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PTEK U Seminar Series

Regulatory Intelligence: What is it and how can it accelerate your company's drug development?
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Date: April 15, 2010
Time: 8:30 a.m. - 9:30 a.m.
Location: Pharmatek Laboratories, Inc.
Speaker: Sybille L. Sauter, Senior Regulatory Scientist, Ph.D., R.A.C. (US & EU), Cato Research Ltd.

Presentation Summary

Understanding regulatory intelligence and why it should be an essential part of the overall drug development strategy is essential. Regulatory intelligence represents a snapshot of the legislation and guidance documents, the regulatory environment, and competitive intelligence collected at the time a product is under evaluation. This information is publicly available. During this discussion, we will review the various tools that can be used to gather relevant documents and to navigate the regulatory landscape. In addition, we will briefly touch on commercial electronic regulatory databases established by several companies. Finally, examples will be presented how regulatory intelligence can be used to answer key questions pertaining to regulatory and overall product development strategies and help shorten the timeline to get a product to market.

About the Speaker

Dr. Sauter is a Regulatory Affairs Scientist and Project Manager at Cato Research where she is responsible for preparing, reviewing, and managing regulatory, clinical, and scientific documents such as clinical study reports, FDA meeting packages, requests for orphan drug and fast track designations, and regulatory intelligence reports. Dr. Sauter contributed to successful submissions to regulatory authorities encompassing various products, indications, and development stages. She serves as a regulatory affairs scientist as well as an analyst with Cato BioVentures utilizing her skills in regulatory strategy and operations. Dr. Sauter earned her Ph.D. in molecular biology at the University of Tuebingen, Germany. Before joining Cato Research, she held positions in R&D as a scientific program leader developing human therapeutics at various biotechnology companies in California (e.g., Viagene, Chiron, GenStar). Dr. Sauterís therapeutic areas of expertise include genetic disorders, vaccines, and infectious diseases such as HIV/AIDS using viral vector-based technologies. Dr. Sauter has earned Regulatory Affairs Certification for the US and the European Union.