American Conference Institute's very popular "FDA Boot Camp" returns to San Francisco later this month, May 29-30.
The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory competencies. The conference features FDA regulatory and patent law experts from pharmaceutical companies and outside law firms.
Presentations on the agenda include:
- The Basics: Understanding and Working with the FDA -- Jurisdiction, Functions, Organization, and Operations
- The Nature of the Approval Process
- Patent and IP Overview: Hatch-Waxman, Trademark Protection, and More
- From Theory to Practice: FDAAA, Future FDA and Legislative Priorities, Other Enforcement Initiatives, and Beyond
- Non-Patent Exclusivity
- Bioequivalence: What Lawyers Need to Know
- Follow-On (Comparable or Biosimilar) Biologics
For more information or to register, please visit the conference website.
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