PharmaCongress: Agenda: Day 2

Pre-Conference/
Day One

Day Two

Day Three

Agenda: Day 2 Thursday, November 13, 2003
8:00 a.m.	Welcome and Introduction to Day Two Douglas M. Lankler, Esq. Senior Corporate Counsel Deputy Compliance Officer Pfizer Inc. New York, NY (Conference Co chair)
8:15 a.m.	CMS Payment Policies for Pharmaceuticals Thomas A. Scully Administrator, Center for Medicare and Medicaid Services Department of Health and Human Services Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
9:00 a.m.	Antitrust and the Pharmaceutical Sector Thomas B. Leary, Esq. Commissioner, Federal Trade Commission Washington, DC
9:30 a.m.	The FDA Regulation of Drug Promotion Thomas L. Abrams Director, Division of Drug Marketing Advertising & Communications U.S. Food and Drug Administration Rockville, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
10:15 a.m.	An Analyst's View of the Implications of Regulatory Compliance to Value David Moskowitz, MBA, R.PH Senior Vice President and Healthcare Senior Analyst Friedman, Billings, Ramsey Group, Inc. Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
10:45 a.m.	Break
11:00 a.m.	CONCURRENT SESSIONS I
	1.01 Advertising, Sales, Marketing, and Promotion: Integrating Compliance Into the Commercial Practices Kathleen A. Knight, Esq. Vice President, Deputy General Counsel and Assistant Secretary Alcon Laboratories, Inc. Fort Worth, TX Catherine A. Sazdanoff Divisional Vice President Ethics and Compliance Abbott Laboratories Abbott Park, IL Presentation Material (Acrobat) Presentation Material (Powerpoint)
	1.02 Manufacturing and GMP Issues: GMPs Explained - A Primer on Developing a GMP Compliance Program Raymond A. Bonner, Esq. Partner, Sidley Austin Brown & Wood Washington, DC Nathan Sheers Partner, Sidley Austin Brown & Wood Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Response to Observation 1A (Acrobat) Response to Observation 1A (Microsoft Word) Response to Observation 1B (Acrobat) Response to Observation 1B (Microsoft Word) Response to Observation 3 (Acrobat) Response to Observation 3 (Microsoft Word) Response to Observation 4A (Acrobat) Response to Observation 4A (Microsoft Word) Response to Observation 4C (Acrobat) Response to Observation 4C (Microsoft Word) Response to Observation 5B (Acrobat) Response to Observation 5B (Microsoft Word)
	1.03 Research and Development: Learning which Regulatory Standards are Non-Standard Bert Spilker, PhD, MD, FCP, FFPM President, Bert Spilker & Associates Clinical Professor, Pharmacy Practice University of Minnesota Former Senior Vice President of Scientific and Regulatory Affairs PhRMA Bethesda, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
	1.04 Advanced Compliance Strategies: Conducting an Enterprise-Wide Risk Assessment Brian Riewerts Senior Manager, PricewaterhouseCoopers Baltimore, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
	1.05 Responding to Enforcement Initiatives: How to Manage an Internal Investigation Robert S. Litt, Esq. Partner, Arnold & Porter Former Principal Associate Deputy Attorney General United States Department of Justice Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Handout Material (Acrobat) Steve Sokolow Vice President and Head of Litigation Novartis Pharmaceuticals Corporation East Hanover, NJ
Noon	Networking Luncheon in the Exhibit Hall
1:00 p.m.	CONCURRENT SESSIONS II
	2.01 Advertising, Sales, Marketing, and Promotion: Implementing Controls around Grants, Consulting Agreements, CME and Preceptorships and other Promotional Practices Heidi Chen, Esq. Senior Corporate Counsel, Pfizer Inc. New York, NY Paul E. Kalb, MD, JD Partner, Sidley Austin Brown & Wood Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
	2.02 Manufacturing and GMP Issues: Preparing for an FDA Inspection Arthur N. Levine, Esq. Partner, Arnold & Porter Former Deputy Chief Counsel for Litigation Food and Drug Administration Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
