American Conference Institute (ACI) will be holding its Legal and Regulatory Summit on Generic Drugs on July 17-18, 2013 in New York, NY.  ACI faculty will help attendees:

• Adapt to the implementation and economic impacts of the Generic Drug User Fee Amendments
• Understand the opportunities and challenges presented by the Health Care Reform Law's provisions on generic drug reimbursement
• Prepare for the viability and exposure of product liability claims against generic companies
• Comply with new FDA regulations and comprehend the impact of structural changes at FDA's Office of Generic Drugs
• Devise tactics to overcome REMS roadblocks
• Anticipate the possible repercussions of the U.S. Supreme Court's pending decision on reverse settlement payments in the Watson case
• Understand the partnership decisions that can advance your biosimilars agenda
• Grasp the nuances of breaking developments in Hatch-Waxman litigation that extend beyond IP

In particular, ACI's faculty will offer presentations on the following topics:

• The politics and policy of the generic drug industry: Understanding the role of the 113th Congress in shaping the future of generic pharma
• The game changer: Analyzing the legal and business impact of the generic drug user fee amendments
• Breaking developments in Hatch-Waxman litigation . . . Paragraph IV disputes and beyond
• Examining branded-generic alliances that maximize the potential of biosimilars and minimize investment risks
• Reverse payments update: Key strategies to bring to the settlement table
• The evolution of authorized generics agreements including new controversies under health care reform
• A view from the bench: The judges speak on major developments in case law impacting the pharmaceutical industry
• Developing strategies for bypassing roadblocks to REMS-controlled drugs access
• How generic companies are defending against evolving theories of products liability law following Pliva v. Mensing
• Protecting your company from price erosion through improved pricing reimbursement strategies tailored to the generics industry
• Insights from the office of generic drugs
• Eyes on the 180-day prize: Identifying current and future trends to successfully position your generic pipeline strategy

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