FDAnews Announces — False Claims Act Liability for Regulatory Noncompliance: An Update for Drug and Device Manufacturers Webinar, Oct. 19, 2016

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How can violations of FDA requirements for promotion and marketing, adverse event reporting or cGMPs trigger the False Claims Act (FCA)? Join Anna Laakmann, Counsel, Greenberg Traurig, on Oct. 19 for the False Claims Act Liability for Noncompliance webinar when she’ll explain how regulatory noncompliance can form the basis of an FCA enforcement action by the government.

False Claims Act Liability for Regulatory Noncompliance:
An Update for Drug and Device Manufacturers
**An FDAnews Webinar**
Oct. 19, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://info.fdanews.com/false-claims-act-liability-for-regulatory-noncompliance-pr    

How can violations of FDA requirements for promotion and marketing, adverse event reporting or cGMPs trigger the False Claims Act (FCA)?

Drug and device manufacturers need to know because an interim final rule from the Department of Justice virtually doubles penalties for FCA violations.

Join Anna Laakmann — Counsel, Greenberg Traurig — on Oct. 19 when she’ll explain how regulatory noncompliance can form the basis of an FCA enforcement action by the government. She’ll highlight areas of regulatory risk and discuss key developments about the implied certification theory of FCA liability.

After attending this 90-minute webinar attendees will know:

  •     Common scenarios in which regulatory violations can give rise to FCA liability
  •     How to avoid FCA claims based on promotion and marketing
  •     The consequences of failing to report adverse events
  •     The impact of recent FCA cases and its effect
  •     Implications of the U.S. Supreme Court’s recent decision in Universal Health Services v. Escobar

Register today and remain in compliance with the interim final rule of the FCA.

Meet the Presenter:
Anna B. Laakmann, of Counsel at Greenberg Traurig, focuses her practice on litigation and regulatory matters for pharmaceutical, medical device, and life sciences companies. Before joining the firm, Anna was an associate professor at Lewis & Clark Law School, where she taught medical technology law, bioethics and public health law, intellectual property survey, patent law and policy and property. Anna has written and spoken extensively on the impact of civil litigation and government regulation on scientific research and the practice of medicine.

Who Will Benefit:

  •     Compliance Professionals
  •     Quality Professionals
  •     Sales & Marketing Teams
  •     Regulatory Affairs
  •     Contractors/Subcontractors
  •     Auditors
  •     Consultants/service providers
  •     Executive management
  •     General/corporate counsel
  •     Investigators
  •     Managers
  •     Manufacturing directors and supervisors
  •     Personnel new to the industry
  •     Pharmaceutical and cGMP auditors
  •     Regulatory/legislative affairs professionals
  •     Risk management specialists
  •     Strategic planning and business development staff

Webinar Details:
False Claims Act Liability for Regulatory Noncompliance:
An Update for Drug and Device Manufacturers
Oct. 19, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://info.fdanews.com/false-claims-act-liability-for-regulatory-noncompliance-pr    

Tuition:
$287 per site

Easy Ways to Register:
Online: http://info.fdanews.com/false-claims-act-liability-for-regulatory-noncompliance-pr            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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