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    Preconference Symposia - Wednesday, November 7, 2007





    7:00 a.m.



Congress Registration



    8:30 a.m.



Preconferences Commence; Choose one only




Preconference I



Compliance Program Basics: Monitoring, Auditing, Training






(Session will be interactive and participants will receive a toolkit at the end of this session with Compliance Program basics for training, monitoring and auditing.)


8:00 a.m.




Overview: Why Training, Monitoring and Auditing are the Critical Components of an Effective Compliance Program



8:45 a.m.




Training: OIG Compliance Program Guidance for Pharmaceutical Manufacturers; Establishing a Training Curriculum; Types of Training; and Keeping Training Relevant



9:30 a.m.




Monitoring: OIG Compliance Program Guidance for Pharmaceutical Manufacturers; Using Corporate Integrity Agreements and Other Sources to Establish a Monitoring Plan Based on Your Company's Risks; Considerations for Investigating Findings and How to Conduct such an Investigation; and Evaluation of Necessary Corrective Action (e.g., Training, Communication, Policy Enhancements)



10:15 a.m.



Break



10:45 a.m.



Auditing: OIG Compliance Program Guidance for Pharmaceutical Manufacturers; Using Corporate Integrity Agreements and Other Sources to Establish an Audit Plan Based on Your Company's Risks; Establishing an Audit Plan; and Conducting Audits and Discussion of Relevant Considerations (e.g., Communication Plans, Privilege Considerations, Reporting Findings, Investigating Findings, Corrective Action)



11:30 a.m.



Comments, Questions and Answers



12:00 p.m.




Adjournment and Lunch on Your Own



Preconference II



Payment/Reimbursement/Reporting Update




8:00 a.m.



Introductory Comments
  • William A. Sarraille, Esq., Partner, Sidley Austin LLP, Washington, DC (Co chair)
  • Sue Seferian, Esq., Senior Counsel, Johnson & Johnson, New Brunswick, NJ (Co chair)



8:05 a.m.



A Short History of Pricing Related Fraud and Abuse Issues



8:50 a.m.



Recent Pricing Fraud and Abuse Litigation Developments - Some Perspective on the Boston AWP Case and the FDB Settlement



9:40 a.m.



Fraud and Abuse Issues in Part D Pricing and Contracting



10:10 a.m.



Break



10:25 a.m.



Recent Pricing and Coverage Issues and Their Fraud and Abuse Implications - The Final AMP and Best Price Rule; The OPPS Rule for 2008; The Physician Fee Schedule for 2008; Clinical Trial Coverage under the Medicare Program; and The Pending CHAMP Legislation, including Proposed Changes to Part D Coverage



12:00 p.m.




Adjournment and Lunch on Your Own



Preconference III



Global Compliance Update







  • Ted Acosta, Esq., Principal, Ernst & Young LLP, New York, NY (Co chair)
  • Sujata T. Dayal, Esq., Ethics and Compliance Officer, Pharmaceutical Products Group, Abbott Laboratories, Abbott Park, IL (Co chair)
  • Andrew Hayward, Esq., Senior Counsel, AstraZeneca, London, UK
    Presentation Material (Acrobat)
    Presentation Material (Powerpoint)



8:00 a.m.



Organizing and Operating a Global Compliance Program - Resources, Reporting, Scope, International Codes and Local Standards



8:45 a.m.



Rolling Out Policies, Training and Compliance Guidance in the Global Setting



9:30 a.m.



Key Issues in Global Compliance - Relationships with Physicians/Customers, CME, Donations, Post-Market, Third-Party Arrangements



10:15 a.m.



Break



10:45 a.m.



Incorporating FCPA Compliance into Program Operations



11:30 a.m.



Comments, Questions and Answers



12:00 p.m.




Adjournment and Lunch on Your Own



Preconference IV



Risk Avoidance Writing for Pharmaceutical Companies: Secrets for Avoiding Liability and Creating Accurate, Powerful Documents in Regulated Industries




8:00 a.m.



