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



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   Monday, November 3, 2014
   Preconference Symposia (Optional; Choose one)






7:30 a.m.



Congress Registration Opens










    8:30 a.m.



Preconferences Commence (Choose one)




PRECONFERENCE I



ADVANCED ISSUES IN DOMESTIC AND GLOBAL TRANSPARENCY: AGGREGATE SPEND, DISCLOSURE, SUNSHINE ACT, AND R&D AND MEDICAL AFFAIRS TRANSPARENCY




8:30 a.m.




Introduction, Panel Discussion and Q&A

John Patrick Oroho, Esq.
Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ (Moderator)






Kelly N. "Nikki" Reeves, MPA, JD
Partner, King & Spalding LLP; Legal Counsel, Ad Hoc Sunshine and State Law Compliance Group, Washington, DC (Moderator)










9:15 a.m.




Domestic Commercial Transparency: Disclosure, Aggregate Spend and Sunshine

Kate Farrington
Associate Director, Aggregate Spend, Forest Laboratories, New York, NY










9:45 a.m.




Global Transparency

Anthony Brennan
Senior Director, HCC Governance, Metrics and Reporting, Johnson & Johnson, New York, NY






Katrina Cahill
Global Transparency Lead, Biogen Idec, Cambridge, MA






David Wysocky, MBA
Partner, PwC, New York, NY










10:30 a.m.




Break










10:45 a.m.




Global Transparency (Continued)










11:30 a.m.




R&D and Medical Affairs Transparency

Karen D. Green
R&D Health Care Compliance Officer, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ






Seth Whitelaw, JD, LLM, SJD
Director, Life Sciences Regulatory Compliance Practice, Deloitte & Touche LLP; Former R&D Compliance Officer, GlaxoSmithKline; Former Legal Compliance Officer, SmithKline Beecham, Philadelphia, PA






Mary Bradley, PharmD
Healthcare Compliance Officer, Johnson & Johnson, Philadelphia, PA (Moderator)










12:00 p.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE II



INNOVATIONS IN AUDITING AND MONITORING







  • The Use of Risk Assessments to Guide Audit Planning and Ensuring Alignment with the Business
  • Compliance Auditing Best Practice
    • Drivers for Continued Focus on Compliance Auditing -- Data Collection, Analysis and Reporting, etc.
    • Compliance Audit Focus Areas -- Where are We Seeing the Highest Risks?
    • Strategies for Conducting Effective Risk-Based Control Audits
    • Legal Considerations -- When Should an Audit be Privileged, if Ever?
  • Compliance Monitoring Best Practices
    • Drivers for Continued Focus on Compliance Monitoring -- CIA's, Commercial, R&D, etc.
    • Types of Monitoring -- Physical, Electronic, Risk-Based Targeting and Scoring Process
    • Strategies for Identifying Trends in Monitoring Results
  • Maintaining Appropriate Stakeholder Awareness of Compliance Risk through Effective Reporting
  • Panel/Audience Discussion on Different Approaches, Perspectives and Practices
  • A Look to the Future: What's Needed, What's Wanted, and What Do We Need to Get There in the Next 2-5 Years?



8:30 a.m.




Welcome and Introduction

BJ D'Avella, MBA
Director, Huron Consulting Group, New York, NY






Jae Burnett
Director of Compliance, Masimo, Los Angeles, CA






Eve Costopoulos
Vice President, Chief Ethics and Compliance Officer, Eisai Inc., Woodcliff Lake, NJ






Erik Eglite, MBA, JD, DPM
Vice President, Chief Compliance Officer and Corporate Counsel, Lundbeck Pharmaceuticals, Chicago, IL






Dan Dalton, MBA, JD
Senior Vice President, Chief Compliance Officer, Salix Pharmaceuticals, Raleigh, NC






Darren R. Jones
Director, Polaris, New York, NY






Jeffrey Klimaski
Vice President, Corporate Ethics and Compliance Officer, BTG International Inc., Philadelphia, PA






Paul J. Silver
Practice Leader and Managing Director, Huron Consulting Group, Atlanta, GA






L. Stephan Vincze, LD, LLM, MBA
Partner, Polaris; Former Senior Vice President, Chief Compliance Officer, Warner Chilcott; Former Vice President, Ethics and Compliance Officer/Privacy Officer, TAP Pharmaceutical Products Inc., Boston, MA (Moderator)










12:00 p.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE III



ADVANCED ISSUES AND BEST PRACTICES IN INVESTIGATIONS







  • Internal Investigations
    • Best Practices in Conducting Internal Investigations
    • Issues Related to Voluntary Disclosure
    • Attorney-Client Privilege
    • How to Conduct Internal Investigation Cross Examinations
    • Coordination with HR, Legal and Business
  • Responding to Government Investigations
    • Best Practices in Responding to Government Investigations
    • Search Warrant
    • Grand Jury Subpoena



8:30 a.m.




