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Why This Conference Stands Out
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"We have tried to make this conference different - more interactive, creative and worthwhile."
- PCF Planning Committee
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The leadership of the Pharmaceutical Compliance Forum (PCF), the sponsor of the Seventh 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.
Under the leadership of the PCF special planning committee, the following initiatives have been put in place:
- The PCF with the help of PricewaterhouseCoopers is undertaking a survey of pharmaceutical compliance practices in the following areas: Medical Affairs and Marketing, Managing a Pharmaceutical Compliance Program, and Drug Safety and Pharmacovigilence. The results of the survey will be presented at the Pharma Congress and discussed by expert panels.
- The Pharma Congress will feature a number of unique learning exercises, including the Pharma Congress Hypothetical Compliance Vignettes and Response by Panel of Compliance Experts and the Pharmaceutical Compliance Family Feud-The Game with Real Life Implications for the Nation's Pharmaceutical Manufacturers.
- 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.
- The Pharma Congress will feature two unique networking reception opportunities. The Wednesday evening opening reception will feature a company Best Auditing, Monitoring and Investigations Policy and Procedure Poster Board and Exchange throughout the Pharma Congress Exhibit Hall. The Thursday evening networking reception will feature an opportunity to meet a number of key federal and state regulators and Capitol Hill staff specializing in pharmaceutical policy.
- At the Pharma Congress the PCF will award the First Annual Compliance Best Practice Awards. Categories of the awards in the large and small/medium sectors shall include the following in each sector: Best Practices in Training; Best Practices in Auditing/Monitoring; Best Practices in Communications; and Best Practices Overall.
- The Pharma Congress will feature an extraordinary series of keynote speakers.
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Who Should Attend
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- Pharmaceutical and Health Care Executives and Board Members
- Compliance Executives
- Health Plan, Health System and Physician Organizations
- Medical Directors
- Physicians
- Pharmacists
- Purchasers, including Private Employers and Public Purchasers
- Pharmaceutical Manufacturers
- Generic Pharmaceutical Manufacturers
- Site Management Organizations
- Clinical Research Organizations
- Pharmacy Benefit
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- Management Companies
- 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
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The Congress Goals and Objectives
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- To report and analyze the results of the PCF survey of pharmaceutical compliance practices in the following areas: medical affairs and marketing, drug safety and pharmacovigilence, and managing a pharmaceutical compliance program
- To utilize a hypothetical case studies and games as a means of assessing pharmaceutical regulatory and compliance risks and sharing best practice responses
- To freely exchange company best auditing, monitoring and investigations policies and procedures
- To identify and present awards to pharmaceutical companies in large and small/medium sectors as follows: Best Practices in Training; Best Practices in Auditing/Monitoring; Best Practices in Communications; and Best Practices Overall
- To provide a forum for leading regulators and qui tam counsel to express views and concerns in order to enhance communication among actors in the compliance field
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About the Pharmaceutical Compliance Forum
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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 Arjun Rajaratnam, Esq., Vice President and Compliance Officer, Global Pharmaceuticals, GlaxoSmithKline at 919-483-9938 or Arjun.X.Rajaratnam@gsk.com.
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PCF Special Planning Committee
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- Lori Queisser, Vice President and Chief Compliance Officer, Eli Lilly and Company (Co chair)
- Arjun Rajaratnam, Vice President and Compliance Officer, Global Pharmaceuticals, GlaxoSmithKline (Co chair)
- Brenton L. Saunders, JD, MBA, Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation (Co chair)
- Bert Weinstein, Esq., Vice President, Corporate Compliance, Purdue Pharma LP (Co chair)
- Ted Acosta, Principal, Ernst & Young LLP
- John Alivernini, Esq., Vice President and Chief Compliance Officer, Wyeth Pharmaceuticals
- David Beardsley, General Manager, Life Sciences, HCPro, Inc.
- John T. Bentivoglio, Esq., Partner, King & Spalding LLP
- David B. Chandler, Ph.D., DABT, Associate Director of Outcomes and Analysis Corporate Compliance, Amgen
- William T. Fitzgerald, Vice President, Global Compliance, Alcon Laboratories
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- Robert A. Freeman, US Compliance Officer and Compliance Counsel, Serono, Inc.
- Wendy C. Goldstein, Esq., Partner, Epstein Becker & Green
- Peter N. Grant, JD, Ph.D., President, Health Care Conference Administrators, LLC
- Keith M. Korenchuk, JD, MPH, Partner, Covington & Burling LLP
- Steve Mohr, Esq., Deputy Compliance Officer, AstraZeneca
- Jody Noon, RN, JD, National Leader for the Life Sciences & Health Care Regulatory Practice, Deloitte & Touche LLP
- Brian Riewerts, Partner, Global Pharmaceutical Advisory Services Group, PricewaterhouseCoopers LLP
- Catherine Sazdanoff, Divisional Vice President, Ethics and Compliance, Abbott Laboratories
- Michael Shaw, Deputy Compliance Officer, Novartis Pharmaceuticals Corporation
- Paul J. Silver, Managing Director, Life Sciences Leader, Huron Consulting Group
- Jonathan K. Sprole, Chief Compliance Officer, Bristol-Myers Squibb Company
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