jennifer Sanfilippo, Senior Director, Global Contracting and Business Ethics, The Medicines Company Vera Murphy, Senior Compliance Manager, Sanofi US fundamentals of successful compliance programs • earn from recent OPDP enforcements to L enhance digital and social media compliance • mprove understanding of compliance considerations for I social and digital campaigns • nhance communication between compliance E • Understand the multiple uses of social media for pharma * marketing * clinical trial recruitment * patient engagement Jennifer Chillas, Senior Counsel, U.S. Pharmaceuticals, Bristol-Myers Squibb and marketing David Vance, Senior Director, Compliance Counsel, Noven Pharmaceutical Inc Sheetal Patel, PharmD, Regulatory Compliance Lead, U.S. Pharmaceuticals Group HCC, Johnson & Johnson 12:15 Compliant Social Interactions and Engagement • Discuss the evolving nature of prescription drugs 12:55 Communication Strategies during the Pre-Approval Period for Emerging Clinical Trials • The distinctions between off-label promotion and appropriate exchange of accurate and balanced scientific information • FDA guidance documents relating to dissemination of reprints and the difference between solicited and unsolicited requests affecting industry practice • Developing a compliant process for engaging in appropriate scientific exchange relating to clinical trials during the pre-approval period • Balancing FDA and SEC policies during the clinical trial phase • Off-label and regulatory, compliance and liability exposure on social media marketing • Analyze compliance considerations caused by the increasing role of social media and technology Howard L. Dorfman, Vice President, General Counsel, Ferring Pharmaceuticals Inc. 2 PRODUCT PROMOTIONAL COMPLIANCE 11:35 Lessons Learned from Recent Enforcement Actions Related to Digital Marketing and Social Media “This CBI conference provided an excellent format to l — Samantha Hand, Manager, Training Risk Mitig
    • Day One 11:30 Choose from 4 Comprehensive Tracks (1-4) 11:30 Track Chair’s Opening Remarks 3 GLOBAL TRANSPARENCY OF HCP SPEND Jeffrey Rosenbaum, Vice President, Chief Compliance Officer, Vertex Pharmaceuticals 11:35 Update on International Transparency Laws and Application Strategies • Discuss best practices for dispute resolution • Analyze country specific laws and how you can you apply them • Assess different processes to prepare for global transparency laws • Risk-based plan on highest level of risk within countries Susan V. Souder, Psy.D.,GMD Operations, Sr. Director, Science Unit Transparency & Reporting (SUTAR), AstraZeneca 11:30 Track Chair’s Opening Remarks Dennis K. Barnes, Esq., CPA, Senior Director, North America Compliance, Sanofi US Global HCP Contracting and Data Collection • iscuss best practices for deploying a global process D and system • Address challenges associated with standardizing strategies across geographies • Assess deployment methodologies — Pilot, region vs. global, language/currency considerations • Review technical and privacy considerations Mark Eigner, Partner, Polaris Management Partners 12:55 The Dynamic Shift - Implementing Disparate Country by Country Compliance Solutions to a Single Global 2 Local (G2L) Approach • earn how to develop and implement a single, global and robust L USA to the Rest Of the World G2L compliance, transparency and regulatory solution • nderstand from real examples how EMEA countries are coU operating cross border • ain an understanding on the corporate IT integration and critical G data needed to develop and implement a G2L solution Francis Geysermans, CTO, BMI SYSTEM 12:15 Compliance Considerations for R&D Collaborations • Understand the risks and benefits of R&D collaborations • Hear examples of R&D collaborations • Manage the risks with proper controls, communications and mitigation plans 11:35 Compliance Implications Surrounding Outsourced Clinical Trials Yolanda Lyle, • Review responsibilities for oversight of CROs Research and Development/Medical, Pfizer Inc • Understand transparency requirements around clinical trials • Analyze Sunshine regulations regarding clinical payments to HCPs • Discuss operational considerations and risk assessments of largely outsourced trials Assistant General Counsel, Chief Compliance Counsel, Christina Hwang, Senior Corporate Counsel, Pfizer Inc 12:55 Clinical Data Analysis for Dispute Resolution and Compliance Tracking • Review best practices for