Orange Book Blog

American Conference Institute will be holding its 2nd annual "Legal and Regulatory Summit on Generic Drugs" in New York on July 24-25.  The conference promises to present "comprehensive strategies for the generic pharmaceutical industry's present and future challenges."

Here is the complete agenda:

• Unearthing Changes at the Office of Generic Drugs and Understanding Their Impact on the Future Growth and Evolution of the Generic Drug Industry
• Deciphering GDUFA and Its Impact on ANDA Approvals, Profit Margins, and Performance Metrics
• Demystifying the FDA's Rulemaking Authority: Exploring How FDA's Proposed Labeling Rule and Other Proposed Rules and Guidances Will Affect the Dynamics of the Generic Pharmaceutical Industry
• The Changing Paradigm of the Generic Drug Market Entry: Assessing Brand Name Drug Vulnerabilities and New Targets for Generic Drug Manufacturers
• Operating in the Post-Bartlett Landscape in Light of New Decisions and FDA Rulemaking
• The Case for Generic Drug Quality: Understanding How Quality Initiatives in Congress and FDA, and DOJ Enforcement Activity Have Impacted the Generic Drug Industry
• Mitigating the Effects of New Stability Data Requirements to Ensure the Integrity of Generic Drugs
• Exploring Strategies for Biosimilar Development in the United States: Regulatory, IP & Commercial Considerations Gleaned from the Global Framework
• Exploring New Developments and Related Tactics in Hatch-Waxman Litigation That Are Impacting the Strategies of Generic Drug Manufacturers
• Developing Settlement and Negotiation Methods Post-Actavis to Minimize Chances of Costly Government Enforcement Actions
• View from the Bench: The Judges Speak on Major Developments Affecting the Generic Drug Industry
• Comprehending How Mergers and Acquisition Activity and Collaborative Partnerships Are Impacting and Changing the Dynamics of the Generic Pharmaceutical Industry
• Examining Provisions of the Affordable Care Act Impacting Generic Drug Pricing and Reimbursement

ACI is also offering two pre-conference workshops on July 23: "Understanding and Working with the FDA's Office of Generic Drugs: Jurisdiction, Organization, and Operations" and "OGD Roundtable: Gaining Priceless Insights on the Inner Workings of the FDA's OGD from Former OGD Officials."

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