The Center for Business Intelligence (CBI) will be
holding its Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle
Strategies on January 20-21, 2009 in Baltimore, MD. The conference will address the current challenges,
policies, and practical strategies from both legal and regulatory perspectives
to help companies implement a more effective and modern approach to lifecycle
management (LCM).
Topics to be discussed at the conference include:
• The implications of the European Commission (EC)
investigations on the pharmaceutical industry;
• Increase return on investment (ROI) through the
integration of lifecycle management with portfolio management;
• The interplay between patent law and regulatory law to
maximize product lifecycle;
• Assess the impact of carve-outs and citizen petitions
on LCM strategies; and
• Managing in-licensing and the collaboration continuum.
In particular, CBI's faculty will offer presentations on the following topics:
• Antitrust law and LCM -- The FTC's view on risks and
regulations;
• The expected implications of the EC pharma inquiry on
industry;
• Assess your patent portfolio to assign value and
identify risks and opportunities;
• The interplay between patent law and regulatory law to
maximize product lifecycle;
• Lifecycle management in emerging economies;
• Understand labeling carve-outs and their impact on
generic approvals;
• Trademarks -- Overcome the regulatory challenges to
effectively utilize trademarks in your LCM strategies;
• Evaluate the potential for alternate drug exclusivity
pathways;
• Integrating lifecycle management with portfolio
management to maximize asset value; and
• Drug repurposing -- Call to service for old drugs; when
being opportunistic is the strategy.
An additional in-conference workshop entitled: "Lifecycle Boot Camp -- The Core Laws and Regulations Affecting Your Strategies" will be offered on January 20, 2009. The in-conference workshop will review Hatch-Waxman and MMA legislation, and USPTO proposals -- with a special focus on patent term extensions, Orange Book practices, ANDA litigation, and other laws and regulations that apply to LCM. The workshop will also provide practical strategies for successfully working within these regulations and the common pitfalls to avoid.
The agenda for the Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies can be found here. A brochure for this conference can be requested here.
The registration fee for the conference is $1,995. Attendees registering on or before
November 21, 2008 will receive a $300 discount off the registration fee, and
attendees registering a group of three individuals will receive a fourth
registration for free. Those
interested in registering for the conference can do so here, by calling 1-800-817-8601,
or by e-mail at [email protected].
Patent Docs is a media sponsor of CBI's Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies .
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