pcc 2014 – 11th annual pharmaceutical compliance congress
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PCC 2014JANUARY 28-29, 2014 • THE RITZ-CARLTON • WASHINGTON, DC
11TH
John CrisanChief Compliance Officer
Johnson & Johnson
Cynthia “Cindy” CetaniVice President, Ethics and Compliance
and Chief Compliance Officer Novartis Pharmaceuticals Corporation
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
Jeffrey E. FlemingVice President Compliance
North America AstraZeneca
The Honorable William C. Killian, U.S. Attorney,
U.S. Attorney’s Office for theEastern District of Tennessee
Ilisa B.G. Bernstein, PharmD., J.D., Deputy Director, Office of Compliance, Center for Drug
Evaluation and Research, Food and Drug Administration
Thomas W. Abrams, R.Ph., MBADirector
Office of Prescription Drug Promotion, FDA
Elizabeth V. Jobes, Senior Vice President,
Chief Compliance Officer Auxilium
Michael Parini, Senior Vice President,
Chief Litigation Counsel Pfizer Inc
Carmen Ortiz U.S. Attorney
U.S. Attorney’s Office for the Eastern District of Massachusetts
Samuele Butera Vice President and Head
Biopharmaceuticals, Sandoz North America, Sandoz
Platinum Foundation Sponsor CCO Summit Host
COMPLIANCE CONSULTING LEADERS CIRCLE LEGAL LEADERS CIRCLE
Bronze SponsorBronze Sponsor
Associate Sponsors
90+ Industry Experts 50+ Sessions 1 Choice for Compliance
Day One — Tuesday, January 28, 2014
Agenda at a Glance
7:00 Main Conference Registration and Continental Breakfast
8:00 Day One Chairman’s Welcome and Opening Remarks
8:05 Platinum Foundation Sponsor’s Welcome and Opening Remarks
8:15 CMS ADDRESS
Review of Open Payments
8:45
FDA/OPDP ADDRESS
An Update on Promotional Guidance, Enforcement and Oversight Trends from the OPDP
9:15 U.S. ATTORNEY’S OFFICE ADDRESS
Enforcement Perspective — 2014 High Priority Areas
9:45 ENFORCEMENT PANEL
U.S. Healthcare Fraud Enforcement — Trends and Top Priorities
10:25 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
Day One TRACKS
1 THE BASICS IN HCC AND POLICY APPLICATIONS
2 PRODUCT PROMOTIONAL COMPLIANCE
3 GLOBAL TRANSPARENCY OF HCP SPEND
4
COMPLIANCE CONSIDERATIONS FOR
CLINICAL RESEARCH AND PRE-APPROVAL
COMMUNICATIONS
A 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
DUTILIZING COMPLIANCE
MONITORING DATA TO INFORM BUSINESS
PRACTICES
E
EFFECTIVE CRISIS MANAGEMENT FOR
COMPLIANCE — TAKE PREPARATION TO
A DIFFERENT LEVEL
F
ENGAGE THE ORGANIZATION —
EFFECTIVE COMPLIANCE TRAINING TACTICS AND TECHNIQUES
GCONSIDERATIONS
DURING INVESTIGATIONS AND AUDITS —
WHAT ARE WE MISSING?
Day One WORKSHOPS
PCC 2014
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Day Two — Wednesday, January 29, 2014
7:00 Main Conference Registration and Continental Breakfast
8:00 Day Two Chairperson’s Welcome and Opening Remarks
8:15FDA/CDER ADDRESS
Top Priorities for Oversight at FDA
9:00 Making Compliance Part of Management 101
10:00
CCO PANEL
Compliance as a True Business Partner — Achieve an Internal Compliance Culture Working with the Business
11:00 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
5GLOBAL ABAC AND
INTERNATIONAL COMPLIANCE STRATEGIES
6 OFF-LABEL RISKS AND CONTROLS
7COMPLIANCE PROGRAM
STRUCTURE AND EFFECTIVENESS
8 FIELD FORCE OVERSIGHT
9 SUNSHINE AND OPEN PAYMENTS COMPLIANCE
Day Two TRACKS
ARE-THINKING HOW YOU CONDUCT A
RISK ASSESSMENT
BCOMPLIANCE
CONSIDERATIONS FOR SMALL TO MID-SIZED COMPANIES
C
OVERLAP OF COMPLIANCE ACTIVITIES AND RESPONSIBILITIES
BETWEEN GENERIC AND BRANDED DIVISIONS
WITHIN COMPANIES
DCODE OF CONDUCT
TRAINING, COMMUNICATION AND INTEGRATION
ETHE AFFORDABLE CARE ACT AND HEALTHCARE REFORM
ON COMPLIANCE
Day Two INTERACTIVE DISCUSSIONS
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 & Compliance- Americas, 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
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
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Main Conference Day One — Tuesday, January 28, 2014
7:00 Main Conference Registration and Continental Breakfast
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
Anita Griner, MBA, PMP, Acting Director, Data Sharing & Partnership Group, CMS Center for Program Integrity
8:45 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
Thomas W. Abrams, R.Ph., MBA, Director, Office of Prescription Drug Promotion, FDA
9:15 U.S. ATTORNEY’S OFFICE ADDRESSEnforcement 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
and prosecutions, as well as the deterrent effect of prosecutions relating to the pharmaceutical employees, physicians and HCPs.
