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Overview
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The Issue
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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.
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The Summit
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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.
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Sponsoring Organizations
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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
www.hcca-info.org.
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 www.fdli.org.
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Extensive Written Materials
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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.
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Who Should Attend:
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Health Care Executives and Board Members
Health Plan, Health System and Physician Organization Medical Directors
Physicians
Pharmacists
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
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Summit Goals and Objectives
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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
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