 | ||
 |
 |
|
|
| ||
|
|
|
| |
|
| |||
|
|
Wednesday, October 20, 2010 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. |
|
Compliance Overview: Laws and Regulations, the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, the Federal Sentencing Guidelines, and Important Settlements with the Government Wendy C. Goldstein, Esq. Member of the Firm, Epstein Becker & Green PC, New York, NY (Co chair) Presentation Material (Acrobat) |
| |
|
|
9:00 a.m. |
|
FDA Regulatory Overview: Trends Affecting the Regulation of Advertising and Promotion, the FDA Review Process and Requirements for Claim Support, Fair Balance, and DTC Promotion Lucy Rose, MBA President, Lucy Rose and Associates, Former Director, Office of Training and Communications, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Roseland, VA (Co chair) Permission to post presentation not granted |
| |
|
|
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 (Co chair) Presentation Material (Acrobat) |
| |
|
|
11:15 a.m. |
|
Interactive Group Discussion of Hypothetical Scenarios |
| |
|
|
11:45 a.m. |
|
Questions and Comments |
| |
|
|
12:00 p.m. |
|
Adjournment and Lunch on Your Own |
| |
|
|
PRECONFERENCE II |
|
INTERNET AND SOCIAL NETWORKING COMMUNICATION UPDATE |
| |
|
|
8:00 a.m. |
|
Welcome and Introduction Natasha Nelson Former Executive Director, Ethics and Compliance, Novartis Pharmaceuticals, Former Executive Director, Chief Ethics and Compliance Officer, Daiichi-Sankyo, New York, NY (Co chair) |
| |
|
|
8:15 a.m. |
|
Overview: The Current State of FDA Regulation and Enforcement Relating to the Internet and Social Media Vernessa T. Pollard, Esq. Counsel, Arnold & Porter LLP, Former Associate Chief Counsel, Food and Drug Administration, Washington, DC Presentation Material (Acrobat) |
| |
|
|
9:00 a.m. |
|
Addressing Internet and Social Networking Communications in Your Compliance Program Natasha Nelson Former Executive Director, Ethics and Compliance, Novartis Pharmaceuticals, Former Executive Director, Chief Ethics and Compliance Officer, Daiichi-Sankyo, New York, NY Presentation Material (Acrobat) |
| |
|
|
9:45 a.m. |
|
Dos and Don'ts in Addressing Online Communications--Good and Bad--About Your Products and Company Meredith Manning, Esq. Partner, Hogan Lovells US LLP, Former Assistant US Attorney, Civil Division, US Attorney's OfficeFormer Associate Chief Counsel, Food and Drug Administration, Washington, DC Presentation Material (Acrobat) |
| |
|
|
10:30 a.m. |
|
Break |
| |
|
|
11:00 a.m. |
|
Establishing a Social Media Monitoring Program Maxim Duprat Director, Pharmaceutical & Life Sciences Practice, PricewaterhouseCoopers LLP, Florham Park, NJ Presentation Material (Acrobat) |
| |
|
|
11:30 a.m. |
|
Faculty Q&A |
| |
|
|
12:00 p.m. |
|
Adjournment and Lunch on Your Own |
| |
|
| ||
|
|
DAY I: Government Enforcement Wednesday, October 20, 2010 |
|
|
| ||
|
|
1:00 p.m. |
|
Welcome and Introduction Colleen M. Craven Vice President, Corporate Compliance & Business Practices, Endo Pharmaceuticals, Chadds Ford, PA (Co chair) |
| |
|
|
1:15 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) |
| |
|
|
2:00 p.m. |
|
Keynote: DoJ 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 |
| |
|
|
2:45 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) |
| |
|
|
3:30 p.m. |
|
Break |
| |
|
|
4:00 p.m. |
|
Keynote: FTC Enforcement Update Richard A. Feinstein, Esq. Director, Bureau of Competition, Federal Trade Commission, Former Supervisor, Antitrust Division, US Department of Justice, Washington, DC |
| |
|
|
4:30 p.m. |
|
Setting the Stage: PCF Pharmaceutical Compliance Professional and Legal Counsel Roundtable Douglas M. Lankler, Esq. Senior Vice President, Chief Compliance Officer, Pfizer, New York, NY Michael L. Shaw Vice President & Compliance Officer, GlaxoSmithKline-NA Pharmaceuticals, Former Senior Counsel, Office of Inspector General, Philadelphia, PA Doreen F. Shulman Vice President, Chief Compliance and Ethics Officer, Bristol-Myers Squibb, Princeton, NJ Caroline West, Esq. Senior Vice President Chief Compliance Officer, Shire Pharmaceuticals, Wayne, PA Brian Riewerts Partner, Global Pharmaceuticals and Life Sciences, PricewaterhouseCoopers LLP, Baltimore, MD (Moderator) |
| |
|
|
5:45 p.m. |
|
Adjournment and Networking Reception |
|
|
| |||
|
|
|
| |
|
| |||
© Health Care Conference Administrators
Contact Webmaster