PharmaCongress: Overview

Overview

The Issue

Over the past few years, the pharmaceutical industry has come under increased scrutiny by the federal and state governments as well as the plaintiff's bar. The U.S. Government, State Attorney Generals 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 govern-ment'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 rules and 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 congress.

The Congress

The Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum ("the Congress") 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 Pharmaceutical Compliance Forum will take place from November 13th through November 15th at the Philadelphia, PA Marriott. 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 Congress is sponsored by:
The Pharmaceutical Compliance Forum (PCF)
The Pharmaceutical Compliance Forum 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 one to two days, focusing on open and informal sharing of compliance information, best practices, and current developments in the field.

Featured Speakers Include:

Barrett Toan
President and Chief Executive Officer
Express Scripts, Inc.
St. Louis, MO

Fred Hassan
Chairman and Chief Executive Officer
Pharmacia Corporation
Chairman
Pharmaceutical Research & Manufacturers of America (PhRMA)
Peapack, NJ

Uwe E. Reinhardt, Ph.D.
James Madison Professor of Political Economy
Woodrow Wilson School
Princeton University
Princeton, NJ

Janet Rehnquist
Inspector General
Department of Health & Human Services
Washington, DC

Who Should Attend:

Pharmaceutical and Health Care Executives and Board Members
Compliance Executives
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

Extensive Written Materials

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

The Congress Goals and Objectives

At the conclusion of the Congress, 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