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Colloquium Overview

The Issue:

There are no issues more critical in today's pharmaceutical industry than those related to medical affairs, clinical trials, safety and publications. Today the pharmaceutical industry has come under increased regulatory scrutiny by federal and state governments as well as the plaintiff 's bar related to these four areas. The U.S. Government and the FDA have begun to more rigorously enforce the rules and regulations that apply to the pharmaceutical industry. Until recently, the majority of the government's enforcement efforts have focused on sales and marketing practices in the pharmaceutical industry. Increasingly, the pharmaceutical sector is becoming the subject of healthcare enforcement and prosecution initiatives on issues ranging from drug safety, conduct of clinical trials and publication of scientific and clinical data. Pharmaceutical companies are being forced to update their knowledge of existing laws and incorporate them into their business plans as well as create future business plans that comply with the often ambiguous and confusing rules and regulations. Not only will these issues be discussed at this important Summit, but participants will learn practical tips and compliance strategies.

The Summit:

The International Pharmaceutical Compliance Summit on Medical Affairs, Clinical Trials, Safety and Publication (the Summit) has been established in response to the heightened need for corporate compliance programs, increased government scrutiny and new regulations being imposed upon the pharmaceutical industry. It will bring together the nation's leaders in the pharmaceutical industry. This three-day conference, sponsored by PhRMA, the Pharmaceutical Compliance Forum, Health Affairs, the Harvard Health Policy Review, and many leading publications will take place March 30 through April 1, 2005 in Philadelphia at the Inn at Penn. Pharmaceutical professionals looking for a comprehensive understanding of the current and future compliance laws and regulations and enforcement initiatives affecting the pharmaceutical industry should plan to attend.

Written Materials:

The Faculty of the Summit will prepare written materials to accompany their presentations, including copies of presentation overheads, slides and related materials that will be included with the Summit materials.

Who Should Attend:
  • Pharmaceutical and Health Care Executives and Board Members
  • Healthcare Compliance Professionals
  • Health Plan, Health System and Physician Organization
  • Medical Directors
  • Physicians
  • Pharmacists
  • Purchasers, including Private Employers and Public Purchasers
  • Pharmaceutical Manufacturers
  • Generic Pharmaceutical Manufacturers
  • Site Management Organizations
  • Clinical Research Organizations
  • Pharmacy Benefit
  • 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
  • Health Care Auditors

Summit Goals & Objectives
  • To Discuss the Regulators' Enforcement Initiatives Pertaining to the Pharmaceutical Industry
  • To Articulate Practical Tips about Implementing Compliance Programs in Pharmaceutical Companies
  • To Suggest Appropriate Steps to be Taken if a Government Investigation is Initiated
  • To Relate to Case Studies that Demonstrate how Multinational Corporations Expanded their Compliance Programs to International Operations
  • To Provide an Overview of the Final OIG Compliance Program Guidance for Pharmaceutical Manufacturers
  • To Discuss the Specific Impact on Compliance Program Organization and Structure as a Result of the OIG's Compliance Guidance
  • To Review the Identified Risk Areas in the Compliance Guidance and the Potential Impact on the Pharmaceutical Industry
  • To Analyze New and Existing Compliance Obligations for Pharmaceutical Manufacturers
  • To Explore Practical Initiatives Your Company can Pursue to Implement Provisions of the OIG Compliance Guidance
  • To Explain how Clinical Trials Should be Conducted and Build Controls to Mitigate Potential Risk
  • To Explain the FDA Labeling and Advertising Requirements and How to Build Compliance Programs around those Requirements
  • To Analyze Legal Obstacles Associated with Promoting Drugs on the Internet and to Develop Responsive Strategies
  • To Learn Drug Sample Regulations and Develop Strategies for Dealing with them
  • To Assess the Applicability of HIPAA to the Pharmaceutical Industry and Suggest Compliance Strategies
  • To Set Forth the Do's and Don'ts of Government Pharmaceutical Pricing Regulation and Suggest Necessary Controls to Bill Medicare and Medicaid

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