ACI "Legal and Regulatory Summit on Generic Drugs," New York City, July 24-25

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.

ACI "Legal and Regulatory Summit on Generic Drugs," New York City, July 24-25