Second Annual Risk Management and Drug Safety Summit

A Joint Presentation of FDAnews, United BioSource Corporation and the Center for Medicine in the Public Interest

(Washington, DC) – September 28, 2009 -- Join regulators and pharmaceutical industry experts on October 1st and 2nd at the National Press Club where they will discuss their new get-tough approach to risk management and drug safety regulation. The 2nd Annual Risk Management and Drug Safety Summit is a one and a half day-long conference and as a sponsor of the event, United BioSource Corporation invites reporters covering the FDA and the pharmaceutical industry to attend at no charge, any or all sessions.

For the full agenda, go to: http://www.fdanews.com/RMDS09Agenda<http://unitedbiosourcecorporation.cmail3.com/t/y/l/kktljt/kltlukeh/y> and to register, contact Jeff Grizzel at jgrizzel@fdanews.com

Thursday, Oct. 1st, 8:00am-5:30pm and Friday, October 2nd, 8am-11am

Speakers include:

Janet Woodcock, M.D., Director, CDER, FDA

Jane Axelrad, Associate Director for Policy, CDER, FDA

Sir Alasdair Breckenridge, Chairman, Medicines and Healthcare products Regulatory Agency, UK

Annette Stemhagen, Dr.P.H., FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United BioSource Corporation

Gerald Faich, M.D., M.P.H., FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United BioSource Corporation

Mark Ammann, Pharm.D., Vice President, Regulatory Affairs, United BioSource Corporation

Peter Pitts, President, Center for Medicine in the Public Interest

These and other industry experts will discuss:

How the agency is thinking about constituent communications

What “transparency” means and how the FDA will use the concept to change the way it does business

Whether “comparative effectiveness” will become the third leg of the drug approval process

The FDA in the Age of Obama

The key differences between U.S. and EU regulatory schemes and enforcement

What emerging standards could be used to assure all stakeholders are in agreement

How to use risk-benefit assessment throughout the product life cycle

About UBC UBC accelerates the generation, analysis, and communication of real-world evidence by integrating scientific and operational expertise with innovative technology solutions to support global development and commercialization of medical products for life science companies. The company is headquartered in Bethesda, Maryland, with offices located in the United States, Canada, Europe, Latin America, and Japan. For more information about UBC, visit www.unitedbiosource.com<http://unitedbiosourcecorporation.cmail3.com/t/y/l/kktljt/kltlukeh/j>.

 

Corporate Brochure<http://unitedbiosourcecorporation.cmail3.com/t/y/l/kktljt/kltlukeh/t>

Other UBC Presentations<http://unitedbiosourcecorporation.cmail3.com/t/y/l/kktljt/kltlukeh/i>

Visit our website for more information: unitedbiosource.com <http://unitedbiosourcecorporation.cmail3.com/t/y/l/kktljt/kltlukeh/d> or email info@unitedbiosource.com

Posted: September 2009

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