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Generic Drugs Summit Generic Drugs Summit

June 18 - 20, 2008 | Ritz Carlton, Washington, DC

Event Overview

Event Overview

Dear Colleague,

In 2008 more than 10 top-selling drugs will lose patent protection.

With billions of dollars in patent expirations looming for Big Pharma over the next couple of years, the industry as a whole is at an inflection point. With Big Pharma’s scarcity of innovative products on the horizon, what impact will this have on the future of generic drugs firms’ bottom line? Does your company have strategies for growth in place? How do the latest outcomes in patent settlements between innovators and generic firms affect your business? What does Wall Street have to say about the current and future outlook on the generic drugs industry?

It’s uncertain times for the Generic Drugs industry….

What changes lie ahead for the generic industry in light of this Presidential election year? The Democratic candidates have been vocal advocates for the removal of barriers blocking generic drugs and of creating a pathway toward FDA approvals for biogenerics. However, many feel generic biopharmaceuticals are a distant threat to the U.S. biotech firms due to questions about manufacturing, FDA resources and politics. How and when will FDA address the core fundamental issues that are blocking timely consumer access to affordable generics? Will Congress move on follow-on biologics in the foreseeable future, and is your company prepared for the marketplace?

That’s why strategic planning for growth is imperative in today’s competitive marketplace

Your best opportunity to gather information and advice on policy, business and legal issues such as these impacting the generics marketplace - and your bottom line - is NOW. Register today for the leading independent forum addressing business and legal concerns impacting the generics marketplace and your company’s bottom line. This event attracts 200+ senior-level professionals representing government, regulatory and legal affairs as well as marketing, sales and business development.

2008 Pre-Conference workshops:

Strategies for Filing Successful Paragraph IV Certifications

This workshop explores the strategies ANDA applicants engaged in patent litigation can implement as our legal expert takes you through the nuts and bolts of Paragraph IV certifications in an interactive workshop format.

Understanding How to Submit Quality ANDAs Based on QbR to Reduce Approval Time

This workshop provides an overview of the ANDA process including the components of an ANDA with an update on what you need to know about the Quality-based Review approach which the FDA’s Office of Generic Drugs has fully implemented.

Reserve your seat at this conference today. Take advantage of our group discounts to send your entire team. To register, please use the form on the back of this brochure, call us at (888)670-8200 or (941)951-7885, or fax us at (941)365-2507. We look forward to greeting you on June 18-20 in Washington, DC.

Sincerely,

Lesly Atlas, Event Director
9th Annual Generic Drugs Summit

Sponsors

  • Locke Lord Bissell & Liddell LLP

  • Brinks Hofer Gilson & Lione

  • Wolf Block

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