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OVERVIEW
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ABOUT THE PHARMA CONGRESS
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Through the International Pharma Congress, the Pharmaceutical Compliance Forum seeks to offer a collaborative forum for the development of best practices in global pharmaceutical compliance programs. The Congress brings together global pharmaceutical regulators, compliance professionals, legal counsel, senior executives and industry observers to identify the major global compliance challenges of the day and to discuss approaches to practical and effective compliance.
The Congress focuses on the comparative analysis of national and international regulatory schemes and serves as a conclave where companies can share their approaches to the development and implementation of effective multi-jurisdictional compliance programs.
The 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 Congress will offer preconference sessions on:
- Preconference I: Global Compliance Program Operational Issues: Infrastructure, Monitoring, Auditing and Managing with Limited Resources
- Preconference II: Comparing, Contrasting and Complying with the Various Global Codes of Conduct
- Preconference III: Advanced Issues in Promotion, Inducements and Corrupt Practices, including Foreign Corrupt Practices Act
- Preconference IV: An Overview of the United State Regulatory Environment (FDA and Healthcare) for Global Pharmaceutical Compliance Professionals
And will feature tracks with multiple facilitated interactive sessions on:
- Track I: Promotion, Inducements and Corrupt Practices, including Foreign Corrupt Practices Act
- Track II: Pharmacovigilance and Drug Safety
- Track III: International Clinical Trials
- Track IV: Practical Case Studies: Third Party Oversight, Distribution Channel Challenges and Management of Allegations and Investigations
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.
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WHO SHOULD ATTEND
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- Pharmaceutical Manufacturers
- Generic Pharmaceutical Manufacturers
- Site Management Organizations
- Clinical Research Organizations
- Management Companies
- Wholesale, Retail, Mail Order and Internet Pharmacies
- Health Care Regulators and Policy Makers
- Pharmaceutical and Health Care Executives and Board Members
- Regulatory and Compliance Professionals
- Medical Directors
- Physicians
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- Pharmacists
- Food and Drug Law Attorneys
- Health Care Attorneys and In-house Counsel
- Compliance Officers
- Privacy Officers
- Ethics Officers and Corporate Social Responsibility Personnel
- Pharmaceutical Consultants
- Investment Bankers
- Venture Capitalists
- Health Services Researchers and Academics
- Auditors
- Promotion Signatories/Approvers
- Risk Management Personnel
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THE CONGRESS GOALS AND OBJECTIVES
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- To assemble a forum for leading regulators, enforcement experts and industry observers to express views and concerns in order to enhance communication among actors in the compliance field.
- To utilize plenary panel discussions as a means of assessing pharmaceutical regulatory and compliance risks and sharing best practice responses.
- To offer a series of facilitated, interactive track sessions on key fraud, drug safety and pharmacovigilance, and international clinical trial issues.
- To compare and contrast the various pharmaceutical global codes of conduct and assess approaches to multi code-compliance.
- To assess global compliance program operational issues, including infrastructure, monitoring, auditing and managing with limited resources.
- To share current hot topics in sales and marketing compliance in Africa, Asia, Europe, Latin America and Middle East.
- To identify and discuss advanced issues in promotion, inducements and corrupt practices, including Foreign Corrupt Practices Act.
- To describe and analyze the European Commission’s December 5, 2007 proposal to re-design existing European drug safety rules.
- To analyze which guidelines apply to international congresses, including booth materials, non-CME medical presentations, and interactions between commercial associates and health care professionals.
- To offer an overview of the United States regulatory environment (FDA and Healthcare) for global pharmaceutical compliance professionals.
- To identify global enforcement and compliance issues and corresponding compliance controls and solutions.
- To describe company best practices through policy exchange and discussion.
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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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