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
Two pre-conference workshops will be held on July 16, 2013. The first, entitled "Industry Roundtable: Addressing the Day to Day Legal, Regulatory, and Business Challenges of Generic Manufacturers," will be offered from 10:00 am to 12:00 pm. The second, entitled "Business Development Master Class: In-House Counsel Perspectives on Selecting and Evaluating Outside Counsel," will be offered from 2:00 pm to 4:00 pm.
The agenda for the Legal and Regulatory Summit on Generic Drugs
can be found here,
and additional information about the post-conference workshops can be found
here. A complete brochure for this conference,
including an agenda, detailed descriptions of conference sessions, list of
speakers, and registration form can be obtained here.
The registration fee for the conference is $2,295 (conference alone), $2,695 (conference and one workshop), or $2,895 (conference and both workshops). Those registering by June 26, 2013 will receive a $200 discount. Those interested in registering for the conference can do so here, by e-mailing [email protected], by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
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