pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress



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Day 2 | Day 3

   Preconference Symposia (Optional; Choose one)
   Wednesday, October 21, 2015






7:30 a.m.



Congress Registration Opens










8:00 a.m.



Preconferences Commence (Choose one)




PRECONFERENCE I



REGULATORY CONCEPTS: BASIC PRINCIPLES




8:00 a.m.




Welcome and Overview

James Gibney
Senior Director of Compliance, Regeneron Pharmaceuticals; Former Director, Worldwide Programs and US Investigations - Corporate Compliance, Pfizer, Tarrytown, NY (Moderator)










8:10 a.m.




INDs, NDAs and Drug Development

Natasha Leskovsek, RN, MPM, MBA, JD
Health Care and Life Sciences Regulatory Practice, Cooley, LLP, Washington DC










8:40 a.m.




Scientific Exchange

Saul Helman, MD, MBA
Managing Director and Life Sciences Practice Leader, Navigant Consulting, Inc., Indianapolis, IN










9:10 a.m.




Patient Safety: Pharmacovigilance and REMS

Dr. Seth B. Whitelaw
President and and CEO, Whitelaw Compliance Group, LLC, West Chester, PA










9:30 a.m.




Break







9:50 a.m.




Advertising and Promotion: HCPs and Consumers

Janet L. "Lucy" Rose, MBA
President, Lucy Rose and Associates, LLC; Former Director, DDMAC, FDA, Washington, DC










10:50 a.m.




Promotion to Payers and Government Price Reporting

John Shakow, Esq.
Partner, FDA and Life Sciences Practice, King & Spalding, Washington, DC










11:30 a.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE II



INNOVATIONS IN RISK ASSESSMENT, AUDITING AND MONITORING




8:00 a.m.




Welcome and Overview

Lori Alarimo, JD
Director, Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations, Navigant Consulting, Inc., Irvine, CA (Moderator)










8:10 a.m.




Incorporating Effective Record Reviews In Your Auditing & Monitoring Plan

Chris Castro, CCEP
Associate Director, Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations, Navigant Consulting, Inc., Phoenix, AZ










8:50 a.m.




Enhancing Sales Performance through Field Based Monitoring

Kerry Clem
Senior Vice President, Sales, Acorda Therapeutics, Ardsley, NY






Wendy Heckelman, PhD
President and Founder, WLH Consulting, Inc., Fort Lauderdale, FL










9:30 a.m.




Break







9:45 a.m.




Getting Ahead of the Game -- Utilizing Data and Other Operational Indicators to Identify Potential Compliance Issues Early

Gary Keilty
Managing Director, FTI, Washington, DC






Daniel L. Dovdavany, Esq.
Assistant General Counsel North America Litigation & Investigations, Sanofi US, Bridgewater, NJ










10:30 a.m.




Building a Compliance Data Analytics Capability

Amy Pawloski, CPA, CCEP
Head of US Compliance & Ethics Monitoring and Data Analytics, Bristol-Myers Squibb, Plainsboro, NJ










11:00 a.m.




Effective Field Monitoring Essentials to Consider when Working with Sales, Marketing and Medical Teams

Scot Steinheiser, CHC, CCEP
Managing Partner and Founder, Commercial Compliance Consulting, SCS Compliance Group LLC, Mundelein, IL






Gary Mendelsohn
Assistant Director, Corporate Compliance for Oncology, Astellas, Greer, SC










11:30 a.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE III



ADVANCED ISSUES IN DOMESTIC AND GLOBAL TRANSPARENCY AND ANALYTICS: TAKING THE DATA TO THE NEXT LEVEL




8:00 a.m.




Welcome and Overview

Edward Glynn, MBA
Principal, Ernst & Young LLP, New York, NY (Moderator)










8:10 a.m.




Exploring the Analytics Maturity Model: Capitalizing on your Investment in Aggregate Spend

Corey Dunbar, CFE
Senior Manager, Fraud Investigations & Dispute Services, Ernst & Young LLP, New York, NY










8:50 a.m.




Linking Aggregate Spend Data with Other Data Sources to Identify Compliance Trends, Learn about your Competitors and Provide Strategic Insights to the Business

Véronique Monjardet, PhD
Country Manager -- France, Polaris, Paris, France










9:30 a.m.




Break







9:50 a.m.




Advanced Analytics: The Art of the Possible in Providing Value-Added Insights to the Business

Samir Hans, MS
Principal, Deloitte, Washington, DC










10:30 a.m.




Using Company-specific and Open Payments Data to Ensure Accuracy and Gain Insights

Terrell Sweat, MBA
Compliance Director, Actelion Pharmaceuticals, South San Francisco, CA






Jonathan Wilkenfeld, MBA
President, Potomac River Partners, Vienna, VA










11:00 a.m.




Growing and Integrating Global Transparency Analytics

Nadeem "Ned" Mumtaz, MBA, MIS
Practice Leader and Associate Partner, Streebo Inc., Princeton, NJ






Dr. Seth B. Whitelaw
President and CEO, Whitelaw Compliance Group, LLC, West Chester, PA










11:30 a.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE IV



ADVANCED GLOBAL COMPLIANCES ISSUES




8:00 a.m.




Welcome and Overview

Nathaniel B. Edmonds, Esq.
Partner, Paul Hastings; Former Assistant Chief, Foreign Corrupt Practices Act Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC (Moderator)










8:10 a.m.




