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




DISCLOSURE SUMMIT AGENDA: PRECONFERENCE
Tuesday, February 19, 2013


7:00 am Registration Commences

PRECONFERENCE: SUNSHINE ACT, DOMESTIC AND GLOBAL AGGREGATE SPEND AND DISCLOSURE 101
8:00 am Welcome & Introductions

Danielle M. Drissel, Esq.
Associate, Hogan Lovells US LLP, Washington, DC (Co chair)

Jack T. Tanselle
Managing Director, Navigant Consulting, Inc., Indianapolis, IN (Co chair)
8:15 am Overview of the Physician Payment Transparency Provisions of the Affordable Care Act

Danielle M. Drissel, Esq.
Associate, Hogan Lovells US LLP, Washington, DC
Presentation Material (Acrobat)
9:00 am State Transparency Reporting Requirements; The Affordable Care Act Preemption Provision

Ronald L. Wisor, Jr., Esq.
Partner, Hogan Lovells US LLP, Washington, DC
Presentation Material (Acrobat)
9:45 am Break
10:00 am Compliance Strategies in Response to and Operational Implications of State and Federal Aggregate Spend and Disclosure Regulations

Gus Papandrikos
Director Transparency Operations, sanofi-aventis, New York, NY

Jack T. Tanselle
Managing Director, Navigant Consulting, Inc., Indianapolis, IN
Presentation Material (Acrobat)
10:45 am Overview of International Transparency Requirements and Creating a Compliant Global Aggregate Spend and Disclosure Program

Jae Burnett
Senior Manager, Deloitte & Touche LLP, Costa Mesa, CA

Sally Foroughi
Senior Manager, Deloitte & Touche LLP, Costa Mesa, 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 Pharmaceuticals, Philadelphia, PA
11:30 am Faculty Q&A
12:00 pm Preconference Adjournment and Lunch on Your Own


AGENDA: DAY I
Tuesday, February 19, 2013


OPENING PLENARY SESSION: THE US REGULATORY SETTING OVERVIEW
1:00 pm

Welcome and Overview

Trudy J. Seeley
Senior Manager, Transparency Operations, Sanofi US, Bridgewater, NJ (Co chair)
1:15 pm

The Sunshine Regulations

Niall Brennan
Director, Office of Information Products and Data Analytics, Centers for Medicare and Medicaid Services, Washington, DC
Presentation Material (Acrobat)
2:15 pm

Where We are in Disclosure and Aggregate Spend Implementation With or Without a Final Sunshine Rule

Katrina S. Cahill
Senior Manager, Global Transparency Lead, Biogen Idec, Weston, MA
Rore Middleton, Esq.
Senior Manager, Corporate Compliance, Purdue Pharma LP, Stamford, CT
Trudy J. Seeley
Senior Manager, Transparency Operations, Sanofi US, Bridgewater, NJ
David Wysocky
Director, Pharmaceutical and Life Sciences Advisory Services, PricewaterhouseCoopers, Florham Park, NJ (Moderator)
Presentation Material (Acrobat)
3:00 pm Break
3:30 pm

Disclosure Enforcement Update: The Government Perspective

David Hart, Esq.
Senior Assistant Attorney General, Oregon Department of Justice, Salem, OR
Marilyn May, Esq.
Deputy Chief for Affirmative Litigation, US Attorney's Office, Eastern District of Pennsylvania, United States Department of Justice, Philadelphia, PA
Virginia "Ginny" A. Gibson, Esq.
Partner, Hogan Lovells US LLP; Former Executive Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA (Moderator)
Presentation Material (Acrobat)
4:15 pm

An Update on State Laws and Regulations

Natasha F. Thoren, JD, LLM
Associate, Pharmaceutical Industry Health Regulatory Practice Group, Epstein Becker & Green, New York, NY
Presentation Material (Acrobat)
4:45 pm

Responding to Federal and State Investigations and Enforcement Actions

Michael K. Loucks, Esq.
Partner, Skadden Arps LLP; Former First Assistant US Attorney, US Attorney's Office for the District of Massachusetts, Washington, DC
Presentation Material (Acrobat)
5:15 pm

Perspective: The Implications of the Sunshine Rule for Physicians

Jeremy A. Lazarus, MD
Board Certified Psychiatrist; President, American Medical Association, Denver, CO
5:45 pm

Perspective: The Implications of the Sunshine Rule for the Pharmaceutical and Medical Device Industries

David J. Rothman, PhD
Director, Center for the Study of Society and Medicine; Bernard Schoenberg Professor of Social Medicine, College of Physicians and Surgeons, Columbia University; President, Institute on Medicine as a Profession, New York, NY
Presentation Material (Acrobat)
6:15 pm Adjournment and Networking Reception




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




© Health Care Conference Administrators
Contact Webmaster