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The Center for Professional Advancement, 90 Minute Accredited Online Training
August 4, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
Who Should Attend
This course is a must for anyone in the medical device regulatory field including personal in the following positions:
• Quality Assurance and Control
• Regulatory Affairs
• Medical Device Representatives and Managers
• Sales Personnel
• Manufacturers
• Physicians
• Pharmacists
• Health Care Providers and Practitioners
• Attorneys
• In House Counsel
• Risk Managers
• Enforcement Personnel
Description
The duty of the health care provider, medical device manufacturer and pharmacist to warn has become more and more important and complicated especially with the United States Supreme Court landmark decision of Riegel v. Medtronic. This 90-minute accredited online program offers the opportunity for participants to learn the latest about legislative initiatives. The Duty to Warn will be analyzed. The course will include a case study demonstrating a lawsuit brought against a medical device manufacturer for the failure to warn.
Module 1:
• What is Preemption?
• How does the Preemption Doctrine apply to Medical
Devices?
Module 2:
• Who has a specific duty to warn – Health care provider or
medical device manufacturer?
• Update on Legislative Initiatives
Module 3:
• What are the ethical considerations involved?
• Case study
Questions 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 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. www.fortipublications.com
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.
Course Materials:
Roseann B. Termini, Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements, FORTI Publications 3rd edition. www.fortipublications.com
Termini, Statutory Supplement Health Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements, FORTI Publications, 3rd edition. www.fortipublications.com
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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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