"We have tried to make this conference different - more interactive, creative and worthwhile."
- PCF Planning Committee

The leadership of the Pharmaceutical Compliance Forum (PCF), the sponsor of the Ninth Annual Pharmaceutical Regulatory and Compliance Congress, seeks to transform the event to reflect a new style of learning and knowledge exchange. To that end, the PCF special planning committee has created the following special aspects of the Pharma Congress agenda:

1. The Pharma Congress will feature a series of special sessions on these following crucial regulatory and compliance issues:
   • Sales and Marketing Compliance Update,
   • Research, Development and Clinical Trials Compliance Update,
   • The "411" on Government Price Reporting: What Every Compliance Professional Needs to Know,
   • Relationships with Healthcare Professionals Compliance Update,
   • Emerging Compliance Challenges,
   • Pharmacovigilance and Drug Safety Compliance Update,
   • Working with Third Parties, Vendors and Strategic Partners,
   • Creating an Environment for Productive Post-Settlement Interactions with the Government: CIAs, DOJ Monitors and Disclosures, and
   • FCPA Compliance Update
   
   
2. The Pharma Congress will feature a special case study track on the following topics:
   • Interactive International Case Studies Covering a Range of Topics to Include: Distribution Channel Challenges; Third Party Oversight (Including Use of HCPs as Third Parties, and Anti-bribery and Anticorruption Considerations); Organization of International Congresses and Conferences for HCP Attendance; and Management of Allegations and Investigations, and
   • Interactive Domestic Case Studies Covering a Range of Topics to Include: Speaker Management Issues; In-Office Interactions; Conflicts of Interest Between Sales Reps and Customers; Firewall Issues Between Vendors who Provide Medical and Marketing Publication Services for the same Pharma Company; PhRMA Code Issues Prior to Implementation; and PhRMA Code issues that are not Crystal Clear
   
   
3. The Pharma Congress will be interactive. In the plenary sessions each attendee will have a Meridia Audience response device with which he or she will be able to vote on questions put by the faculty. The attendee responses will be immediately projected on the session screens.
   
   
4. The Pharma Congress will feature two unique networking reception opportunities. The Monday evening networking reception will provide an opportunity to meet a number of key federal and state regulators and Capitol Hill staff specializing in pharmaceutical policy. Tuesday evening will feature a company Best Practices Compliance Policy and Procedure Poster Board and Exchange Reception throughout the Pharma Congress Exhibit Hall.
   
   
5. The Pharma Congress will feature an extraordinary series of keynote speakers.

• Pharmaceutical and Health Care Executives and Board Members
• Compliance Executives
• Health Plan, Health System and Physician Organizations
• Medical Directors
• Physicians
• Pharmacists and Pharmacy Technicians
• Purchasers, including Private Employers and Public Purchasers
• Pharmaceutical Manufacturers
• Generic Pharmaceutical Manufacturers
• Site Management Organizations
• Clinical Research Organizations
• Pharmacy Benefit

• Management Companies
• Nurses
• Health Plans and Health Insurers
• Wholesale, Retail, Mail Order and Internet Pharmacies
• Health Care Attorneys and In-house Counsel
• Compliance Officers
• Privacy Officers
• Ethics Officers
• Food and Drug Law Attorneys
• Pharmaceutical Consultants
• Investment Bankers
• Venture Capitalists
• Health Care Regulators and Policy Makers
• Health Services Researchers and Academics
• Auditors

• List the role of the states in regulatory pharmaceutical enterprises.
• Explain in what ways big pharmaceutical companies should change in the future.
• Analyze and assess emerging regulatory and compliance issues.
• Describe ways to control risks, solve problems, and manage compliance within the regulatory guidelines.

The Pharmaceutical Compliance Forum (PCF) is a coalition of senior compliance officials and legal counsel from more than 50 of the largest pharmaceutical manufacturers. The PCF was founded in early-1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compliance programs. The organization is open to others in the industry and has more than doubled in membership since its founding. The members meet twice a year, for one to two days, focusing on open and informal sharing of compliance information, best practices, and current developments in the field. For membership information, contact Colleen Lacey at 215-599-6617 or via email at info@PharmaComplianceForum.org.

The leadership of the Pharmaceutical Compliance Forum (PCF), the sponsor of the Eighth Annual Pharmaceutical Regulatory and Compliance Congress, seeks to transform the event to reflect a new style of learning and knowledge exchange. To that end a PCF special planning committee has been charged with the transformation of the Pharma Congress.

• Sujata T. Dayal, Esq., Ethics and Compliance Officer, Pharmaceutical Products Group, Abbott Laboratories (Co chair)
• Lori Queisser, Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation (Co chair)
• Arjun Rajaratnam, Vice President & Compliance Officer, US Pharmaceuticals, GlaxoSmithKline (Co chair)
• Bert Weinstein, Esq., Vice President, Corporate Compliance, Purdue Pharma LP (Co chair)
• Ted Acosta, Esq., Principal, Ernst & Young LLP
• Scott Bass, Esq., Partner, Sidley Austin LLP
• John T. Bentivoglio, Esq., Partner, King & Spalding LLP
• Kathleen Boozang, Esq., Associate Dean for Academic Affairs, Cofounder, Health Law & Policy Program, and Health Law, Science and Technology Graduate Programs, Seton Hall Law School
• Robert P. Brady, Esq., Partner, Hogan & Hartson LLP
• David B. Chandler, PhD, DABT, Director of Outcomes and Analysis, Corporate Compliance, Amgen
• Colleen Craven, Vice President, Ethics and Corporate Compliance, Endo Pharmaceuticals
• David Davidovic, Senior Director, Business Practices, Genentech, Inc.

• William T. Fitzgerald, Vice President, Global Compliance, Alcon Laboratories
• Wendy C. Goldstein, Esq., Partner, Epstein Becker & Green
• Peter N. Grant, JD, PhD, President, Health Care Conference Administrators, LLC
• Stephen Kanovsky, US Corporate Compliance Officer, Sanofi-Aventis US, Inc.
• Keith M. Korenchuk, JD, MPH, Of Counsel, Covington & Burling LLP
• Daniel A. Kracov, Esq., Partner, Arnold & Porter
• Steve Mohr, Esq., Global Compliance Officer, AstraZeneca
• Brian Riewerts, Partner, Global Pharmaceutical Advisory Services Group, PricewaterhouseCoopers LLP
• Sue Seferian, Esq., Senior Counsel, Johnson & Johnson
• Paul J. Silver, Managing Director, National Life Sciences Practice, Huron Consulting Group
• Jonathan K. Sprole, Vice President, Deputy General Counsel and Chief Compliance Officer, Bristol-Myers Squibb Company
• Caroline West, Esq., Senior Vice President, Chief Compliance and Risk Officer, Shire Pharmaceuticals, Inc.