Over the past few years, the pharmaceutical industry has come under increased regulatory 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 government's enforcement efforts have focused on health care providers. Increasingly, the pharmaceutical sector is becoming the subject of healthcare enforcement and prosecution initiatives. Now pharmaceutical companies are seeking to respond to the Compliance Guidance for the Pharmaceutical Industry issued by the Office of Inspector General. 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 Pharmaceutical Congress 2003 (the Congress) has been established in response to the issuance of the Compliance Guidance for the Pharmaceutical Industry by the Office of Inspector General and 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 November 12 through 14, 2003 in Washington, DC at the Renaissance Washington DC Hotel. 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.

The Congress is sponsored by the Pharmaceutical Compliance Forum (PCF). 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 one to two days, focusing on open and informal sharing of compliance information, best practices, and current developments in the field.

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

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.

At the conclusion of the Congress, attendees should be able to:

• 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.