pcc 2014 – 11th annual pharmaceutical compliance congress

www.cbinet.com/pcc

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

http://www.cbinet.com/conference/PC14001

http://www.cbinet.com

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)


4:40 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


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


11:30 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


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


“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)

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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


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)

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1:40 Networking Luncheon and Invitation-Only CCO Summit



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


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


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.


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)


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


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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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


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


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


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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


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

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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


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 [email protected]

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 [email protected] or Seth Lundy at [email protected]

LEAD MEDIA PARTNER

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VENUE

The Ritz-Carlton1150 22nd Street, NW Washington, DC 20037Reservations: 800.241.3333Direct Line: 202.835.0500

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.

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.

REGISTRATION FEE:

Advantage Pricing*

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Standard Pricing

$2,599

Academic/Gov’t

$1,399

Advantage Pricing:

Register by 12/6 and save $400!

*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

• CPE

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Four ways to register now!

3PHONE

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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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