	2.03 Research and Development: Managing Privacy in your Research and Development Enterprise Sujata T. Dayal, Esq. Division Ethics and Compliance Officer Pharmaceutical Products Division Abbott Laboratories Abbott Park, IL Justin McCarthy, Esq. Assistant General Counsel Global Research and Development, Pfizer Inc. New London, CT Presentation Material (Acrobat) Presentation Material (Powerpoint)
	2.04 Advanced Compliance Strategies: Corporate Governance and Corporate Compliance Richard P. Kusserow President, Strategic Management Systems, Inc. Former Inspector General Department of Health & Human Services Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Handout Material (Acrobat) Handout Material (Microsoft Word)
	2.05 Responding to Enforcement Initiatives: How to Negotiate and Live Under a Corporate Integrity Agreement Jonathon L. Kellerman Senior Manager PricewaterhouseCoopers Philadelphia, PA Presentation Material (Acrobat) Presentation Material (Powerpoint) L. Stephan Vincze, Esq. Ethics & Compliance Officer TAP Pharmaceuticals Lake Forest, IL Presentation Material (Acrobat) Presentation Material (Powerpoint)
2:00 p.m.	Transition Break
2:15 p.m.	CONCURRENT SESSIONS III
	3.01 Advertising, Sales, Marketing, and Promotion: Managing Privacy Risk in your Commercial Practices Allison J. Gassaro, Esq. Senior Attorney, NA Legal Aventis Pharmaceuticals Bridgewater, NJ Paul A. Sundberg, Esq. Staff Counsel, Commercial Legal Operations Takeda Pharmaceuticals North America, Inc. Lincolnshire, IL Presentation Material (Acrobat) Presentation Material (Powerpoint)
	3.02 Manufacturing and GMP Issues: Managing a Part 11 Compliance Initiative Pat Roche Partner, PricewaterhouseCoopers Florham Park, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint)
	3.03 Research and Development: Conducting a Clinical Risk Assessment and Implementing Compliance Practices Jane Stratton, Esq. Vice President Associate General Counsel And Chief Compliance Officer Chiron Corporation Emeryville, CA Presentation Material (Acrobat) Presentation Material (Powerpoint)
	3.04 Advanced Compliance Strategies: From Corporate Compliance to Enterprise Wide Risk Management Caroline H. West, Esq. Vice President, Global Legal Compliance Legal Compliance Group Aventis Pharmaceuticals Bridgewater, NJ Brian Riewerts Senior Manager PricewaterhouseCoopers Baltimore, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
	3.05 Responding to Enforcement Initiatives: Designing the Successor(s) to the Medicaid Rebate Program Edwin D. Rauzi, Esq. Partner, Davis Wright Tremaine Seattle, WA Presentation Material (Acrobat) Presentation Material (Powerpoint)
3:15 p.m.	Transition Break
3:30 p.m.	Afternoon Plenary Session Restoring Investor Confidence Dennis M. Nally Chairman and Senior Partner PricewaterhouseCoopers LLP New York, NY
4:00 p.m.	Regulating Pharmacy Benefit Managers (PBMs) James Sheehan, Esq. Chief of the Civil Division Assistant U.S. Attorney U.S. Attorney's Office for the Eastern District of Pennsylvania Philadelphia, PA Presentation Material (Acrobat) Presentation Material (Powerpoint)
4:45 p.m.	Progress in FDA's Drug Product Quality Initiative Janet Woodcock, MD Director, Center for Drug Evaluation and Research Food and Drug Administration Rockville, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
5:30 p.m.	Pharmaceutical Compliance Professionals Roundtable Tom Behan Compliance Director AstraZeneca Wilmington, DE Eve Costopoulos, Esq. Staff Vice President, Compliance Schering-Plough Corporation Law Department Kenilworth, NJ Douglas Lankler, Esq. Senior Corporate Counsel Deputy Compliance Officer Pfizer Inc. New York, NY Arjun Rajaratnam, Esq. Compliance Officer Global Pharmaceuticals, GlaxoSmithKline Research Triangle Park, NC L. Stephan Vincze, Esq. Ethics & Compliance Officer TAP Pharmaceuticals Lake Forest, IL Anthony L. Farino Partner, PricewaterhouseCoopers Chicago, IL (Moderator)
6:45 p.m.	Adjournment