reporting compliance and Sue Seferian, Health Care Compliance Officer, Johnson & Johnson data integrity issues • Use of data to characterize risks in compliance GAPS • Understand the importance of written research agreements Eileen Erdos, Principal, Fraud Investigation and Dispute Services, Ernst & Young LLP • Learn strategies for remediation after GAPS are identified Colleen Hittle, Managing Director, Navigant 4 COMPLIANCE CONSIDERATIONS FOR CLINICAL RESEARCH AND PRE-APPROVAL COMMUNICATIONS Dana Thomas Director, Account Management, Science Unit Transparency & Reporting (SUTAR), AstraZeneca 12:15 1:40  Networking Luncheon and Invitation-Only CCO Summit learn as well as build relationships across the industry.” gation and CIA Management, Johnson & Johnson
    • Chief Compliance Officer Summit This Summit is designed to encourage an open exchange of ideas and strategies surrounding some of the most critical issues facing Chief Compliance Officers, their programs and teams across the life sciences industry. Facilitators lead discussions surrounding common questions, challenges and issues facing CCOs today. Participants benefit from exclusive networking with peers in similar positions, share challenges and pose questions of their colleagues to come away with valuable insight into current and future compliance initiatives. An antitrust attorney is present throughout the Summit to ensure appropriate and compliant discussion among participants. *Invited participants hold the title of Chief Compliance Officer, Vice President of Compliance, General Counsel or an equivalent compliance leadership position at a life sciences company (at the time of the conference). Final eligibility approval is at the discretion of CBI. www.cbinet.com/pcc 1:40 Summit Host Welcome and Antitrust Guideline Reminders D. Jeffrey Campbell, Principal, Porzio, Bromberg & Newman P.C. 1:50 Effective Board and Audit Committee Interactions Jeffrey E. Fleming, Vice President Compliance North America, AstraZeneca 2:30 Explore the Role of the CCO in GMP Compliance Brian Beeler, HOSTED BY   Vice President, Chief Compliance Officer, Associate General Counsel, Horizon Pharma 3:10 ABOUT OUR SUMMIT HOST Porzio, Bromberg & Newman P.C. (“Porzio”) was founded in 1962 as a three-attorney firm and has grown to its present size of over 90 attorneys and 50 paraprofessionals with three office locations. Porzio has served the life science industry for over 30 years and has developed an expertise in the area of marketing and sales compliance consulting services for life science companies. Porzio develops compliance programs and conducts risk assessments and audits. Porzio drafts codes of conduct, policies, and procedures and develops and conducts training programs for life science clients. It also provides counseling on a broad spectrum of compliance and regulatory issues for life science companies. Porzio has also provided life sciences product liability defense services in excess of 10,000 cases, and over 100,000 cases in other industries. Due to this vast product liability experience, Porzio additionally provides risk assessments associated with life science marketing products. In 2004, Porzio formed Porzio Life Sciences, LLC (“PorzioLS”) to provide the life science industry with Internetbased products enabling companies to comply with state laws and regulations on marketing and sales, as well as, distribution, licensing, sampling and a growing body of state pharmaceutical compliance requirements. PorzioLS provides compliance tools and services, such as Porzio Compliance Digest (PCD) and Porzio AggregateSpendID, that enable companies to comply with federal and state marketing and sales regulations. PorzioLS has evolved into an industry leader in life science marketing and sales compliance. Together, the companies provide regulatory compliance and legal services related to the Prescription Drug Marketing Act (PDMA), anti-kickback statutes, False Claims Act, state and federal aggregate spend laws and regulations, FDA regulations, and OIG and CMS guidances. The Role of CCOs Jonathan Provoost, General Counsel, Chief Compliance Officer, Ikaria 3:50 Networking and Refreshment Break 4:20 Implement Thorough Risk Assessments Across an Organization Roger Louis, Senior Vice President, Compliance and Risk Management, Chief Compliance Officer, Cubist Pharmaceuticals 5:00 Investigations, Monitoring and Audits Eve Costopoulos, Vice President, Chief Ethics and Compliance/Internal Audit, Eisai 5:40 Roundtable Discussion 6:10 Join Main Conference Cocktail Reception
