national disclosure summit on Pharmaceutical and Medical Device Disclosure, Transparency and Aggregate Spend Conference



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national pharmaceutical and medical device disclosure and transparency conference

FOURTH ANNUAL SUMMIT ON DISCLOSURE, TRANSPARENCY AND AGGREGATE SPEND FOR DRUG, DEVICE AND BIOTECH COMPANIES

March 26 - 28, 2012

Onsite:
Renaissance Hotel, Washington, DC


Online:
Live and Archived for 6 Months

MEDIA PARTNERS

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EARLY BIRD REGISTRATION
- SAVE UP TO $200 -
Register by Friday, February 17, 2012 for Early Bird discount and save up to $200.
Click here to register.

SPECIAL PCF MEMBER REGISTRATION RATE
- SAVE UP TO $800 -

Click here to register.

BROCHURE NOW AVAILABLE
Click here to download brochure.

PROPOSED SUNSHINE RULE ISSUED
Click here to review the proposed Sunshine rule.

KEYNOTE ADDRESSES
On the Proposed CMS Sunshine Rule:

Niall Brennan, MPP
Acting Director, Policy and Data Analysis Group, Centers for Medicare and Medicaid Services, Washington, DC

On the Role of the OIG:

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

FEATURING PRECONFERENCE ON SUNSHINE ACT, AGGREGATE SPEND AND DISCLOSURE 101
PLENARY SESSIONS ON
  • The Continuing Role of Congress in Sunshine Act Implementation
  • Drug Samples, the Next Horizon?
  • Inconsistencies between the Sunshine Act, Anti-Kickback, and Medicare and Medicaid Reporting Obligations
  • Lessons Learned from Going Live: Experience of the First Quarter under Sunshine
  • After Sunshine: Deal with the Consequences of Public Disclosures
  • Where Disclosure Meets Enforcement
  • Aggregate Spend Awareness: Physician Survey Results and Case Study
  • Educating Physicians about the Sunshine Law
  • Panel on Global Transparency
  • Coordination of Sunshine Act and Global Disclosure and Transparency Initiatives
  • Case Study: Purdue Aggregate Spend Approach and Solutions
  • Case Study: Sanofi-Aventis Aggregate Spend Approach and Solutions
  • THE FOLLOWING MINI SUMMITS
  • Key Operations Considerations
  • Technology Solutions
  • Sunshine Compliance for Medical Device Companies
  • Research & Development Compliance
  • AND A CLOSING ADVANCED ISSUES BEST
    PRACTICE WORKSHOP




    FOURTH ANNUAL SUMMIT ON DISCLOSURE, TRANSPARENCY AND
    AGGREGATE SPEND FOR DRUG, DEVICE AND BIOTECH COMPANIES

    A Pharma Congress Conference
    March 26 - 28, 2012

    ONSITE
    Renaissance Hotel
    Washington, DC


    OR
    ONLINE
    In your own office or home live via the Internet
    with 24/7 access for six months


    CO CHAIRS

    Karen Lowney
    Senior Director, Compliance, Teva Pharmaceuticals, Frazer, PA

    Katherine E. Norris, MPA
    Director, Corporate Compliance, The Spectranetics Corporation, Colorado Springs, CO

    Trudy J. Seeley
    Senior Manager, Transparency Operations, Sanofi US, Bridgewater, NJ

    Wendy Tsuei, MBA
    Associate Director, State and Federal Reporting, Corporate Ethics and Compliance, Eisai Inc., Woodcliff Lake, NJ
    FEATURED FACULTY

    Danielle Bacco
    Manager, Corporate Compliance, Purdue Pharma LP, Stamford, CT

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




    Jean Bicknell
    Consultant, Regulatory Law, Baxter Healthcare, Deerfield, IL

    Christine N. Bradshaw, Esq.
    Director, Regulatory and Compliance Services, Porzio Pharmaceutical Services, Associate, Porzio, Bromberg & Newman, Morristown, NJ

    William E. Buzzeo, MS
    Vice President and General Manager Compliance Solutions Division, Cegedim Relationship Management, Richmond, VA

    Ben Carmel
    Manager, Polaris Management Partners, New York, NY

    Louise Cashman
    Senior Manager, HCP Reporting and Analysis, Boston Scientific Corporation, Boston, MA

    Jennifer Colapietro
    Partner, Transparency and Aggregate Spend Practice Lead, PricewaterhouseCoopers LLP, Florham Park, NJ

    Meenakshi Datta, Esq.
    Partner, Sidley Austin LLP, Chicago, IL

    Marc Eigner, MS, MBA
    Partner, Polaris Management Partners, New York, NY

    Mark Farrar
    Associate Director, Navigant Consulting, Atlanta, GA

    Virginia "Ginny" A. Gibson, Esq.
    Partner, Hogan Lovells US LLP, Former Executive Assistant US Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA

    Sarah K. Giesting, Esq.
    Associate, Pharmaceutical Industry Health Regulatory Practice Group, Epstein Becker & Green, New York, NY

    Jeffrey L. Handwerker, Esq.
    Partner, Arnold & Porter, Washington, DC

    Jonathon Kellerman
    Principal, Pharmaceutical and Life Sciences Advisory Services, PricewaterhouseCoopers LLP, Florham Park, NJ

    John B. Knighton, Esq.
    Director and Interim Chief Compliance Officer, Wright Medical Technology, Inc., Arlington, TN

    Keith M. Korenchuk, JD, MPH
    Partner, Arnold & Porter, Washington, DC

    Daniel A. Kracov, Esq.
    Partner and Chair, FDA and Healthcare Practice, Arnold & Porter, Washington, DC

