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Today is Sep 5, 2010
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There is more to regulatory intelligence than regulations and guidelines. Regulatory precedence, industry practices, regulatory agency opinions, etc., are valuable sources of information that may help to develop successful regulatory strategies. This presentation examines the scope of regulatory intelligence: information database versus analysis and periodic versus ongoing. Implementation choices-in-house, consultants, information services, or a mixture-and the advantages/disadvantages of each choice will be discussed.
Meredith Brown-Tuttle, RAC is Manager, Regulatory Affairs for PDL Pharma, Inc. She is responsible for all of the aspects of worldwide regulatory affairs research and submissions. Ms. Brown-Tuttle has worked in the industry for over 11 years and her background incorporates all aspects of drug, device and biologics development including, clinical research, data management, medical writing, and regulatory affairs. She is on the Board of Editors for the Regulatory Affairs Professional Society's journal, "Focus" and has published articles, book chapters and presented at professional meetings on a variety of clinical research and regulatory topics. Ms. Brown-Tuttle also teaches about regulatory submissions for the Regulatory Affairs Certificate at UC Santa Cruz. Ms. Brown-Tuttle graduated with a bachelors degree in biological psychology from San Jose State University. |