Failure to Warn and Preemption
Wyeth v. Levine Supreme Court Milestone Decision’s Impact on the US Pharmaceutical Professional
This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.
This course is available as a client site course. Please click here for more information.
Who Should Attend
This online training is a must for anyone in the Pharmaceutical Industry with job functions in the regulatory field, quality assurance and control and regulatory affairs. The course material will be extremely valuable to:
• Drug Representatives
• Managers
• Sales Personnel
• Manufactures
• Physicians and Pharmacists
• Health Care Providers and Practitioners
• Attorneys and In House Counsel
• Risk Managers
• Enforcement Personnel
Description
The duty of the health care provider, drug manufacturer and pharmacist to warn has become more and more important especially with the United States Supreme Court landmark decision of Wyeth v. Levine. This 90-minute, accredited online training program offers the opportunity for participants to find out the latest about drug warnings.
The failure to warn will be analyzed; a specific case study will be used addressing a lawsuit brought against a drug manufacturer for the failure to warn. Another case review will analyze the interplay of the learned intermediary and the duty of a drug manufacturer to warn. This is your opportunity to become a judge by taking part in lively interactive discussion!
Module 1:
• Impact of the failure to warn
• Who has a specific duty to warn?
-Health care provider
-Pharmaceutical manufacturers
-Pharmacist
Module 2:
• Does direct-to-consumer advertising
impact on the duty to warn?
• Preemption- What it and how does it apply to the
duty to warn and the failure to warn?
Module 3:
• What are the ethical considerations involved?
• Check points during drug GMP system-based audits
• What is and how does the learned intermediary
doctrine come into play?
• Case Study
Question and Answer Session