    • Day One 2:40 Choose from 4 Workshops (A-D) Day One 4:40 Choose from 3 Workshops (E-G) A E The Role of Compliance in GMP • DOJ 2014 enforcement priorities — Frank Rivas, Vice President, Compliance and Integrity Programs, Becker and Associates Consulting A focus on safety • Quality and GMP for manufacturers • Supplier and material control issues • Complaint handling • Third-party oversight Effective Crisis Management for Compliance — Take Preparation to a Different Level • Manage emerging issues surrounding enforcement and new scrutiny surrounding GMPs B Specialty Products — Unique Compliance Challenges for High-Cost Products and the High-Touch Services Used for Promotion and Marketing • Understand the impact of • Discuss the need for outside Roger Schmitt, Vice President, Quality and Regulatory Affairs, Luitpold Pharmaceuticals Wick Sollers, Partner, Special Matters and Government Investigations, King & Spalding LLP Dan McGinn, President, McGinn and Company * emerging nations • Prepare for major investigations — Before, during and after Sunshine provisions * effectively manage media scrutiny * HEOR information crisis management and vendor management for costly, high-touch services sales teams in working with physician offices for high cost products, including for those brands where buy & bill is an option • Understand the full range of pharma funded reimbursement services and support models in order to better manage your company’s risk profile for specialty brands Ted Hester, Partner, Government Advocacy and Public Policy, King & Spalding LLP Seth H. Lundy, Partner, FDA & Life Sciences, King & Spalding LLP • Explore the inherent dangers for • Learn about trends in specialty distribution networks and models that raise compliance and price reporting challenges Rujul H. Desai, President, Occam Health Services • Discover compliance best practices in vendor selection Effective Compliance Training Tactics and Techniques — Engaging the Organization C • LIMS — Adherence to • Government focus on anti-corruption Gary Giampetruzzi Vice President and General Counsel, Head of Government Investigations, Pfizer Inc enforcement in the U.S., China and elsewhere * The more recent enactment of anti-corruption regimes • Dodd-Frank, the plaintiffs bar and a new wave of potential whistleblowers worldwide cases and enforcement actions * Best practices for anti-corruption compliance in BRIC and other high risk markets training — Policies and procedures translated for foreign countries • Nuances lost in translation can be caught to review translations Abby Dionne, Director, Learning and Communications, Global Ethics and Compliance, Merck/MSD • Adherence to curriculums G Considerations During Investigations and Audits — What Are We Missing • The evolving role and focus of the audit function in the anti-corruption and FCPA space • Discuss the different types of investigations (off-label, anti-kickback, Fair Market Value, FCPA, etc.) and the unique considerations of each • Leading edge strategies and controls, including enhanced monitoring, to mitigate risk D • Best practices for conducting Utilizing Compliance Monitoring Data to Inform Business Practices track compliance metrics across an organization • International issues for compliance Richard Konzelmann, Senior Manager Compliance Audits, Daiichi Sankyo • Review lessons learned from recent Maureen McGirr, J.D., Vice President, Office of Ethics & International Compliance, Merck & Co., Inc different curriculums FCPA — Key Insights and Enforcement Trends • Develop Key Performance Indicators to F * cross-functional team proactive investigations, internally, with the support of employees, external consultants and third-party auditors • Considerations in communicating findings to regulators and how to prepare for external investigations Clarissa Crain, Vice President, Strategic Consulting, Compliance Implementation Services * embedded within business processes and decision making • Share examples of KPIs and how 6:10 they are tracked * commercial * R&D • Address ways to identify risks within an organization * risk assessment Close of Breakouts and Day One Anthony Brennan, Senior Director, HCC Governance, Metrics and Reporting, Johnson and Johnson * gap analysis • Importance of monitoring outside of CIA requirements * share examples of additional monitoring areas Michael Driscoll, Healthcare Compliance, Johnson and Johnson * independent vs. embedded monitoring • Utilizing monitoring results and data to inform business decisions 4:10 Networking Break Networking Wine and Cheese Reception will Commence at Close of Day One