    Mark Linver
    Managing Director, Life Sciences Advisory Services Practice, Huron Consulting Group, LLC, New York, NY

    Seth H. Lundy, Esq.
    Partner and Deputy Chair, FDA and Life Sciences Practice Group, King & Spalding LLP, Washington, DC

    Marilyn May, Esq.
    Senior Litigation Counsel, US Attorney's Office, Eastern District of Pennsylvania, United States Department of Justice, Philadelphia, PA


    Kate Whelley McCabe, Esq.
    Assistant Attorney General, Public Protection Division, Vermont Office of the Attorney General, Montpelier, VT

    Jack Mitchell
    Chief of Oversight and Investigations, Special Committee on Aging, United States Senate, Former Director, Commissioner's Office of Special Investigations, US Food and Drug Administration, Washington, DC

    MaryAnn Northrup, MSN
    Associate Director, Navigant Consulting, Indianapolis, IN



    Laura O'Donnell, Esq.
    Chief Compliance Counsel, GE Healthcare, Wauwatosa, WI

    John Patrick Oroho, Esq.
    Executive Vice President, Porzio Pharmaceutical Services Principal, Porzio, Bromberg & Newman PC, Morristown, NJ

    Amy Papranec, MBA
    Vice President, Transparency, Stryker, Mahwah, NJ

    Suj Patel
    Director, Life Sciences Practice, Huron Consulting Group, New York, NY

    Tina Posey
    Associate Director, Sample Compliance, Takeda Pharmaceuticals North America, Inc., Deerfield, IL

    Marjorie E. Powell, Esq.
    Senior Assistant General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, DC

    Kelly N. (Nikki) Reeves, Esq.
    Partner, King & Spalding, Washington, DC

    Tim Robinson, Esq.
    President, The Regulatory Law Group, PLLC, Executive Vice President & General Counsel, MMIS, Inc., New York, NY

    Mark Scallon, MHA
    Partner, Polaris Management Partners, New York, NY

    Jack T. Tanselle
    Managing Director, Navigant Consulting, Inc., Indianapolis, IN

    Manny Tzavlakis
    Managing Director, Life Sciences Practice, Huron Consulting Group, New York, NY

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



    Julie Wind
    Director - Physician Payment Reporting, Eli Lilly and Company, Indianapolis, IN

    Kim Zahan, MBA
    Director R&D Financial Compliance, GlaxoSmithKline, King of Prussia, PA
    ATTENDANCE OPTIONS
    TRADITIONAL CONFERENCE ATTENDANCE
    By attending onsite, you will be able to more completely immerse in the subject matter, get professional networking opportunities, and interact with the faculty. Register for Preconference and/or Conference.

    LIVE AND ARCHIVED INTERNET ATTENDANCE
    Watch the conference plenary session in live streaming video and listen to streaming audio of track sessions over the Internet and at your convenience at any time 24/7 for the six months following the event.

    The archived conference includes speaker videos and coordinated PowerPoint presentations.

    Pros: Live digital feed and 24/7 Internet access for next six months; Accessible in office, at home or anywhere worldwide with Internet access; Avoid travel expense and hassle; No time away from the office

    INTERNET INTERFACE SAMPLE

    Click here for a sample stream





    SAVE THE DATE
    SIXTH INTERNATIONAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS AND BEST PRACTICES FORUM
    A Hybrid Conference and Internet Event
    May 14 - 16, 2012
    Hilton Budapest
    Budapest, Hungary
    www.InternationalPharmaCongress.com

    SECOND ASIA PACIFIC PHARMACEUTICAL COMPLIANCE CONGRESS
    A Hybrid Conference and Internet Event
    Sponsored by Pharmaceutical Compliance Forum and Asia Pacific Healthcare Industry Compliance Team
    September 11 - 13, 2012
    Intercontinental Shanghai Pudong Hotel
    Shanghai, China
    www.AsianPharmaCongress.com

    FIRST LATIN AMERICAN PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS
    A Hybrid Conference and Internet Event
    Sponsored by Pharmaceutical Compliance Forum and Latin American Ethics and Compliance Network
    October 2 - 4, 2012
    Hilton Sao Paolo Morumba
    Sao Paulo, Brazil
    www.LatinAmericanPharmaCongress.com

    THIRTEENTH PHARMACEUTICAL REGULATORY
    AND COMPLIANCE CONGRESS

    Sponsored by Pharmaceutical Compliance Forum
    November 5 - 7, 2012
    Grand Hyatt
    Washington, DC
    www.PharmaCongress.com


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    THE THIRD NATIONAL DISCLOSURE SUMMIT CONTENT IS NOW AVAILABLE
    IN VARIOUS POST CONFERENCE FORMATS

    The Third National Disclosure Summit conference content is now available in a variety of formats.

    You may purchase the Summit streaming content in the following formats: Flash Drive or online archive (6 months). You may also purchase individual presentations in an online archive (6 months) format.

    YOU CAN PURCHASE JUST THE THIRD NATIONAL DISCLOSURE SUMMIT CONTENT AS FOLLOWS:

    Online Archive of 2011 Third National Disclosure Summit Presentations today!
    Complete conference: $595
    Order Now

    Flash Drive of 2011 Third National Disclosure Summit Presentations today!
    $595
    Order Now

    FINALLY YOU MAY PURCHASE THE THIRD NATIONAL DISCLOSURE SUMMIT INDIVIDUAL PRESENTATIONS:
    Click here to purchase individual presentations for $59.95 in online archive format (6 months of access - 24/7).




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