Food and Drug Administration (FDA) Regulatory and Compliance Congress (FDA)

Venue: Harvard University

Location: Cambridge, Massachusetts, United States

Event Date/Time: Aug 23, 2006 End Date/Time: Aug 25, 2006
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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.

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
Drug manufacturing
Quality management systems
Medical affairs
Clinical research
Risk management
Sales and marketing
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
Baxter Healthcare
Biogen Idec
Cambrex Bioscience
Covance Periapproval Services
Eli Lilly
Louis A. Morris & Associates
Purdue Pharma
The Quantic Group
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