    • Main Conference Day Two — Wednesday, January 29, 2014 7:00 Main Conference Registration and perspective of the Department of Justice to 10:15 Continental Breakfast enhance understanding of government focus and Compliance as a True Business high risk areas. Partner — Achieve an Internal Compliance 8:00 Day Two Chairperson’s Welcome and Opening Remarks Cynthia “Cindy” Cetani, Vice President, Ethics and Compliance and Chief Compliance Officer, Novartis Pharmaceuticals Corporation • Increase awareness of FCPA risk for individuals and companies to improve compliance • Discuss the scope of FCPA and the overarching and unique impact on industry • Review recent cases and examples of civil and criminal penalties FDA/CDER ADDRESS Anticorruption Policy Counsel Top Priorities for Oversight at FDA and Trial Attorney, • Review FDA initiatives to protect public Fraud Section health through risk and science-based policy, surveillance and enforcement • Assess recent enforcement trends and high-risk areas that affect the pharmaceutical industry • Receive an overview of FDA priorities, policies and strategies 9:35 Making Compliance Part of an organization • Analyze how to foster communication between business and compliance • Understand issues in different sized organizations and determine how much compliance is enough * resources? * team size? MODERATOR: Wayne Brody, LRN – Inspiring Principal Performance formula to organize and drive its workforce. The formula is a set of tools designed to their highest performance. These tools include PharmD., J.D., Deputy Director, setting a financial target, then driving the Office of Compliance, Center for workforce to hit that target through tailored Drug Evaluation and Research, objectives, mid and year-end performance reviews Food and Drug Administration and rewards for success and consequences for failure. Through this, the value and contributions Breaches of Trust: • Discuss the changing role of the CCO in Every company uses the same management Ilisa B.G. Bernstein, 8:40 • Create a culture of compliance that adapts to Management 101 continuously pressure the workforce to extract Culture Working with the Business changing regulations programs Kathleen M. Hamann, 8:05 CCO PANEL of each employee are continuously monitored PANELISTS: Jeffrey E. Fleming, Vice President Compliance, North America, AstraZeneca Sarah Whipple, Vice President, Chief Compliance Officer, Aegerion Pharmaceutical Compliance to Prevent Corruption and measured. These tools are a double-edged In this conversation with the New Jersey U.S. sword, however, because the root-cause of many Matthew Allegrucci, Attorney, hear from the head of an office known compliance violations is not intentional fraud or General Counsel, for prosecuting corruption in a state distinguished misconduct, but rather, the unrelenting pressure Chief Compliance Officer, by its robust pharmaceutical industry. Understand exerted by management to hit short-term financial Daiichi Sankyo how prosecutors view corruption, whether targets. Hear how to prevent culture-driven political, the result of a broken compliance culture compliance violations and promote long-term Matthew D’Ambrosio, or the greed of individual health care providers. business success by embedding compliance into Senior Vice President Get information you can use on how DOJ sees every aspect of management. and Chief Compliance Officer, Sunovion Pharmaceuticals Inc. corporate culpability and an inside view of best practices and cautionary tales in the cyber world. Patrik Florencio, Vice President and Chief Corporate U.S. Attorney Paul J. Fishman, Compliance Officer, Sandoz North U.S. Attorney’s Office for the America, Sandoz District of New Jersey Samuele Butera, 9:05 Foreign Corrupt Practices Act — Impact on Pharmaceutical and Biotech Industries Vice President and Head Biopharmaceuticals, Sandoz North America, Sandoz Pharmaceutical and Biotech companies face unique FCPA risks, therefore, it is crucial to understand bribery trends in order to shape internal compliance policies to minimize the risk of a violation. In this address, benefit from the Erik Ramanathan, Senior Fellow, Harvard Law School Program on the Legal Profession, Harvard Law School www.cbinet.com/pcc 11:00  Networking and Refreshment Break
