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



Overview | Agenda | Continuing Education | Promotional Opportunities | Grantors & Exhibitors
Speaking Proposals | Administration | Past Events | Webcast Log In | Contact Us | Home



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

The Sixth 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 SIXTH NATIONAL DISCLOSURE SUMMIT CONTENT AS FOLLOWS:

Online Archive of 2014 Sixth National Disclosure Summit Presentations today!
Complete conference: $595
Order Now

Flash Drive of 2014 Sixth National Disclosure Summit Presentations today!
$595
Order Now

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




national pharmaceutical and medical device disclosure and transparency conference

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

February 5 - 7, 2014

Attend Onsite:
Hyatt Regency Crystal City
Washington, DC

Webcast Participation:
Live and Archived
for 6 Months

KEYNOTE SPEAKERS




Toula Bellios
Director, Division of Policy and External Partnership, Center for Program Integrity, Data Sharing and Partnership Group, Baltimore, MD

Margaret (Peg) Hutchinson, Esq.
Assistant US Attorney, Civil Division, United States Attorney's Office, Eastern District of Pennsylvania, Philadelphia, PA




Roann Nichols, Esq.
Assistant US Attorney, United States Attorney's Office, District of Maryland, Baltimore, MD

Robert Patten, Esq.
Assistant Attorney General, Medicaid Fraud Division, The Commonwealth of Massachusetts, Co-chair, Global Case Committee, National Association of Medicaid Fraud Control Units, Holliston, MA
CHIEF COMPLIANCE OFFICER ROUNDTABLE

Christine Mikail, Esq.
Executive Vice President, General Counsel and Chief Compliance Officer, Dendron, New York, NY

Bert Weinstein, Esq.
Vice President, Corporate Compliance, Purdue Pharmaceuticals; Former Vice President and Assistant General Counsel, Merck, Stamford, CT

Caroline West, Esq.
Senior Vice President, Chief Compliance and Risk Officer, Shire Pharmaceuticals, Inc., Former Vice President, Global Legal Compliance, Aventis, Philadelphia, PA
FEATURED SESSION: SUNSHINE FOR MEDICAL DEVICE MANUFACTURERS

Kevin Dill, Esq.
Chief Compliance Officer, Olympus Corporation of the Americas, Philadelphia, PA

Nate Hwang, Esq.
Chief Compliance Officer, Zimmer, Inc., Fort Wayne, IN

Christopher L. White, Esq.
Senior Executive Vice President, General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC

Seth H. Lundy, Esq.
Partner, King & Spalding, Washington, DC (Moderator)
MINI SUMMITS
  • Technology Solutions
  • Practical Approaches to Global Transparency
  • Fair Market Value
  • Sunshine for Medical Device Manufacturers
  • Will Sunshine Data be Helpful to Whistleblowers and Qui Tam Attorneys?
CO-LOCATED WITH
TWENTY SECOND NATIONAL HIPAA SUMMIT
A Hybrid Conference and Internet Event
The Leading Forum on Healthcare EDI, Privacy, Breach Notification, Confidentiality, Data Security and HIPAA Compliance
Media Partners: Harvard Health Policy Review and Health Affairs
February 5 - 7, 2014, Hyatt Regency Crystal City, Washington, DC
www.HIPAASummit.com


AND PLENARY SESSIONS
  • Sunshine Act Implementation Update
  • Chief Compliance Officer Roundtable
  • March 31st Filing Deadline: The Top Six Steps to do to Prepare
  • Assumptions and Completing Context Boxes: To Do or not to Do; That is the Question
  • Managing the Dispute Resolution Process
  • Coordination of Compliance amongst Multiple Affiliates
  • Interaction and Coordination between State and Federal Reporting Requirements
  • Challenges and Best Practices in Reporting Clinical Spend
  • Transactions Reviews for Non-CIA Organizations
  • Protecting the Reputation and Relationships with Physicians and Teaching Hospitals
  • Global Challenge: Conducting Background Checks on the HCPs/HCOs
  • Roundtable on Global Transparency: A Country by Country Update
  • Best Practices in Implementing a Coordinated Global Transparency Program
ASSUMPTIONS AND COMPLETING CONTEXT BOXES

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




Angela Fifelski, Esq.
Corporate Counsel, Regulatory Law, Baxter Healthcare Corporation, Deerfield, IL
MANAGING THE DISPUTE RESOLUTION PROCESS




Julie Brubaker, Esq.
Compliance Officer, Biomet Warsaw Operations; Former Deputy Solicitor General, Indiana Attorney General, Warsaw, IN

