The Food And Drug Amendments Act of 2007-Does IT Affect You?

"The FDAAA of 2007 imposed several new regulations on clinical trial registration and disclosure. Non-compliance can result in severe penalties. Do you know how these apply to you?"

The Food and Drug Administration Amendments Act (FDAAA) of 2007 imposed several new strict regulations on clinical trials. Under this act, the majority of clinical trials must now be registered, and must disclose their results publicly and in a timely manner. Moreover, non compliance with these regulations can result in severe penalties, since their purpose is to ensure that public health is kept a priority. It is therefore vital to understand these new amendments well and comply with them properly.

This FDAAA (The Food and Drug Administration Amendments Act) training will show you how to do this. It will also guide you through an overview of the FDAA, summarizing the new provisions regarding specialized pediatric medical device development, food safety, advisory committee provisions, clinical trial registries and drug safety enhancement provisions.

Areas Covered in the seminar:

• How to reauthorize existing laws.
• The Reagan-Udall Foundation.
• Improved Clinical Trial Databases and their Requirements.
• The requirements of clinical trial registry.
• FDA’s new authority to address post market and surveillance issues concerning medical products.
• New provisions regarding food safety.
• Advisory Committee provisions.
• The new user fee program that supports the FDA’s review of direct-to-consumer advertising.

Who will benefit:

This webinar will provide valuable information to those who develop and market Medical Devices, Pharmaceuticals for both adults and children, Biologics and those engaged in the manufacture and distribution of food.

• Regulatory Affairs officials in the FDA regulated industries
• Those personnel engaed in Clinical trials and the sponsors of clinical trials
• Medical Researchers

Instructor Profile:

Sandra N. Whetstone, is a former (retired) US Food and Drug Administration (FDA) executive. She has more than 35 years of experience as a US Food and Drug official and is a recognized expert in US Food and Drug Law, the Public Health Service Act and related statues. Mrs. Whetstone is a co-founder and Managing Director of Comprehensive Compliance Solutions, LLC, a consulting company specializing in all aspects of FDA regulatory compliance matters relative to human and veterinary drugs, biologics, medical devices and foods. She has developed and presented cGMP training courses for various segments of the pharmaceutical industry.

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