    • Day Two 11:30 Choose from 5 Comprehensive Tracks (5-9) 5 GLOBAL ABAC AND INTERNATIONAL COMPLIANCE STRATEGIES 11:30 Vincent Hom, Executive Director, Fraud Investigations and Dispute Services, Ernst & Young LLP OFF-LABEL RISKS AND CONTROLS • Discuss anti-bribery and anti-kickback concerns • Review recent issues from specific emerging nations * China * South America * India * etc. 11:35 Distributor Relationships, Third-Party Due Diligence and System Audits • Contracts and relationships in place that connect mission to audit third-parties Kip Ebel, Principal, Life Sciences Assurance, Ernst & Young LLP Vincent Walden, Partner, Fraud Investigation & Dispute Services, Ernst & Young LLP 12:15 Emerging Markets — Compliance Considerations • Manage and identify risks through thorough risk assessments • Verify data and information from partners and third-parties in emerging nations 11:30 6 Track Chair’s Opening Remarks Track Chair’s Opening Remarks Geoff Levitt, Chief Regulatory Counsel, Pfizer Inc 11:35 Role of Medical Affairs in Product Communications • Discuss scientific exchange in light of the delay in the final guidance • Analyze the relationship between medical affairs and sales teams • Medical/scientific communication in other settings • Understand the role of medical affairs in various settings * speaker programs Marc Miller, Partner, Life Science Regulatory Compliance Services, KPMG LLP 12:55 CASE STUDY Largest Drug Safety Settlement for cGMP Violations and False Statements to the FDA • Review lessons learned from U.S. FDA/DOJ prosecution of Ranbaxy Laboratories • Analyze this case study to help identify and fix problems • Create harmonization between policies and people leading to better compliance with cGMPs Dinesh S. Thakur, Plaintiff/Relator, US ex. rel. Thakur vs. Ranbaxy Laboratories Limited 12:15 Speaker Programs — A 30,000 Foot View • Discuss enterprise-wide selection criteria, training and responsibilities of HCPs as company • Discuss internal employee training and responsibilities • Ensure compliant speakers by establishing safeguards and mitigating risks Timothy Grimes, Health Care Compliance Officer, Johnson & Johnson Samantha Hand, Training Manager, JJHCC&P, Johnson & Johnson 12:55 Evolution of Off-Label — Understand the Current Environment for Off-Label and Misbranding Compliance • Discuss nuances of what is, and what isn’t, off-label • Indications for signs and symptoms • Recent off-label cases and lessons learned * relationships with HCPs * social media response * pre-approval communications Michelle Axelrod, Principal, Porzio, Bromberg & Newman P.C. Emily Wright, Senior Corporate Counsel, Pfizer Inc Attendee Profile by Function by Level 56% Compliance/Ethics/Audit 25% Legal/Counsel 6% Regulatory/Medical Affairs 28% Executive/VP/Chief 26% Director/Senior Director 26% Counsel/Officer/Principal 5% Sales/Consulting 5% Business Operations/Strategy 3% IT/IS 13% Manager/Senior Manager 7% Analyst/Specialist
    • Day Two 11:30 Choose from 5 Comprehensive Tracks (5-9) 7 COMPLIANCE PROGRAM STRUCTURE AND EFFECTIVENESS 11:30 Track Chair’s Opening Remarks MODERATOR: Ed Nowicki, Vice President and Assistant General Counsel, Pfizer Inc 11:35 Strategies to Implement Successful, Multi-National Compliance Programs • Review the impact of cultural considerations in multi-national compliance programs • Discuss potential risks and strategies to mitigate multi-national considerations • Understand challenges associated with multi-national standardized compliance programs, especially those headquartered outside of the U.S. Jessica Kwon, Global Compliance, Forest Laboratories, Inc. Garineh Dovletian, Vice President, Head of Global Contracting and Business Ethics, The Medicines Company 12:05 Improve Integration of Risk Mitigation Plans throughout the Business • Explore the collaboration between compliance, commercial and regulatory • Improve initial communication inter-departmentally • Instill policy owner accountability and involvement in development of individual compliance activities Kris Curry, Principal, Fraud Investigations and Dispute Services, Ernst & Young LLP PANELISTS: Peter Agnoletto, CPA, Senior Director, North America Compliance Team, Sanofi US Ed Nowicki, Vice President and Assistant General Counsel, Pfizer Inc Roger Louis, Senior Vice President, Compliance and Risk