FDA Symposium - Symposium Overview

Symposium Overview

Rarely have there been so many major changes and uncertainties with such far-reaching consequences to drug development, manufacturing, monitoring and marketing. And rarely has there been a greater need to bring together representatives and advisors from government and the world's leading drugmakers to share strategies for regaining consumer confidence in today's medicines.

The FDA Regulatory and Compliance Symposium-a unique three-day, high-level forum in one of the world's most famous academic settings-will help drugmakers prepare for the full impact of all the changes flowing from the FDA and Congress, while clarifying many of the uncertainties. The Symposium will also provide practical, state-of-the-art solutions to the challenges of eliminating or reducing risks throughout the product life-cycle-from the drug pipeline to manufacturing to patient delivery.

Where:

The Symposium takes place on the campus of Harvard University. Classes are held in Annenberg Hall of the Sanders Theatre Complex. Inspired by the great halls of Oxford and Cambridge Universities, this room is arguably the most impressive space at Harvard. Harvard University, the oldest institution of higher learning in the United States, was established in 1636. Today, Harvard has grown to become a great undergraduate and graduate research university, with more than 18,000 degree candidates enrolled.

Who Should Attend:

Senior executives, compliance officers and managers of pharmaceutical companies, especially those responsible for the oversight of:

Regulatory affairs
Pharmacovigilance
Drug manufacturing
Quality management systems
Medical affairs
Clinical research
Risk management
Sales and marketing
Labeling
Legal affairs

Who Else Will Be There:

Meet and learn from top compliance and risk management experts from:

Actelion Pharmaceuticals
APCO Worldwide
Abbott Laboratories Ross Products Division
Allergan
Baxter Healthcare
Biogen Idec
Cambrex Bioscience
Covance Periapproval Services
EduQuest
Eli Lilly
Genzyme
Kendle
Louis A. Morris & Associates
Purdue Pharma
The Quantic Group
sanofi-aventis
TAP Pharmaceuticals
Wyeth Pharmaceuticals
...and more!

Learning Objectives:

To describe best industry practices for managing drug safety risks

To examine the latest changes at the FDA-including new people, policies and priorities-and prepare for more changes to come

To share ideas and discuss specific successful strategies for reducing risks throughout the life cycle of a product- from development to delivery, from bench to bedside

To reduce risks, improve quality and cut costs in manufacturing processes

To reduce risks and accelerate regulatory approvals in new product development

To reduce risks and minimize liabilities in product marketing and advertising

To meet heightened FDA expectations for pharmacovigilance

To implement proven techniques for internal compliance and risk auditing

To benchmark risk management strategies against several of the top pharmaceutical and biologic companies in the world

Symposium Sponsors:

FDAnews is the premier provider of global regulatory, legislative and business news and information for professionals in industries regulated by the U.S. Food and Drug Administra-tion and the European Commission. Pharmaceutical and medical device professionals rely on FDAnews' conferences, print and electronic newsletters, and books to stay in compliance with international standards and the FDA's complex and ever-changing regulations. For further information on FDAnews, visit www.FDANews.com.

The Harvard Health Policy Review, www.HHPR.org, is dedicated to broadening awareness of health policy issues. HHPR aims to educate people about healthcare policy and to stimulate thinking about the pressing health care questions facing the nation and the world. The HHPR is published by Exploring Policy in Health Care at Harvard (EPIHC), an organization of Harvard undergraduates whose main purpose is to encourage discussion of health policy issues on the Harvard campus. The HHPR is supported by the University-wide Interfaculty Initiative in Health Policy.

Health Affairs, www.HealthAffairs.org, is the leading journal of health policy thought and research. Health Affairs is a multidisciplinary journal covering a wide range of health issues. Topics covered include: access to care, health spending, quality, Medicare, Medicaid, prescription drug coverage and costs, physician practice, nursing trends, mental health, malpractice and health law, insurance reform, hospitals, global health, and disparities in health care, among others. Health Affairs is frequently cited by national media, including the The Washington Post, The New York Times, The Wall Street Journal, CNN, network television and radio, and National Public Radio. The January 12, 2005 The Washington Post cited Health Affairs as "the bible of health policy."

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