Carmen M. Ortiz, U.S. Attorney, U.S. Attorney’s Office for the District of Massachusetts
9:45 ENFORCEMENT PANEL
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
MODERATOR:
Kathleen Meriwether, Principal, Fraud Investigation & Dispute Services, Ernst & Young LLP
PANELISTS:
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 Caroli na
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
Rebecca C. Martin, Deputy Chief, Civil Frauds Unit, Healthcare Fraud Coordinator, United States Attorney’s Office, Southern District of New York
Benjamin D. Singer, Deputy Chief, U.S. Department of Justice Criminal Division, Fraud Section
10:25 DEFENSE PANEL
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
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
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Day One 11:30 Choose from 4 Comprehensive Tracks (1-4)
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11:35 Lessons Learned from Recent Enforcement Actions Related to Digital Marketing and Social Media
• Learn from recent OPDP enforcements to
enhance digital and social media compliance
• Improve understanding of compliance considerations for
social and digital campaigns
• Enhance communication between compliance
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
on social media marketing
• Analyze compliance considerations caused by the
increasing role of social media and technology
• 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
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
Howard L. Dorfman, Vice President, General Counsel,
Ferring Pharmaceuticals Inc.
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
or the pharmaceutical industry and provides participants
foundational knowledge in healthcare compliance basics.
I. Core Components Driving PharmaceuticalCompliance 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
fundamentals of successful compliance programs
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
“This CBI conference provided an excellent format to learn as well as build relationships across the industry.” — Samantha Hand, Manager, Training Risk Mitigation and CIA Management, Johnson & Johnson
Day One 11:30 Choose from 4 Comprehensive Tracks (1-4)
3
GLO
BA
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SPA
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NC
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HC
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4
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1:40 Networking Luncheon and Invitation-Only CCO Summit
11:30 Track Chair’s Opening Remarks
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
Dana Thomas Director, Account Management, Science Unit Transparency & Reporting (SUTAR), AstraZeneca
12:15 Global HCP Contracting and Data Collection
• Discuss best practices for deploying a global process 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
• Learn how to develop and implement a single, global and robust USA to the Rest Of the World G2L compliance, transparency and regulatory solution
• Understand from real examples how EMEA countries are co-operating cross border
• Gain an understanding on the corporate IT integration and critical data needed to develop and implement a G2L solution
Francis Geysermans, CTO, BMI SYSTEM
11:30 Track Chair’s Opening Remarks
Dennis K. Barnes, Esq., CPA, Senior Director, North America Compliance,
Sanofi US
11:35 Compliance Implications Surrounding Outsourced Clinical Trials
• Review responsibilities for oversight of CROs
• Understand transparency requirements around clinical trials
• Analyze Sunshine regulations regarding clinical payments
to HCPs
• Discuss operational considerations and risk assessments of
largely outsourced trials
Sue Seferian, Health Care Compliance Officer,
Johnson & Johnson
Eileen Erdos, Principal, Fraud Investigation and Dispute Services,
Ernst & Young LLP
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
Yolanda Lyle, Assistant General Counsel, Chief Compliance Counsel,
Research and Development/Medical, Pfizer Inc
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
data integrity issues
• Use of data to characterize risks in compliance GAPS
• Understand the importance of written research agreements
• Learn strategies for remediation after GAPS are identified
Colleen Hittle, Managing Director,
Navigant
“This CBI conference provided an excellent format to learn as well as build relationships across the industry.” — Samantha Hand, Manager, Training Risk Mitigation and CIA Management, Johnson & Johnson
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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, Vice President, Chief Compliance Officer, Associate General Counsel, Horizon Pharma
3:10 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
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.
