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CfPA, 90 Minute Accredited Online Training
May 19, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
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
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Roseann B. Termini, B.S., Ed.M., J.D.
Ms. Termini’s past expertise entails an appellate law clerkship and the sole corporate counsel for a pharmaceutical company and a regulatory affairs attorney. As senior deputy attorney general, Office of Attorney General, she successfully litigated and prosecuted numerous cases at the trial and appellate levels including a landmark decision. Her special appointment involved the Plain Language Consumer Contract Act implementation and she was first recipient of the Statewide PA Bar Association Plain English Clarity Award.
Ms. Termini presents specialized programs in food and drug law. She has authored numerous articles in scholarly publications primarily focusing on specialized issues involving food safety, dietary supplements and pharmaceutical law. In addition, her comprehensive books Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements 3rd ed. and CD 3rd ed. and Training Manual serve as valuable resources for both regulators and the regulated community.
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Deadline for Abstracts:
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N/A
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Registration:
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Please click here for registration information.
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E-mail:
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salbers@cfpa.com
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