ACI Legal and Regulatory Summit on Generic Drugs

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ACI Legal and Regulatory Summit on Generic Drugs


ACI Legal and Regulatory Summit on Generic Drugs

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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