The Second Annual Pharmaceutical Industry Regulatory & Compliance Summit
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The Issue
Over the past few years, the pharmaceutical industry has come under increased scrutiny from the federal government. The US 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 health care providers. Now pharmaceutical companies are finding themselves under the gun. 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 federal regulations. Critical issues such as drug pricing, sales and marketing practice, conducting clinical trials and a proposed Medicare prescription drug benefit are many topics that will be discussed at this important summit.

The Summit
The Second Annual Pharmaceutical Industry Regulatory and Compliance Summit has been established as a direct result of 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 the Health Care Compliance Association in association with the Food and Drug Law Institute will be held June 10-12, 2001, at the Hyatt Regency Crystal City, Arlington, VA. 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.

Sponsoring Organizations
The Second Annual Pharmaceutical Industry Regulatory & Compliance Summit is sponsored by:
The Health Care Compliance Association (HCCA)
, the 501(c)(6) association representing approximately 2000 of the nation's healthcare chief compliance officers. HCCA offers a number of programs. For more information on HCCA, call 1-800-580-8373 or go to the HCCA website at

In Association with the:
Food and Drug Law Institute (FDLI)
is a non-profit institute dedicated to advancing the public health by providing a neutral forum for critical examinations of the laws, regulations, and policies related to drugs, medical devices, other healthcare technologies, and food. For more information call (800) 956-6293 or visit

Extensive 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:
Health Care Executives and Board Members
Health Plan, Health System and Physician Organization Medical Directors
Registered Nurses
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
Pharmaceutical Consultants
Investment Bankers
Venture Capitalists
Health Care Regulators and Policy Makers
Health Services Researchers and Academics

Summit Goals and Objectives
At the conclusion of the Summit, attendees should be able to:
  • Discuss the regulators' enforcement initiatives pertaining to the pharmaceutical industry.
  • Explain how clinical trials should be conducted and build controls to mitigate potential risk.
  • Relate to case studies that demonstrate how multinational corporations expanded their compliance programs to international operations.
  • Take appropriate steps if a government investigation is initiated.
  • Apply practical tips about implementing compliance programs in Pharmaceutical Companies.
  • Understand the FDA labeling and advertising requirements and build compliance programs around those requirements.
  • Appreciate the regulations and rules associated with government pricing of pharmaceuticals.
  • Understand legal obstacles associated with promoting drugs on the internet and develop strategies to deal with them.
  • Learn drug sample regulations and develop strategies for dealing with them.
  • Gain appreciation for applicability of HIPAA statute to the pharmaceutical industry and learn compliance strategies.
  • Learn the do's and don'ts of government pricing and develop necessary controls to bill medicaid.
Prerequisites: None

Overview | Agenda | Sponsors | Promotional Opportunities | Continuing Education
Registration | Travel/Hotel | Privacy Policy | Administration | Contact Us | Home