Management, Chief Compliance Officer, Cubist Pharmaceuticals 12:55 Compliance and the Business — Make Impactful Changes through Partnerships with the Business • Understand the importance of involving the business in compliance decisions • Work in tandem with the business to create impactful solutions • Hear real-world examples of impactful compliance changes made in the business Bob Doyle, Executive Director, Commercial Compliance, Boehringer Ingelheim Christine Fiore, Compliance Business Partner, Boehringer Ingelheim 11:30 Track Chair’s Opening Remarks Chris Castro, Associate Director, Navigant 11:35 PANEL Sales Force Compliance and Oversight • Discuss the risk associated with potential bad actions in the field 8 FIELD FORCE OVERSIGHT * assess how to minimize risk • Analyze considerations for CIAs • Understand the importance of sales training • Examine challenges associated with co-promotion and alliances • Review the challenges associated with re-coupment plans MODERATOR: Paul Silver, Managing Director, Practice Leader Huron Life Sciences PANELISTS: Tracy Mastro, Senior Director, Huron Life Sciences 12:15 Effectively Manage and Improve Compliant Interaction between Field-Based Sales and MSL Teams • Assess challenges and risks surrounding interactions between field-based sales and MSLs • Review compliance considerations for internal communications between medical affairs and commercial departments • Discuss scenarios and solutions for compliant interactions between sales and MSLs Erin Parsons, Health Care Compliance Director, Medical and Scientific Affairs, Johnson & Johnson Angela Wood, Health Care Compliance Officer, Johnson & Johnson 12:55 Implementing a Compliance Monitoring Program • Examine the typical universe of monitoring activities • Create a plan to address areas of greatest risk • Match approaches and resources to execute the monitoring plan • Develop documentation and communication of outcomes to relevant business partners Dennis K. Barnes, Esq., CPA, Senior Director, North America Compliance, Sanofi US Cynthia Ham, US General Counsel and Chief Compliance Officer, ProStrakan, Inc. Greg Pellicano, Vice President, Deputy Compliance Officer, Shire Joe Calarco, Director, Global Compliance Monitoring & Investigations, Shire
    • Day Two 11:30 Choose from 5 Comprehensive Tracks (5-9) 11:30 12:35 PANEL Best Practices for Report Filing Track Chair’s Opening Remarks John Oroho, Principal, Porzio, Bromberg & Newman P.C. 11:35 Why Sunshine? The Purpose Behind Being Open • Identify the goal of Aggregate Spend tracking moving SUNSHINE AND OPEN PAYMENTS COMPLIANCE 9 • CMS system requirements • Considerations for non-CIA companies • Reporting information regarding physician recruitment • Reporting requirements for reprints Victoria Browning, Senior Director, Corporate Compliance Operations, Allergan forward to March 31st • Risks and assumptions surrounding Sunshine • Understand the reasons behind the Sunshine Act Richard F. Eschle, Pharm.D., JD, Senior Director, Corporate Ethics and Compliance, Erik Eglite, Vice President, Chief Compliance Officer and Corporate Counsel, Lundbeck Pharmaceuticals Eisai Inc. 12:05 Strategies for Dispute Resolution and Dispute Processes • Dispute resolutions • Governance of data • Agencies looking at data outside of CMS • Discuss what is being done with data by different groups Gus Papandrikos, Director, Compliance, Daiichi Sankyo Daina Selvig, Director, Corporate Compliance, Ironwood Pharmaceuticals Gaurica Manchanda-Chacko, Senior Director, Global HCP Compliance, Edwards Lifesciences Suj Patel, Director, Huron Life Sciences 1:05 Benefits of a Data-Driven, Sunshine Act Compliance Assessment • The need for conducting assessments and addressing relevant risks • Benefits of using Big Data analysis techniques • Assessment examples, including scope, timing and output • Suggested data routines Marci Juneau, Director, Huron Life Sciences 1:35 Andy Parks, Director, Life Sciences Regulatory Compliance Services, KPMG LLP Rick Zimmerer, Partner, KPMG LLP Jon Smollen, Executive Vice President, Corporate Compliance, Endo Health Solutions Inc. Luncheon Day Two 2:35 Choose from 5 Discussions (A-E) Engage in small group conversation with your peers during these Working Group Discussions. Facilitators share first-hand experiences and ask specific questions to help spark dialogue surrounding the practical issues around each topic area. A C Overlap of Compliance Activities and