American Conference Institute (ACI) will be holding its inaugural Legal, Regulatory and Compliance Guide to Orphan Drugs and Rare Diseases in Boston at the Hyatt Regency on November 28-29, 2012. This unique program features a distinguished faculty of over two dozen leading legal and regulatory orphan drugs and rare diseases experts – including the former director of FDA’s Office of Orphan Products Development, senior in-house pharmaceutical counsel, leading patient advocates, and preeminent FDA and patent attorneys – who will address the intricacies of the FDA’s orphan drug designation process as well as the challenges affecting orphan drug development and commercialization and overall patent portfolio considerations.
The ACI conference provides a comprehensive forum for the industry to discuss the latest legal and regulatory developments affecting orphan products and therapies for rare diseases and to analyze the strategic considerations in drug development aimed at providing patients facing an unmet medical need with safe and effective life changing therapy. In light of recent cases concerning FDA enforcement of orphan exclusivity, the conference will also feature a spotlight session on “Protecting Orphan Drug Designation and Proactively Guarding Against Potential Liability.”
More information about this event, including a full agenda, faculty list, and brochure can be accessed at www.AmericanConference.com/orphandrug
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