HOSTED BY
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 Internet-based 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.
Chief Compliance Officer Summit
Day One 2:40 Choose from 4 Workshops (A-D)
A
B
C
D
4:10 Networking Break
• 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
• Learn about trends in specialty distribution networks and models that raise compliance and price reporting challenges
• Discover compliance best practices in vendor selection
and vendor management for costly, high-touch services
• Explore the inherent dangers for sales teams in working with physician offices for high cost products, including for those brands where buy & bill is an option
Rujul H. Desai, President, Occam Health Services
• DOJ 2014 enforcement priorities — A focus on safety
• Quality and GMP for manufacturers• Supplier and material control issues• Complaint handling • Third-party oversight
Frank Rivas, Vice President, Compliance and Integrity Programs, Becker and Associates Consulting
Roger Schmitt, Vice President, Quality and Regulatory Affairs, Luitpold Pharmaceuticals
Networking Wine and Cheese Reception will Commence at Close of Day One
• Government focus on anti-corruption 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
• Review lessons learned from recent cases and enforcement actions
* Best practices for anti-corruption compliance in BRIC and other high risk markets
• The evolving role and focus of the audit function in the anti-corruption and FCPA space
• Leading edge strategies and controls, including enhanced monitoring, to mitigate risk
Gary Giampetruzzi Vice President and General Counsel, Head of Government Investigations, Pfizer Inc
Richard Konzelmann,Senior Manager Compliance Audits,Daiichi Sankyo
Day One 4:40 Choose from 3 Workshops (E-G)
• Develop Key Performance Indicators to track compliance metrics across an organization
• Share examples of KPIs and how they are tracked* commercial* R&D
• Address ways to identify risks within an organization* risk assessment* gap analysis
• Importance of monitoring outside of CIA requirements* share examples of additional
monitoring areas* independent vs. embedded
monitoring• Utilizing monitoring results and data
to inform business decisions
* cross-functional team* embedded within business
processes and decision making
Anthony Brennan, Senior Director, HCC Governance, Metrics and Reporting, Johnson and Johnson
Michael Driscoll, Healthcare Compliance, Johnson and Johnson
E
F
G
6:10 Close of Breakouts and Day One
• Manage emerging issues surrounding enforcement and new scrutiny surrounding GMPs
* emerging nations• Prepare for major investigations —
Before, during and after• Understand the impact of
Sunshine provisions* effectively manage media scrutiny* HEOR information
• Discuss the need for outside crisis management
Ted Hester, Partner, Government Advocacy and Public Policy, King & Spalding LLP
Seth H. Lundy, Partner, FDA & Life Sciences, King & Spalding LLP
Wick Sollers, Partner, Special Matters and Government Investigations, King & Spalding LLP
Dan McGinn, President, McGinn and Company
• LIMS — Adherence to different curriculums
• International issues for compliance training — Policies and procedures translated for foreign countries
• Nuances lost in translation can be caught to review translations
• Adherence to curriculums
Maureen McGirr, J.D., Vice President, Office of Ethics & International Compliance, Merck & Co., Inc
• Discuss the different types of investigations (off-label, anti-kickback, Fair Market Value, FCPA, etc.) and the unique considerations of each
• Best practices for conducting 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
The Role of Compliance in GMP
Specialty Products — Unique Compliance Challenges for High-Cost Products and the High-Touch Services Used for Promotion and Marketing
FCPA — Key Insights and Enforcement Trends
Utilizing Compliance Monitoring Data to Inform Business Practices
Effective Crisis Management for Compliance — Take Preparation to a Different Level
Effective Compliance Training Tactics and Techniques — Engaging the Organization
Considerations During Investigations and Audits — What Are We Missing
Abby Dionne, Director, Learning and Communications, Global Ethics and Compliance, Merck/MSD
7:00 Main Conference Registration and
Continental Breakfast
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
8:05 FDA/CDER ADDRESS Top Priorities for Oversight at FDA
• Review FDA initiatives to protect public
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
Ilisa B.G. Bernstein,
PharmD., J.D., Deputy Director,
Office of Compliance, Center for
Drug Evaluation and Research,
Food and Drug Administration
8:40 Breaches of Trust: Compliance to Prevent Corruption
In this conversation with the New Jersey U.S.
