 | ||
 |
 |
|
|
| ||
|
|
|
| |
|
| |||
|
|
Wednesday, November 2, 2011 Preconference Symposia (Optional; Choose one) |
| |||
|
| |||||
|
|
7:00 a.m. |
|
Congress Registration |
| |
|
|
8:00 a.m. |
|
Preconferences Commence (Choose one) |
| |
|
|
PRECONFERENCE I |
|
COMPLIANCE BASICS |
| |
|
|
8:00 a.m. |
|
Welcome and Introductions Kelly B. Freeman, PhD Ethics and Compliance Officer, Eli Lilly and Company, Indianapolis, IN (Co chair) Sean P. Fahey, Esq. Partner, Pepper Hamilton LLP, Philadelphia, PA (Co chair) |
| |
|
|
8:15 a.m. |
|
The Legal Framework: Laws and Regulations, the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, the Federal Sentencing Guidelines, and Important Settlements with the Government Sean P. Fahey, Esq. Partner, Pepper Hamilton LLP, Philadelphia, PA Presentation Material (Acrobat) |
| |
|
|
10:00 a.m. |
|
Break |
| |
|
|
10:15 a.m. |
|
Implementing the Seven Elements of a Compliance Program: Practical Advice and Best Practices for Policy Development, Training, Communications, Monitoring, Auditing, and Corrective Actions Kelly B. Freeman, PhD Ethics and Compliance Officer, Eli Lilly and Company, Indianapolis, IN Presentation Material (Acrobat) |
| |
|
|
12:00 p.m. |
|
Preconference Adjournment and Lunch on your Own |
| |
|
|
PRECONFERENCE II |
|
PRACTICAL APPROACHES TO IMPLEMENTING AN AGGREGATE SPEND PROGRAM |
| |
|
|
8:00 a.m. |
|
Welcome and Introductions Eve M. Brunts, Esq. Partner, Ropes & Gray, Boston, MA (Co chair) Presentation Material (Acrobat) Melanie G. Nutt, JD, MPH Corporate Counsel, Genentech, Inc., South San Francisco, CA (Co chair) Kelly N. "Nikki" Reeves, MPA, JD Partner, King & Spalding LLP, Washington, DC (Co chair) |
| |
|
|
8:45 a.m. |
|
Practical Steps toward Complying with Sunshine Requirements -- Systems and Approaches to Aggregating Spend Michael McNeal Manager, Pharmaceutical & Life Sciences Advisory Practice, PricewaterhouseCoopers LLP, Denver, CO Presentation Material (Acrobat) |
| |
|
|
9:45 a.m. |
|
Break |
| |
|
|
10:00 a.m. |
|
Roundtable on Getting Ready for Sunshine: Helping You Assess Readiness Across: Melanie G. Nutt, JD, MPH Corporate Counsel, Genentech, Inc., South San Francisco, CA Presentation Material (Acrobat) Andrew M. Parks Director, Risk Consulting, KPMG LLP, Washington, DC Presentation Material (Acrobat) Suj Patel Director, Life Sciences Practice, Huron Consulting Group, New York, NY Presentation Material (Acrobat) Laura Sciarrino, Esq. Chief Legal Officer, Tercica, Inc., A Subsidiary of the Ipsen Group, Brisbane, CA Jack T. Tanselle Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Chicago, IL Presentation Material (Acrobat) |
| |
|
|
11:45 a.m. |
|
Wrap-up Eve M. Brunts, Esq. Partner, Ropes & Gray, Boston, MA (Co chair) Melanie G. Nutt, JD, MPH Corporate Counsel, Genentech, Inc., South San Francisco, CA (Co chair) Kelly N. "Nikki" Reeves, MPA, JD Partner, King & Spalding LLP, Washington, DC (Co chair) |
| |
|
|
12:00 p.m. |
|
Preconference Adjournment and Lunch on your Own |
| |
|
| ||
|
|
DAY I: Opening Plenary Session-Government Enforcement Wednesday, November 2, 2011 |
|
|
| ||
|
|
1:00 p.m. |
|
Welcome and Introduction Margaret K. Feltz, Esq. Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT (Co chair) Kelly B. Freeman, PhD Ethics and Compliance Officer, Eli Lilly and Company, Indianapolis, IN (Co chair) |
| |
|
|
1:15 p.m. |
|
Keynote John C. Lechleiter, PhD Chairman, President and Chief Executive Officer, Eli Lilly and Company, Chairman-elect, PhRMA Board of Directors, Indianapolis, IN |
| |
|
|
1:45 p.m. |
|
Keynote: OIG Update Mary E. Riordan, Esq. Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, US Department of Health and Human Services, Washington, DC Presentation Material (Acrobat) |
| |
|
|
2:30 p.m. |
|
Keynote: DOJ Civil Division Update Tony West, Esq. Head, Civil Division, US Department of Justice; Former California Special Assistant Attorney General; Former Assistant US Attorney, Northern California, Washington, DC |
| |
|
|
3:00 p.m. |
|
Break |
| |
|
|
3:30 p.m. |
|
Coordinating Pharma Prosecutions Michael Blume, Esq. Director, Office of Consumer Litigation, US Department of Justice, Washington, DC Joyce R. Branda, Esq. Director, Commercial Litigation Branch, US Department of Justice; Recipient, Presidential Meritorious Executive Award and Attorney General's Award for Exceptional Service, Washington, DC Virginia "Ginny" A. Gibson, Esq. Partner, Hogan Lovells US LLP; Former Executive Assistant US Attorney, Eastern District of Pennsylvania, Philadelphia, PA (Moderator) |
| |
|
|
4:15 p.m. |
|
Keynote: FDA-DDMAC Update Thomas W. Abrams, RPh, MBA Director, Division of Drug Marketing, Advertising, and Communications, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, MD Presentation Material (Acrobat) |
| |
|
|
4:45 p.m. |
|
Keynote Panel: Pharma 2020 - What Lies Ahead? Michael Dusseau Executive Director, Global Compliance, Merck & Co., Inc., New York, NY Keith Korenchuk, JD, MPH Partner, Arnold & Porter, Washington, DC Julie Kudyba Global Privacy Officer, Novartis Pharmaceuticals, Basel, Switzerland Brian Riewerts Partner & Global Life Sciences Compliance Practice Leader, PricewaterhouseCoopers LLP, Baltimore, MD (Moderator) Presentation Material (Acrobat) |
| |
|
|
5:30 p.m. |
|
Adjournment and Networking Reception and Best Practices Poster Board Session Kathryn A. Fillenwarth Advisor, LRL Ethics and Compliance, Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN (Poster Board Session Chair) |
|
|
| |||
|
|
|
| |
|
| |||
© Health Care Conference Administrators
Contact Webmaster