Event Date/Time: Sep 29, 2005 End Date/Time: Sep 30, 2005
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In this unsettled, high-risk and high-stakes environment, counsel, executives and safety officers for the pharmaceutical industry must have an in-depth and complete understanding of the latest legal, regulatory, legislative and political developments affecting drug safety today. The 2005 Drug Safety Congress will give you the latest information from your colleagues who are on the forefront of the current safety protocol controversy, as well as the reform movement. An outstanding faculty of leading attorneys, in-house counsel, safety officers, and industry and government representatives will provide insights on:

How will the proposals of the Grassley Dodd bill impact existing drug safety practices?
- what powers would a new Center for Postmarket Drug Evaluation and Research have?
- what approach would an Enzi bill take?
Who and what are the latest focus of recent Congressional hearings concerning drug safety?
What constitutes a "safe" pharmaceutical product?
How will the FDA's Final Risk Minimization Guidance impact your company's business plan?
- how will safety practices differ for accelerated approvals and fast-tracked drugs?
How do you establish an effective risk management plan?
How will the Drug Safety Oversight Board enhance the FDA's existing review and oversight of pharmaceutical products?
What will the IOM's findings on drug safety reveal about the current U.S. drug safety system
When will the FDA's "Drug Watch" Website launch and how will its contents affect your business practices?
What other FDA safety initiatives are in the works?
How will new safety regulations data impact product liability risk and product recall?
How can the U.S. and E.U. achieve safety harmonization?
Plus, add value to your attendance by taking advantage of our Master Class on Establishing a Proactive Adverse Events Monitoring System. This in-depth workshop will provide practical and tactical advice on the elements of effective signal detection, data analysis as well as the legal issues surrounding adverse events.


2401 M Street NW
United States