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Mar 20 2012 -
Mar 21 2012
8:00 AM - 12:15 PM

Doubletree Suites Times Square
, New York, NY
The FDA Boot Camp, hosted by American Conference Institute, is designed to give products or patent litigators, patent prosecutors, industry in-house counsel and life sciences investment and securities experts with a strong working knowledge of core FDA competencies. Over the course of two days, a distinguished faculty of top FDA regulatory experts — including Buchanan Ingersoll & Rooney's Linda Pissott Reig — will share their knowledge and give you critical insights on approval processes for drugs, biologics and devices; clinical trials; classitification and labeling; the role of Hatch-Waxman in patenting; monitoring and signal detection; and recalls, product withdrawals and FDA oversight authority.

Reig will open the second day of the event with a lecture on "Adverse Events Monitoring, Pharmacovigilance and Risk Management," which she will co-present with Mark W. Lynch, former assistant general counsel for Pfizer. Among the topics Reig and Lynch will address are:
  • What is pharmacovigilance?
  • How does pharmacovigilance uses adverse event reports?
    • How do ADE reports come to a company?
      • Solicited direct reports
      • Unsolicited direct reports
      • Indirect reports
    • How do companies investigate, analyze and use ADE reports?
      • Causality assessments
      • Labeling changes
    • What are the requirements for reporting ADEs to regulatory agencies?
      • Premarket stage
      • Post-market stage
    • How do regulatory agencies use ADE reports?
    • What are other tools for pharmacovigilance?
    • What is risk management?
      • The new Risk Evaluation and Minimization Strategies (REMS) law
      • Risk evaluation in the approval process
      • Risk minimization tools
      • REMS assessments
    • How are ADE reporting and REMS requirements enforced?
    • What is the relevance to product liability risks?