Ronald L. Wisor, Jr., Esq.
Partner, Hogan Lovells US LLP, Washington, DC
INTERACTION AND COORDINATION BETWEEN STATE AND
FEDERAL REPORTING REQUIREMENTS

Diane E. Bieri, Esq.
Partner, Arnold & Porter, Former Executive Vice President and General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, DC

Trudy J. Seeley
Senior Manager, Transparency Operations, Sanofi US, Bridgewater, NJ
COORDINATION OF COMPLIANCE AMONGST MULTIPLE AFFILIATES




Erik Gross
President, NUI, Danville, CA

Jon Wilkenfeld, MBA
President, Potomac River Partners, Vienna, VA
TRANSACTIONS REVIEWS FOR NON-CIA ORGANIZATIONS

Gus Papandrikos, MBA
Director of Compliance, Daiichi Sankyo, Former Director Transparency Operations, sanofi-aventis, New York, NY

Jack T. Tanselle
Managing Director, Healthcare Dispute Compliance and Investigation Practice, Navigant Consulting, Inc., Indianapolis, IN
FAIR MARKET VALUE UPDATE

Eve M. Brunts, Esq.
Partner, Ropes and Gray, Boston, MA

Mark A. DeWyngaert, MBA, PhD
Managing Director, Huron Consulting Group, New York, NY (Moderator)
PROTECTING REPUTATION AND RELATIONSHIPS WITH
PHYSICIANS AND TEACHING HOSPITALS

Julia Galperin, Esq.
Director, Commercial Compliance Operations, Genentech, South San Francisco, CA

Andrew Rosenberg, Esq.
Co-Founder, Thorn Run Partners, Former Staff, Senate Health, Education, Labor and Pensions Committee, US Senate, Washington DC



Sylvia J. Trujillo, MPP, JD
Legislative Counsel, Senior Attorney, Legislative Counsel Division, American Medical Association; Former Litigation Attorney, Office of the General, Centers for Medicare and Medicaid Services, Washington, DC

Thomas Sullivan
President, Rockpointe Corporation, Editor, Policy and Medicine, Columbia, MD
TECHNOLOGY SOLUTIONS

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

Susan Hill
Senior Vice President, Business Development, AHM, Philadelphia, PA

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

Dean Rossi
Founder and President, Alanda, New Brunswick, NJ

Don Soong
Vice President of Strategic Solutions, Cegedim Relationship Management, Richmond, VA
GLOBAL CHALLENGE: CONDUCTING BACKGROUND CHECKS ON HCPs/HCOs

Ronny Arijs
Vice President Global Sustainability and Chief Compliance Officer, Grunenthal, Member, EFPIA Compliance Workgroup, Former Senior Compliance Manager, GE Healthcare, Brussels, Belgium

Geert Van Gansewinkel
Managing Director, Europe, Polaris, Amsterdam
CASE STUDY IN IMPLEMENTING A GLOBAL TRANSPARENCY SOLUTION

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

David Eiben
Director, IS Business Partnering, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
PRACTICAL APPROACHES TO GLOBAL TRANSPARENCY COMPLIANCE

Sujata Dayal, JD, LLM
Vice President Health Care Compliance and Privacy, Pharmaceuticals, Johnson & Johnson, Former, Global Chief Compliance Officer and Corporate Vice President, Biomet, Inc., Former Ethics and Compliance Officer - Pharmaceutical Products, Abbott Laboratories, Chicago, IL

Ashish Kalgaonkar, RPh, MBA
Senior Director, Global HCP Transparency Reporting, Eli Lilly and Company, Indianapolis, IN

Michael D. Petty, Esq.
Partner, King & Spalding LLP; Former Vice President of Development and Regulatory Law, Amgen Inc., Washington, DC

Carolyn Bruguera, Esq.
Vice President, Consulting Services and General Counsel, R-Squared; Former Vice President and General Counsel, Hansen Medical, Princeton, NJ (Moderator)
FEATURED FACULTY

Jonathan Bach
Partner, Cooley, LLP, New York, NY

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



Janice D. Kam, Esq.
Assistant General Counsel, Eisai Inc., New York, NY

Bharathram Lakshmivarahan
Director, Pharmaceutical & Life Sciences Advisory, PwC, Philadelphia, PA

Tom McCreadie
Sales Engineer, Compliance Solutions, Cegedim, Richmond, VA

Kelly N. "Nikki" Reeves, MPA, JD
Partner, King & Spalding LLP, Washington, DC

Rajiv Shah
Director, Pharmaceutical & Life Science Advisory Services, PwC, New York, NY



Annadoir (Anna) Staveley
Compliance Manager, Ethics, Quality & Compliance, Otsuka America Pharmaceutical Inc., Rockville, MD

Sarah Volden
Manager, Pharmaceutical & Life Science Advisory Services, PwC, Los Angeles, CA

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

Alexis Wong
Alexis Wong, Manager, Pharmaceutical & Life Science Advisory Services, PwC, Denver, CO

David Wysocky
Partner, PwC, Florham Park, NJ

SPECIAL PCF DISCOUNTS AVAILABLE
Special Pharmaceutical Compliance Forum (PCF) member registration discounts are available.
Click here to register.


