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The Center for Professional Advancement, 90 Minute Accredited Online Training
August 20, 2009 at 11:00 a.m.–12:30 p.m. (EST)
Who Should Attend
This course is a must for tobacco manufacturers, and suppliers and importers of tobacco products. Individuals from industry and government within the following positions will find the course beneficial:
• Quality Assurance and Control
• Regulatory Affairs Representatives
• Managers
• Sales Personnel
• Manufacturers
• Physicians
• Health Care Providers and Practitioners
• Attorneys and In-House Counsel
• Risk Managers
• Enforcement Personnel
• Federal, State and Local Government
In addition, groups/organizations/individuals who are interested in the impact this new regulation will also benefit. Description
On June 22, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act . This historic legislation, a long time in the “making”, conferred authority to FDA to regulate tobacco products. This law changed the United Stated Federal Food, Drug and Cosmetic Act by permitting FDA regulatory authority to cover tobacco products. This 90-minute accredited training will focus on the legal issues involving tobacco regulation by FDA. The program will examine litigation issues, regulatory matters as well as current topics. The landmark United States Supreme Court decision of Brown & Williamson Tobacco Co. v. FDA that set in motion this legislation will be analyzed. Participants will be given information on how to make their voice heard in how this historic law will unfold.
Module 1:
• Overview of the Family Smoking Prevention and Tobacco
Control Act
• What Led Up to this Historic Legislation
– Federal Efforts to Regulate Tobacco
– Jurisdiction of the United States Federal Food and Drug
Administration to Regulate Tobacco
– “The” Landmark United States Supreme Court Decision:
Brown & Williamson v. FDA
Module 2:
• Key elements of the Family Smoking Prevention and
Tobacco Control Act
• The United States Food and Drug Administration (FDA)
Authority to Regulate Product Promotion-Tobacco
Advertising
• Labeling issues
Module 3:
• How to Make Your Voice Heard
– Submission of Comments
• Special Topics
– Economics
– "Politics"
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 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.
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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