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
How do companies investigate, analyze and use ADE reports?
What are the requirements for reporting ADEs to regulatory agencies?
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
How are ADE reporting and REMS requirements enforced?