Responsibilities between Generic and Branded Divisions within Companies Re-thinking How You Conduct a Risk Assessment FACILITATORS: Tammy Brintzinghoffer, Senior Manager, HCC Governance & Reporting, Johnson & Johnson SanDee Priser, Partner, Fraud Investigation and Dispute Services, Ernst & Young LLP Jennifer Shimek, Senior Manager, Fraud Investigation and Dispute Services, Ernst & Young LLP Compliance Considerations for Small to Mid-Sized Companies Michael Clarke, Vice President, Ethics & Compliance – Americas, Actavis Inc. Arthur J. Corrado, Compliance Officer – Pharmaceuticals, Endo Health Solutions Inc. D Code of Conduct Training, Communication and Integration FACILITATOR: FACILITATORS: David Stollman, Chief Compliance Officer, Incyte Jim Heintzelman, Deputy Compliance Officer, Endo Health Solutions Inc. Bret S. Bissey, MBA, FACHE, CHC, Senior Vice President, Compliance Services, MediTract, Inc. B Timothy Ayers, Principal, Porzio, Bromberg & Newman P.C., Former VP, Chief Compliance Officer, Dendreon FACILITATORS: Peter Sandford, Executive Vice President, NXLevel Solutions Elizabeth V. Jobes, Senior Vice President, Chief Compliance Officer, Auxilium Jeffrey Rosenbaum, Vice President, Chief Compliance Officer, Vertex Pharmaceuticals 4:10 E The Affordable Care Act and Healthcare Reform on Compliance FACILITATOR: Close of Conference Scott Liebman, Principal, Porzio, Bromberg & Newman P.C.
    • Distinguished Sponsors ABOUT OUR PLATINUM FOUNDATION SPONSOR Platinum Foundation Sponsor Fraud Investigation & Dispute Services, Life Sciences Team Tighter competition, regulatory scrutiny and tough enforcement heighten the risk of litigation and non-compliance. In your industry, compliance issues and risk factors need to be addressed at every turn, from research and development to marketing strategies and supply chain integrity, while the scrutiny of regulators and customers alike is increasing and rapidly changing. Our professionals understand the complex issues facing pharmaceutical, biotechnology and medical device companies. We have established experience helping companies evaluate and manage those aspects of their businesses that pose the greatest potential risks. Our dedicated team includes CPAs, government contract analysts, economists, licensed pharmacists and certified fraud examiners, as well as former pharmaceutical executives, ethics and compliance officers and government auditors, investigators and prosecutors. For more information visit ey.com/us/fids or contact Ted Acosta, Principal, Fraud Investigation & Dispute Services, Life Sciences Leader at (212) 773-3022. ABOUT OUR COMPLIANCE CONSULTING LEADERS CIRCLE Bronze Sponsor ABOUT OUR LEGAL LEADERS CIRCLE Bronze Sponsor . With deep industry experience, insight, and technical support, KPMG LLP is one of the largest providers of audit, tax and advisory services to pharmaceutical and life sciences companies. We help clients gain practical insight into emerging issues, consider approaches to balance risk and controls, improve performance and explore the accelerating transformation of this industry, both domestically and globally. For more information about KPMG, please call the KPMG Hotline at 1-877-679-KPMG (5764) or visit us at us.kpmg.com. Associate Sponsors Celebrating more than 125 years of service, King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with 800 lawyers in 17 offices in the United States, Europe, the Middle East and Asia. The firm has handled matters in over 160 countries on six continents and is consistently recognized for the results it obtains, uncompromising commitment to quality and dedication to understanding the business and culture of its clients. For more information about our FDA & Life Sciences practice, please contact Ed Basile at ebasile@kslaw.com or Seth Lundy at slundy@kslaw.com Navigant (NYSE: NCI) is a specialized, global expert services firm dedicated to assisting clients in creating and protecting value in the face of critical business risks and opportunities. Through senior-level engagement with clients, Navigant professionals combine technical expertise in Disputes and Investigations, Economics, Financial Advisory and Management Consulting, with business pragmatism in the highly regulated Construction, Energy, Financial Services and Healthcare industries to support clients in addressing their most critical business needs. Congress Sponsors & Exhibitors C O M P L I A N C E IMPLEMENTATION SERVICES Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating thought leadership and sharing expertise. For additional information on sponsorship or exhibit opportunities, please call Taylor Biggers at (339) 298-2108 or email taylor.biggers@cbinet.com