Doing Business in China in 2016

David J. Ludlow, Esq.
Partner, Sidley Austin, Washington, DC










8:40 a.m.




Is Brazil the Next Hot Spot?

Esther M. Flesch, Esq.
Partner, Trench, Rossi e Watanabe, A Baker McKenzie Affiliate, São Paulo, Brazil










9:10 a.m.




Managing Compliance Risks Presented by Pharma Suppliers and Vendors: Beyond QRM and GMP

Traci Coughlan, Esq.
Principal, Advisory Services, The Red Flag Group, Berlin, MD










9:40 a.m.




Break







10:00 a.m.




Applying Analytics to Compliance Programs Resulting in Informed Business Decisions

Joseph Coniker, GMP
Principal, National Practice Leader, Business Analytics, Grant Thornton, Philadelphia, PA










10:30 a.m.




Monitoring and Auditing of Third Parties

Jeff Antoon
Director Internal Audit, Johnson & Johnson, New Brunswick, NJ










11:00 a.m.




Application of Attorney-Client Privilege in the Context of Internal Cross-Border Bribery Investigations

Vivian Robinson, Esq.
Queen's Counsel, Partner, McGuireWoods; Former General Counsel of the UK Serious Fraud Office; Former Head QEB Hollis Whiteman Chambers, Recorder of the Crown Court and Former Treasurer of Inner Temple, London, UK










11:30 a.m.




Preconference Adjournment; Lunch on your Own




    Day I
    Wednesday, October 21, 2015









OPENING PLENARY SESSION




1:00 p.m.




Welcome and Introduction: PCF Co-Chairs

Matthew D'Ambrosio, JD, MBA
Senior Vice President, Chief Compliance and Ethics Officer, Sunovion Pharmaceuticals, Inc., Marlborough, MA (Co-chair)






Gary Del Vecchio
Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company, Plainsboro, NJ (Co-chair)






Elizabeth V. Jobes, Esq.
Head of Corporate Compliance and Legal Counsel, Spark Therapeutics, Philadelphia, PA (Co-chair)










1:15 p.m.




Keynote: OIG Update

Mary E. Riordan, Esq.
Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC






Introduction by Matthew D'Ambrosio, JD, MBA
Senior Vice President, Chief Compliance and Ethics Officer, Sunovion Pharmaceuticals, Inc., Marlborough, MA (Co-chair)










2:00 p.m.




AUSA Panel

Colin M. Cherico
Assistant US Attorney, United States Attorney's Office, Eastern District of Pennsylvania, Philadelphia, PA






Richard Robinson, Esq. (Invited)
Section Chief-Major Frauds, Criminal Division, United States Attorney's Office, Central District of California, Los Angeles, CA






K. Nathaniel Yeager, Esq.
Chief, Health Care Fraud Unit, United States Attorney's Office, District of Massachusetts, Boston, MA






John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Moderator)










2:45 p.m.




FBI's New Focus on FCPA Investigations

Jeffrey S. Sallet
National Chief of Public Corruption and Civil Rights, Federal Bureau of Investigation, Washington, DC






Introduction by Kris Curry, MBA
Principal, Fraud Investigation & Dispute Services, Ernst & Young LLP; Former Vice President, Health Care Compliance, Pharmaceuticals Group, Johnson & Johnson, Philadelphia, PA










3:15 p.m.



Break










3:45 p.m.




Keynote: FDA-OPDP Update

Thomas W. Abrams, RPh, MBA
Director, Division of Drug Marketing, Advertising and Communications, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, MD






Introduction by Janet L. "Lucy" Rose, MBA
President, Lucy Rose and Associates, LLC; Former Director, DDMAC, FDA, Washington, DC










4:15 p.m.




Chief Compliance Officer Roundtable: Now that the CIA is Completed, How is the Ethics and Compliance Program Evolving?

Melissa S. Barnes, Esq.
Chief Ethics and Compliance Officer, Eli Lilly and Company, Indianapolis, IN






Tricia Glover
Vice President, US Chief Compliance Officer, Teva Pharmaceuticals, Kansas City, MO






Jonathon Kellerman
Executive Vice President, Global Chief Compliance Officer, Allergan PLC, Parsippany, NJ






Lawrence P. Platkin
Vice President and Head, U.S. Compliance Center of Excellence, Bayer Corporation, Whippany, NJ






Trudy Tan, CPA
Vice President Compliance North America, AstraZeneca, Wilmington, DE






Erinn Hutchinson
Partner, Advisory Services, PwC, Philadelphia, PA (Moderator)










5:00 p.m.




Panel: FCPA Anticorruption: Examining a Hypothetical Case from All Sides: DOJ, SEC, and CCO

Jeffrey H. Knox, Esq.
Partner, Simpson Thacher; Former Chief, Fraud Section, Criminal Division, US Department of Justice, Washington, DC






Cheryl J. Scarboro, Esq.
Partner, Simpson Thacher; Former Chief, FCPA Unit, US Securities and Exchange Commission, Washington, DC






Ashley Watson, Esq.
Senior Vice President, Chief Ethics & Compliance Officer, Merck & Co, Inc.; Former Counsel, Chief Ethics and Compliance Officer, Hewlett-Packard, Philadelphia, PA






Gary Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., Washington, DC (Moderator)










5:45 p.m.



Adjournment and Networking Reception




Go to Agenda:
Day 2 | Day 3




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