Marcus evans will
be holding its 3rd Annual Product and Pipeline Enhancement for Generics
conference on "Navigating Regulatory Pathways and Patent Strategies to
Ensure Market Sustainability" on June 28-30, 2010 in Washington, DC.  The conference will enable attendees
to:

• Achieve effective
patent strategies and gain knowledge on the most recent cases regarding
Hatch-Waxman litigation;
• Hear the latest
regulations from the U.S. regarding product quality for imported materials;
• Obtain a better
understanding on the evolving niche opportunities within the generic
pharmaceutical market; and
• Implement a
global market plan to remain competitive.

In particular, the
conference will offer presentations on the following topics:

• Modeling a
settlement of a Hatch-Waxman litigation taking into account any new provisions
due to the health care effort (conference workshop);
• Assessing the
changes within the industry to gauge the new direction of generic
pharmaceuticals;
• Highlights of
recent developments in patent law and generic exclusivity;
• The MMA "NCE
minus 1" Hatch-Waxman litigation;
• Reviewing the
most recent advancements in patent litigation and determining the impact on the
generics industry;
• Use of pharma's
almanac for opinions to support Paragraph IV certification;
• Effective
strategic planning when writing your ANDA to assure approval;
• Examining the law
impacting hatch-Waxman litigation: Including significant Federal Circuit
decisions;
• Challenges due to
globalization in the pharmaceutical industry;
• Employing strong
market forecasting skills to develop a specialty product portfolio;
• Role of R&D
in the evolving generic business scenario;
• Hosting an FDA
audit of finished dose manufacturing in China;
• OK, you have an
opinion, now how do you evaluate the risk?
• Delving into
recent issues with APIs and understanding the instrumental perspective;
• Recent
developments in generic first-to-file exclusivity forfeiture decisions;
• Examining the
global marketplace for biosimilars to determine viability;
• Prioritizing
opportunities and challenges for biosimilars to assess the potential market;
• Established
products overview through innovator perspective

A brochure for this
conference can be requested here.  The registration fee for the conference
is $2,500.  Those interested in
registering for the conference can do so here.

Patent Docs is a blogging partner of marcus evans' 3rd Annual Product and
Pipeline Enhancement for Generics conference.