    • Congress Media Partners LEAD MEDIA PARTNER ADDITIONAL MEDIA PARTNERS VENUE ACCOMMODATIONS: The Ritz-Carlton To receive CBI’s special discounted hotel rate: 1150 22nd Street, NW Online: cbinet.com/pcc Washington, DC 20037 Phone reservations: 800-241-3333 or Reservations: 800.241.3333 202-835-0500 (mention CBI’s PCC) Direct Line: 202.835.0500 REGISTRATION FEE: Advantage Pricing* 2,199 $ Book Now! The Ritz-Carlton is accepting reservations on a space and rate availability basis. SUBSTITUTION & CANCELLATION Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. Cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $399 administrative charge. No refunds will be made after this date; however, the registration fee less the $399 administrative charge can be credited to another CBI conference if you register within 30 days from the date of this conference to an alternative CBI conference scheduled within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the conference registration fee only. CBI reserves the right to alter this program without prior notice. Please Note: speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made without notice. The opinions of the conference faculty do not necessarily reflect those of the Standard Pricing All travel arrangements are subject to availability. 2,599 Now Offering Credit Hours Towards: Academic/Gov’t Rooms are limited so please book early. • CLE $ TEAM DISCOUNT: Attend this conference FREE if you bring THREE registered colleagues from your 1,399 $ organization or external to your organization • CPE •  CB C (enables cross-company teams). Team registrations must be made at the same time to Advantage Pricing: qualify. To receive the team discount you must Register by 12/6 and save $400! register with our customer service department by calling 339-298-2100. SATISFACTION GUARANTEED: CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable CBI conference of your choice. Please contact 800-817-8601 for further information. Advanced preparation for CBI conferences is not required. *Pending Approval *Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.) PLEASE NOTE: All advertised discounts are taken from the final, Standard Rate. companies they represent or CBI. PC14001 Four ways to register now! 2 3 4 WEBSITE EMAIL PHONE LIVE CHAT cbinet.com/pcc roberts.apse@cbinet.com 800.817.8601 cbinet.com/pcc 1
    • TH 11 John Crisan Chief Compliance Officer Johnson & Johnson JANUARY 28-29, 2014 • THE RITZ-CARLTON • WASHINGTON, DC Thomas W. Abrams, R.Ph., MBA Director Office of Prescription Drug Promotion, FDA Bill Killian U.S. Attorney U.S. Attorney’s Office for the Eastern District of Tennessee Jeffrey E. Fleming Vice President Compliance North America AstraZeneca Zane David Memeger, Esq. U.S. Attorney U.S. Attorney’s Office for the Eastern District of Pennsylvania Michael Parini, Senior Vice President, Chief Litigation Counsel Pfizer Inc 1 Choice for Compliance Carmen Ortiz U.S. Attorney U.S. Attorney’s Office for the Eastern District of Massachusetts 50+ Sessions Elizabeth V. Jobes, Senior Vice President, Chief Compliance Officer Auxilium John Roth Director, Office of Criminal Investigations FDA Cynthia “Cindy” Cetani Vice President, Ethics and Compliance and Chief Compliance Officer Novartis Pharmaceuticals Corporation PCC 2014 Howard Sklamberg Director, Office of Compliance Center for Drug Evaluation and Research, FDA (Invited) Samuele Butera Vice President and Head Biopharmaceuticals, Sandoz North America, Sandoz 90+ Industry Experts LEGAL LEADERS CIRCLE save 400! —Erik Eglite, Vice President, Chief Compliance Officer and Corporate Counsel, Lundbeck Inc. ANY QUESTIONS OR TO REGISTER CALL Roberts Apse 339-298-2290 OR FAX TO MY ATTENTION 781-939-2459 email: roberts.apse@cbinet.com “ BI provides the most professional, C balanced and broad scope forum for exchange of information. I highly endorse this conference and its provider.” CBI 600 Unicorn Park Drive Woburn, MA 01801 www.cbinet.com/pcc Register by 12/6 and $ CCO Summit Host COMPLIANCE CONSULTING LEADERS CIRCLE Bronze Sponsor 11 Platinum Foundation Sponsor Bronze Sponsor Associate Sponsor www.cbinet.com/pcc PCC 2014 TH THE RITZ-CARLTON • WASHINGTON, DC