In this interactive session, attendees will learn:
  • 4 types of information never to include in documents
  • 7 ways poorly written documents can come back to haunt you
  • 6 tips for grabbing your reader's attention
  • 10 techniques for keeping your reader's eyes glued to the page
  • 5 tricks to improve your proofreading skills by 95%
  • 9 grammatical secrets to avoid errors that even educated people make. Plus...take home 4 Bonus items:
    • Memo Template for requests to management that will save hours of time
    • Email Template to ensure your emails get read and acted upon
    • Proofreading Handout with tips and symbols to share at work
    • Grammar Cheat-Sheet for easy, confident reference
Linda Rivero, President, Voice of Persuasion, Alexandria, VA
Nancy Singer, President of Compliance-Alliance; Former Prosecutor, U.S. Department of Justice, Washington, DC



12:00 p.m.




Adjournment and Lunch on Your Own




    Day I: Perspectives on the Pharmaceutical Sector in Changing Times
   Wednesday, November 7, 2007






1:00 p.m.





Welcome and Annual State of the Pharmaceutical Compliance Enterprise Address

Lori Queisser
Senior Vice President, Global Compliance and Business Practices
Schering-Plough Corporation
Kenilworth, NJ
(Co chair)



1:30 p.m.





The Regulatory Craft: Controlling Risks, Solving Problems, and Managing Compliance

Malcolm Sparrow, MPA, PhD
Professor of Practice of Public Management and Faculty Chair
Executive Program on Strategic Management of Regulatory and Enforcement Agencies
Kennedy School of Government, Harvard University
Author, The Regulatory Craft: Controlling Risks, Solving Problems, and Managing Compliance
and License to Steal: How Fraud Bleeds America's Health Care System
Cambridge, MA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Handout Material (Acrobat)



2:15 p.m.





How Big Pharma Should Change

Peter Lurie, MD, MPH
Deputy Director
Public Citizen's Health Research Group
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Handout Material (Acrobat)
Handout Material (Microsoft Word)



3:00 p.m.



Break




3:30 p.m.




OIG Update

Lewis Morris, Esq.
Chief Counsel, Office of Inspector General
Department of Health and Human Services
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



4:30 p.m.




The Role of States in Regulating the Pharmaceutical Enterprise

James G. Sheehan, Esq.
Medicaid Inspector General, State of New York
Former Associate United States Attorney, U.S. Attorney's Office
Eastern District of Pennsylvania
Albany, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



5:15 p.m.




State Attorney General Roundtable

Jim Donahue, Esq.
Pennsylvania Chief Deputy Attorney General, Antitrust
Pennsylvania Office of the Attorney General
Harrisburg, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

John Guthrie, Esq.
Director, Medicaid Fraud Control Unit
Ohio Office of Attorney General
Columbus, OH

David Hart, Esq.
Assistant Attorney General, Consumer Protection
Oregon Office of the Attorney General
Salem, OR

John Krayniak, Esq.
Assistant Attorney General and Senior Counsel
Medicaid Fraud Control Unit
New Jersey Office of the Attorney General
Trenton, NJ

Pat Lupinetti, Esq. (Invited)
Assistant Attorney General, Medicaid Fraud Control Unit
New York Office of Attorney General
Albany, NY

Susan J. Miller
Managing Attorney, Antitrust & Civil Medicaid Fraud Division
Texas Office of the Attorney General
Austin, TX

Kathleen M. Boozang, Esq.
Associate Dean and Professor of Law
Cofounder, Health Law & Policy Program
and Health Law, Science and Technology Graduate Programs
Seton Hall University School of Law
Newark, NJ
(Moderator)



6:30 p.m.




Adjournment and Meet the Regulators Networking Reception

The Pharma Congress Wednesday networking reception will offer an opportunity to meet a number of key federal and state regulators and Capitol Hill staff specializing in pharmaceutical policy.




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