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OVERVIEW
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ABOUT THE PHARMA CONGRESS
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The Pharmaceutical Compliance Forum (PCF) and the Health Care Compliance Certification Program at Seton Hall Law School, sponsors of the International Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, seek to initiate a forum for the advancement of international compliance programs through a new style of learning and knowledge exchange. To that end, a special planning committee has been charged with creating the first International Congress and Best Practices Forum to take place in Europe. Under the leadership of the 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 international setting.
- The International Pharma Congress will feature a number of unique learning exercises, including Panels of Compliance Experts, former and current government officials and leaders in the compliance field.
- The International Pharma Congress will be interactive. It is a plenary session only meeting and attendees will be encouraged to join in discussions and ask questions.
- The International Pharma Congress will feature a unique networking reception opportunity. The Wednesday evening reception will feature a company Best Practice Policy and Procedure Poster Board and Exchange throughout the International Pharma Congress reception area.
- The International Pharma Congress will also feature key discussions on topics such as global enforcement trends, emerging compliance issues, drug safety and clinical trials.
- 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
- Medical Directors
- Physicians
- Pharmacists
- Pharmaceutical Manufacturers
- Generic Pharmaceutical Manufacturers
- Site Management Organizations
- Clinical Research Organizations
- Management Companies
- Food and Drug Law Attorneys
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- Wholesale, Retail, Mail Order and Internet Pharmacies
- Health Care Attorneys and In-house Counsel
- Compliance Officers
- Privacy Officers
- Ethics Officers
- 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 compute and analyze the results of the PCF International survey of pharmaceutical compliance practices.
- To utilize plenary panel discussions as a means of assessing pharmaceutical regulatory and compliance risks and sharing best practice responses.
- To describe company best practices through policy exchange and discussion.
- To identify global enforcement and compliance issues and corresponding compliance controls and solutions.
- To assemble a forum for leading regulators and enforcement experts to express views and concerns in order to enhance communication among actors in the compliance field.
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INTERNATIONAL PHARMA CONGRESS PLANNING COMMITTEE
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Ted Acosta
Principal, Ernst & Young LLP, New York, NY
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
Sujata Dayal
Ethics and Compliance Officer, Pharmaceutical Products Division, Abbott Laboratories, Abbott Park, IL
Susan E. Egan
Compliance Officer, Pharmaceuticals Europe, GlaxoSmithKline, London, UK
Gary Giampetruzzi, Esq.
Senior Corporate Counsel, Pfizer, Inc., New York, NY
Peter N. Grant, JD, PhD
PCF Educational Advisor, Seattle, WA
Linda Horton, Esq.
Partner, Hogan & Hartson LLP, Brussels, Belgium
Paul E. Kalb, JD, MD
Partner and Chair, National Health Care Group, Sidley Austin LLP, Washington, DC
Keith M. Korenchuk, JD, MPH
Partner, Covington & Burling LLP, Washington, DC
Karen Lowney
Senior Director, International Compliance, Schering Plough, Kenilworth, NJ |
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Dave O'Shaughnessy
Compliance Officer, Pharmaceuticals International, GlaxoSmithKline, London, UK
Lori Queisser
Senior Vice President, Global Compliance and Business Practices Schering-Plough Corporation, Kenilworth, NJ
Brian Riewerts
Partner, Life Sciences Advisory Group, PricewaterhouseCoopers LLP, Washington, DC
Jeff Rosenbaum
Senior Manager, PricewaterhouseCoopers LLP, London, UK
Brenton L. Saunders, JD, MBA
Senior Vice President and President Consumer Health Care., Schering-Plough Corporation, Past President, Health Care Compliance Association, Founder, International Association of Privacy Professionals, Kenilworth, NJ
Roeland van Aelst
Executive Director, Health Care Compliance, Europe, Middle East Africa, Johnson & Johnson, Brussels, Belgium
Paul Woods
Promotional Regulatory Director, AstraZeneca Pharmaceuticals, London, UK
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ABOUT THE SPONSORS
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Pharmaceutical Compliance Forum:
The International Pharma Congress is sponsored by the Pharmaceutical Compliance Forum (PCF), www.PharmaComplianceForum.org, a coalition of senior compliance professionals and legal counsel from more than 50 of the largest research-based 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 two days, focusing on open and informal sharing of compliance information, best practices, and current developments in the field, and sponsor a three-day compliance congress each Fall.
Health Care Compliance Certification Program of Seton Hall Law School:
The Health Care Compliance Certification Program is a multi-day educational program for compliance professionals and lawyers in the pharmaceutical and medical device industries that takes place at Seton Hall Law School in Newark, NJ. The Program addresses the issues faced by the pharmaceutical and device industries in complying with such standards as the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code, and the AdvaMed Revised Code of Ethics. The program immerses attendees in the statutes, regulations, and other guidance that comprise the body of law known as "fraud and abuse law," as well as FDA law, so they can understand the legal underpinnings of the compliance programs that they enforce.
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INTERNATIONAL PHARMA CONGRESS SPONSORS & GRANTORS
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GRANTORS:
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DIAMOND
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BRONZE
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PUBLICATION SPONSORS
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