UPDATED BROCHURE AVAILABLE
Click here to download brochure.
SPONSORED BY


CO CHAIRS

Margaret K. Feltz, Esq.
Director, Corporate Compliance, Purdue Pharma LP, Executive Committee, Pharmaceutical Compliance Forum, Stamford, CT

Ashish Kalgaonkar, RPh, MBA
Senior Director, Global HCP Transparency Reporting, Eli Lilly and Company, Indianapolis, IN

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

CONTINUING EDUCATION CREDITS
Compliance Professionals: Up to 23.4 Live CCB CEUs.

Accounting Professionals: Up to 24 NASBA CPE credits

Attorneys:
  • Approved to offer a maximum of 20.0 Hours of Texas CLE Credits.
  • Approved to offer a maximum of 13.0 Hours of Pennsylvania CLE Credits.
  • The Summit is currently pending approval to offer California MCLE Credit.

    Click here for more information.

  • TUITION SCHOLARSHIPS
    The Disclosure Summit supported by generous grants from the Heritage Provider Network is now offering partial and full Tuition Scholarships to qualifying representatives of local, state and federal government, consumer advocate organizations, safety net providers, academics, students and health services research organizations.
    Click here for more information.

    SUPPORTED BY

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    PARTICIPATION OPTIONS
    TRADITIONAL CONFERENCE ATTENDANCE
    Simply register, travel to the conference city and attend in person.

    Pros: subject matter immersion; professional networking opportunities; faculty interaction



    LIVE AND ARCHIVED WEBCAST ATTENDANCE
    Watch the conference in live streaming video 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



    WEBCAST INTERFACE SAMPLE

    Click here for a sample stream





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

    A Pharma Congress Conference
    February 5 - 7, 2014

    ATTEND ONSITE
    Hyatt Regency Crystal City
    Washington, DC


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



    SAVE THE DATES

    SEVENTH INTERNATIONAL PHARMACEUTICAL
    COMPLIANCE CONGRESS

    A Hybrid Conference and Internet Event
    Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)
    Cosponsored by Pharmaceutical Compliance Forum (PCF)
    May 5 - 7, 2014
    Conrad Dubai
    Dubai, United Arab Emirates
    www.InternationalPharmaCongress.com
    SECOND LATIN AMERICAN PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS
    A Hybrid Conference and Internet Event
    Sponsored by Latin American Ethics and Compliance Network
    Cosponsored by International Society of Healthcare Compliance Professionals (ETHICS) and Pharmaceutical Compliance Forum (PCF)
    July 28 - 31, 2014
    Mexico City, Mexico
    www.LatinAmericanPharmaCongress.com
    FOURTH ASIA PACIFIC PHARMACEUTICAL
    COMPLIANCE CONGRESS

    A Hybrid Conference and Internet Event
    Sponsored by Asia Pacific Healthcare Industry Compliance Team
    Cosponsored by International Society of Healthcare Ethics and Compliance Professionals (ETHICS) and Pharmaceutical Compliance Forum (PCF)
    September, 2014
    Beijing, China
    www.AsianPharmaCongress.com
    FIFTEENTH PHARMACEUTICAL REGULATORY
    AND COMPLIANCE CONGRESS

    A Hybrid Conference and Internet Event
    Transformational Learning - Effective Knowledge Exchange
    Sponsored by Pharmaceutical Compliance Forum
    November 3 - 5, 2014
    Hyatt Regency on Capitol Hill
    Washington, DC
    www.PharmaCongress.com



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

    The Fifth 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 FIFTH NATIONAL DISCLOSURE SUMMIT CONTENT AS FOLLOWS:

    Online Archive of 2013 Fifth National Disclosure Summit Presentations today!
    Complete conference: $595
    Order Now

    Flash Drive of 2013 Fifth National Disclosure Summit Presentations today!
    $595
    Order Now

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




    Overview | Agenda | Continuing Education | Promotional Opportunities | Grantors & Exhibitors
    Speaking Proposals | Administration | Past Events | Webcast Log In | Contact Us | Home




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