Regulatory Requirements & Strategies for a Successful IND
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Date: October 1, 2008
Time: 8:30 a.m. - 9:30 a.m.
Location: Pharmatek Laboratories, Inc.
Speaker: Patricia D. Williams, Ph.D., COO, Summit Drug Development
Presentation Summary
Dr. Williams will provide an overview of the regulatory process and the strategies that can help to ensure a successful IND submission. At the heart of a successful IND is effective strategic planning that includes communication with FDA and the use of regulatory tools that are appropriate for the product under consideration. Examples of INDs will be presented that will illustrate the diversity of approaches and strategies that can be used to advance new products into clinical testing.
About the Speaker
Patricia Williams, Ph.D., is a pharmaceutical executive with over twenty five years of experience in drug discovery and development in the pharmaceutical, biotechnology and contract service industries. She is currently the Chief Operating Officer of Summit Drug Development Services LLC, a drug development service company located in Rockville, Maryland. Dr. Williams has held various management positions in safety assessment, regulatory affairs and project management at TherImmune Research Corp./Gene Logic Corp., SRA Life Sciences, Inc., BioChem Therapeutic, Inc., Glycomed, Inc./Ligand Pharmaceuticals, Bristol-Myers Company, Eli Lilly & Company and American Cyanamid Company.
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