Attorney, hear from the head of an office known
for prosecuting corruption in a state distinguished
by its robust pharmaceutical industry. Understand
how prosecutors view corruption, whether
political, the result of a broken compliance culture
or the greed of individual health care providers.
Get information you can use on how DOJ sees
corporate culpability and an inside view of best
practices and cautionary tales in the cyber world.
U.S. Attorney Paul J. Fishman,
U.S. Attorney’s Office for the
District of New Jersey
9:05 Foreign Corrupt Practices Act — Impact on Pharmaceutical and Biotech Industries
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
perspective of the Department of Justice to
enhance understanding of government focus and
high risk areas.
• Increase awareness of FCPA risk for individuals
and companies to improve compliance
programs
• Discuss the scope of FCPA and the overarching
and unique impact on industry
• Review recent cases and examples of civil and
criminal penalties
Kathleen M. Hamann,
Anticorruption Policy Counsel
and Trial Attorney,
Fraud Section
9:35 Making Compliance Part of Management 101 Every company uses the same management
formula to organize and drive its workforce.
The formula is a set of tools designed to
continuously pressure the workforce to extract
their highest performance. These tools include
setting a financial target, then driving the
workforce to hit that target through tailored
objectives, mid and year-end performance reviews
and rewards for success and consequences for
failure. Through this, the value and contributions
of each employee are continuously monitored
and measured. These tools are a double-edged
sword, however, because the root-cause of many
compliance violations is not intentional fraud or
misconduct, but rather, the unrelenting pressure
exerted by management to hit short-term financial
targets. Hear how to prevent culture-driven
compliance violations and promote long-term
business success by embedding compliance into
every aspect of management.
Patrik Florencio,
Vice President and Chief Corporate
Compliance Officer, Sandoz North
America, Sandoz
Samuele Butera,
Vice President and Head
Biopharmaceuticals, Sandoz North
America, Sandoz
Erik Ramanathan,
Senior Fellow, Harvard Law School
Program on the Legal Profession,
Harvard Law School
10:15 CCO PANEL Compliance as a True Business Partner — Achieve an Internal Compliance Culture Working with the Business • Create a culture of compliance that adapts to
changing regulations
• Discuss the changing role of the CCO in
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
PANELISTS:
Jeffrey E. Fleming, Vice President Compliance,
North America,
AstraZeneca
Sarah Whipple, Vice President,
Chief Compliance Officer,
Aegerion Pharmaceutical
Matthew Allegrucci, General Counsel,
Chief Compliance Officer,
Daiichi Sankyo
Matthew D’Ambrosio, Senior Vice President
and Chief Compliance Officer,
Sunovion Pharmaceuticals Inc.
11:00 Networking and Refreshment Break
www.cbinet.com/pcc
Main Conference Day Two — Wednesday, January 29, 2014
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Day Two 11:30 Choose from 5 Comprehensive Tracks (5-9)
11:30 Track Chair’s Opening Remarks
Vincent Hom, Executive Director, Fraud Investigations and Dispute Services, Ernst & Young LLP
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
• Discuss anti-bribery and anti-kickback concerns• Review recent issues from specific emerging nations
* China* South America* India
* etc.
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
11:30 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
* relationships with HCPs
* social media response
* pre-approval communications
Michelle Axelrod, Principal, Porzio, Bromberg & Newman P.C.
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
Emily Wright, Senior Corporate Counsel, Pfizer Inc
Attendee Profile
56% Compliance/Ethics/Audit
25% Legal/Counsel
6% Regulatory/Medical Affairs
5% Sales/Consulting
5% Business Operations/Strategy
3% IT/IS
28% Executive/VP/Chief
26% Director/Senior Director
26% Counsel/Officer/Principal
13% Manager/Senior Manager
7% Analyst/Specialist
by Function by Level
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Day Two 11:30 Choose from 5 Comprehensive Tracks (5-9)
11:30 Track Chair’s Opening Remarks
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
MODERATOR:
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
* 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
Dennis K. Barnes, Esq., CPA, Senior Director, North America Compliance, Sanofi US
Cynthia Ham, US General Counsel and Chief Compliance Officer, ProStrakan, Inc.
