Save-the-Date!
Mark Your Calendars!
Our 8th Annual Generic Drugs Summit will be held September 17-19, 2007 at the Fairmont Washington in DC.
If you would like to become a speaker or suggest topics for the upcoming program, please contact Lesly Atlas at 212-661-3500, ext 3120 or email latlas@iirusa.com.
Take a look below and see what our 2006 program was all about!
7th Annual Generic Drugs Summit
The Strategic Event Helping Generic Companies Get Products to Market Faster
The 7th Annual Generic Drugs Summit is the leading generics event where industry leaders gather to share practical strategies and solutions for our industry's top concerns and obstacles. Leverage your attendance with over 20 thought-provoking sessions and case examples on specific legal and business strategies you can act on immediately.
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Legal and Business Challenges
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Strategies for Filing Successful Paragraph IV Certifications
ANDA applicants engaged in patent litigation take home proven strategies as our legal expert takes you through the nuts and bolts of Paragraph IV certifications, helping you gain market exclusivity – an important financial advantage in a tremendously competitive marketplace.
The Follow-On Biologics Struggle Continues: The 2006 Update
By 2010, biologic medicines that accrue an estimated $11.2bn worth of sales annually are expected to lose patent protection in developed pharmaceutical markets. Our esteemed panel of experts explores The Competitive Landscape of Biogenerics: How are Things Shaping Up? and the economic, scientific, regulatory and legal factors affecting the future of follow-on biologics.
Generic Pharma's Race to Merge and Acquire
Learn how and why generic pharmaceutical companies have adopted M&As a vehicle for growth and understand the potential impact upon the generic pharmaceutical market, as well as critical legal issues that companies looking to merge and acquire should watch out for.
Strategic API Sourcing in Generic Pharmaceuticals
Understand the increasingly vital role the API sourcing function plays in driving the success of today's generic firms with an emphasis on ensuring appropriate preparation of DMF to get your product to market faster.
Understanding How to Submit Quality ANDAs to Reduce Approval Time
Gain a comprehensive overview of the ANDA process including the components of an ANDA, as well as potentially problematic issues sometimes raised by FDA reviewers.
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The Competitive Landscape
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View From Wall Street: Changes, Opportunity and Outlook for the Generics Industry
Assess the 2006 environment as well as the outlook for the remainder of this decade with a comprehensive look at key current trends for the generics industry and new strategies generic drug companies are employing to meet the challenges of the competitive marketplace?
Join the Generic Drugs Summit CEO Roundtable
Margins are under pressure from increased competition, cutthroat pricing, growth of brand-name companies' generic subsidiaries and M&A consolidation. How is all of this going to affect the generics industry in the long term and is there light at the end of the tunnel?
Challenges and Opportunities in India
Gain a comprehensive understanding of the advantages India offers as a country for the growth of the Generics business and how the competition is emerging and where it is headed. Is your company prepared?
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Brand-Generic Settlements
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Federal Trade Commission Actions Involving Generic Drugs
The FTC has recently observed that there is an increasing trend toward brand-generic settlements. Hear directly from the FTC on developments in these settlement cases and what it means for the industry at large.
Are Drug Pacts Delaying Generics from Market Entry?
Are these market divisions illegal under antitrust laws, or efficient arrangements that will lead to lower prices for consumers? Our expert panel explores the practical, financial, legal and financial impact of this increasing industry trend.
Trends and Tactics in Litigating and Settling ANDA Proceedings
Understand when it makes sense to settle ANDA cases and what can be done in light of antitrust and other regulatory concerns
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KEYNOTE and FEATURED SPEAKERS
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The Honorable
Henry A. Waxman
U.S. CONGRESS
CALIFORNIA DISTRICT 30
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William Haddad
Chairman &
Chief Executive Officer
BIOGENERICS
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Markus Meier
Asst. Director
Healthcare Division
FTC
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Jean Hoffman
President
Q STREET
ADVISORS & PUTNEY
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Kurt Orlofski
Chief Executive
Officer
PLIVA
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Richard Silver
Senior Vice President
Specialty Pharma Research
LEHMAN BROTHERS
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Sandy Eisen
Chief Medical Officer
TEVA
EUROPE
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Shashank Upadhye
Vice President
Head of Intellectual Property
SANDOZ US
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Vickie O'Neill,
VP, Research & Technology
UPSHER-SMITH
LABORATORIES
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Group discounts are available. Take this opportunity to send your WHOLE TEAM. For more information on group discounts, please contact Aloycia Bellillie at 212-661-3500, ext 3702 or email her at abellillie@iirusa.com. Note: no two discounts can be combined.
