Orange Book Blog

ACI will be holding its first "Legal and Regulatory Summit on Generic Drugs" in New York City on July 17-18.  The conference co-chairs are Shashank Upadhye, formerly of Apotex, and Kurt Karst of FDA Law Blog.

Here's the agenda:

• 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

In addition, ACI is offering two pre-conference workshops: "Industry Roundtable: Addressing the Day to Day Legal, Regulatory, and Business Challenges of Generic Manufacturers" and "Business Development Master Class: In-House Counsel Perspectives on Selecting and Evaluating Outside Counsel."

Orange Book Blog readers receive $200 off registration fees with discount code OBB 200.  For more information or to register, please visit the conference website.