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
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)
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11:30 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 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, 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
Daina Selvig, Director, Corporate Compliance, Ironwood Pharmaceuticals
Suj Patel, Director, Huron Life Sciences
Marci Juneau, Director, Huron Life Sciences
Jon Smollen, Executive Vice President, Corporate Compliance, Endo Health Solutions Inc.
12:35 PANEL Best Practices for Report Filing
• 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
Erik Eglite, Vice President, Chief Compliance Officer and Corporate Counsel, Lundbeck Pharmaceuticals
Gus Papandrikos, Director, Compliance, Daiichi Sankyo
Gaurica Manchanda-Chacko, Senior Director, Global HCP Compliance, Edwards Lifesciences
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
Rick Zimmerer, Partner, KPMG LLP
Day Two 2:35 Choose from 5 Discussions (A-E)
1:35 Luncheon
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
B
C
D
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Re-thinking How You Conduct a Risk Assessment FACILITATORS:
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 FACILITATORS:
Timothy Ayers, Principal, Porzio, Bromberg & Newman P.C., Former VP, Chief Compliance Officer, Dendreon
David Stollman, Chief Compliance Officer, Incyte
Overlap of Compliance Activities and Responsibilities between Generic and Branded Divisions within Companies FACILITATORS:
Jim Heintzelman, Deputy Compliance Officer, Endo Health Solutions Inc.
Michael Clarke, Vice President, Ethics & Compliance – Americas, Actavis Inc.
Code of Conduct Training, Communication and IntegrationFACILITATOR:
Peter Sandford, Executive Vice President, NXLevel Solutions
4:10 Close of Conference
Arthur J. Corrado, Compliance Officer – Pharmaceuticals, Endo Health Solutions Inc.
Elizabeth V. Jobes, Senior Vice President, Chief Compliance Officer, Auxilium
Jeffrey Rosenbaum, Vice President, Chief Compliance Officer, Vertex Pharmaceuticals
The Affordable Care Act and Healthcare Reform on Compliance FACILITATOR:
Scott Liebman, Principal, Porzio, Bromberg & Newman P.C.
Tammy Brintzinghoffer, Senior Manager, HCC Governance & Reporting, Johnson & Johnson
Bret S. Bissey, MBA, FACHE, CHC, Senior Vice President, Compliance Services,MediTract, Inc.
Andy Parks, Director, Life Sciences Regulatory Compliance Services, KPMG LLP
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.
.
Distinguished Sponsors
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 Sponsors & ExhibitorsC O M P L I A N C E
IMPLEMENTATION SERVICES
ABOUT OUR COMPLIANCE CONSULTING 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
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.
ABOUT OUR LEGAL LEADERS CIRCLE
Bronze Sponsor
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
LEAD MEDIA PARTNER
VENUE
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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 companies they represent or CBI.
ACCOMMODATIONS:
To receive CBI’s special discounted hotel rate:Online: cbinet.com/pccPhone reservations: 800-241-3333 or 202-835-0500 (mention CBI’s PCC)
Book Now! The Ritz-Carlton is accepting reservations on a space and rate availability basis. Rooms are limited so please book early. All travel arrangements are subject to availability.
TEAM DISCOUNT:
Attend this conference FREE if you bring THREE registered colleagues from your organization or external to your organization (enables cross-company teams). Team registrations must be made at the same time to qualify. To receive the team discount you must register with our customer service department by calling 339-298-2100.
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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.
REGISTRATION FEE:
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$2,599
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Advantage Pricing:
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*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.
Now Offering Credit Hours Towards:• CLE
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Four ways to register now!
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“ CBI provides the most professional, balanced and broad scope forum for exchange of information. I highly endorse this conference and its provider.”
— Erik Eglite, Vice President, Chief Compliance Officer and Corporate Counsel, Lundbeck Inc.
CBI 600 Unicorn Park Drive Woburn, MA 01801
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90+ Industry Experts 50+ Sessions
1 Choice for Compliance
ANY QUESTIONS OR TO REGISTERCALL Roberts Apse 339-298-2290
OR FAX TO MY ATTENTION 781-939-2459email: roberts.apse@cbinet.com
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