This three-day educational program immerses attendees in the statutes, regulations, and other guidance that comprise the body of law known as "fraud and abuse law," as well as other healthcare-related laws and regulations, to help the audience understand the legal underpinnings of the life sciences compliance education programs they develop and enforce.
Who Should Attend
Professionals working for smaller pharmaceutical, biotech, medical device and diagnostics companies – particularly those working in a compliance, legal, regulatory or, medical affairs role. This program is also valuable for sales, marketing, grants and related areas, as well as outside counsel who represent life sciences companies and private equity and venture capital firms that fund these companies.
Program faculty includes law professors, in-house compliance officers, high-level government, and private lawyers who are experts in pharmaceutical and medical device fraud and abuse issues.
Session topics include Federal and State False Claims Acts, Federal Anti-Kickback Statute, the Food, Drug & Cosmetic Act (FDCA), Data Privacy (HIPAA, HITECH, and others), Food & Drug Administration Amendment Act of 2007 (FDAAA), International Anti-Corruption Laws, Prescription Drug Marketing Act of 1987 (PDMA), PhRMA Code and AdvaMed Code, the federal Sunshine Law, federal and state marketing and disclosure laws, OIG compliance guidance, and much more.
Attendees receive extensive resource materials that will aid them in their ongoing compliance efforts.
Attendees will receive a certificate issued by Seton Hall Law School upon completion of the Program, and may apply for NY and NJ CLE credit.
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