Welcome and Introduction

Sarah K. diFrancesca, Esq.
Associate, Health Care and Life Sciences Regulatory Group, Cooley, LLP, New York, NY






Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY






Elizabeth J. Gorman, Esq.
Vice President, Legal Commercial, Acorda Therapeutics, Inc., Ardsley, NY






Liz Lewis, Esq.
Chief Counsel and Chief Compliance Officer and Head, Patient Advocacy, Takeda Pharmaceuticals International Co/Millennium: The Takeda Oncology Company, Boston, MA






Michael K. Loucks, Esq.
Partner, Skadden Arps LLP; Former Acting United States Attorney, US Attorney's Office for the District of Massachusetts, Washington, DC (Moderator)










12:00 p.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE IV



GLOBAL COMPLIANCE ISSUES AND PROGRAMS







  • Implementing a Global Compliance Program: Practical Operational Challenges and Issues
  • Sponsorship of HCPs: Understanding the New Landscape
  • Negotiating, Managing, Auditing and Monitoring Third Party Relationships
  • Global HCP/KOL Engagement Management
  • Developing Effective Strategies for Working with the Business
  • Medical/Commercial Boundaries in the Global Context



8:30 a.m.




Welcome and Introduction

Yogesh Bahl, CPA, MBA
Managing Director, AlixPartners, New York, NY






Rachel Batykefer, CCEP
Associate Director, Compliance, Teva Pharmaceuticals; Former Manager, Compliance Education, Tyco International, Philadelphia, PA






Michael D. Bell, Esq.
President, R-Squared, Princeton, NJ






Paul Curtin, Esq.
Compliance Officer - Global Research and Development, Actavis; Former Head of Compliance - Ex-US, Forest Laboratories, New York, NY






David Hodgson, CPA
Partner, Deloitte & Touche LLP, New York, NY






Kirt Kraeuter, MGA
Head of Compliance, European Markets, Australia/New Zealand, and Canada, Bristol-Myers Squibb, Philadelphia, PA






Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC (Moderator)










12:00 p.m.




Preconference Adjournment; Lunch on your Own




    DAY I
    Monday, November 3, 2014









COMPLIANCE OFFICER ROUNDTABLE AND GOVERNMENT ENFORCEMENT




1:00 p.m.




Welcome and Introduction

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






Margaret K. Feltz
Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT (Co-chair)






Kelly B. Freeman, PhD
Senior Director, Ethics and Compliance, Eli Lilly and Company, Indianapolis, IN (Co-chair)






Elizabeth V. Jobes, Esq.
Senior Vice President, Chief Compliance Officer, Auxilium Pharmaceuticals Inc., Philadelphia, PA (Co-chair)










1:30 p.m.




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










2:15 p.m.




US DOJ Update (Faculty to be announced)

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






Michael K. Loucks, Esq.
Partner, Skadden Arps LLP; Former Acting United States Attorney, US Attorney's Office for the District of Massachusetts, Washington, DC (Co-moderator)










3:00 p.m.




FDA/OPDP Update

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










3:30 p.m.



Break










4:00 p.m.




Compliance Officer Roundtable

Regina Gore Cavaliere, Esq.
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Princeton, NJ






Sujata Dayal
Vice President Health Care Compliance and Privacy, Pharmaceuticals, Johnson & Johnson; Former Global Chief Compliance Officer and Corporate Vice President, Biomet, Inc.; Former Member, PCF Executive Committee, Chicago, IL






Laurie D'Alessio
Vice President, Global Compliance Organization, Merck & Co., Inc., Whitehouse Station, NJ






Michael L. Shaw, Esq.
Vice President and Compliance Officer, GlaxoSmithKline-NA Pharmaceuticals; Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services; Former Member, PCF Executive Committee, Philadelphia, PA






Kris Curry
Principal, Fraud Investigation and Dispute Services, Ernst & Young LLP; Former Vice President, Health Care Compliance, Pharmaceuticals Group, Johnson & Johnson, Philadelphia, PA (Moderator)










5:00 p.m.



Adjournment and Networking Reception




Overview | Agenda | Continuing Education | Promotional Opportunities | Grantors & Exhibitors | Travel/Hotel
Registration | Speaking Proposals | Admininstration | Webcast Log In | Past Conferences | Contact Us | Home




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