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 government's enforcement efforts have focused on health care providers. 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 Congress

The Pharmaceutical Congress 2003 ("the Congress") has been established as a direct result of the issuance of the Compliance Guidance for the Pharmaceutical Industry by the Office of Inspector General and 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 one-day conference, sponsored by the Pharmaceutical Compliance Forum will take place on June 8-9, 2003 in Washington, DC at the Omni Shoreham 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.

Sponsoring Organization

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.

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

Auditors

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

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