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See more Regulatory Affairs Expert WitnessesThis expert is the president of a healthcare government relations and regulatory policy consultancy firm that she founded after an extensive career in healthcare and government. She was the Vice President for Government Relations and Public Policy at Celgene and was the Vice President for Regulatory Policy at GE Healthcare. She served in the administration of President George H.W. Bush as Special Assistant for Legislative and Public Affairs in the Office of the Commissioner, US Food and Drug Administration. She is a certified Regulatory Affairs specialist and is the author of numerous reports and is currently on the Board of Directors of the FDA Alumni Association. Her formal education includes a BA in Government from Georgetown University and an MS in Science and Technology Commercialization from The University of Texas at Austin.
President, A Biotech Consultancy
Master of Science (MS), University of Texas at Austin
Milwaukee,
Wisconsin
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FAQs for Regulatory Affairs Expert Witnesses
What is the role of a Regulatory Affairs expert witness?
A Regulatory Affairs expert witness provides insight and testimony on matters related to regulatory compliance, product approval processes, and industry standards in various sectors.
In what types of cases can a Regulatory Affairs expert witness be beneficial?
These experts are crucial in cases involving pharmaceuticals, medical devices, food safety, environmental regulations, and any sector where regulatory compliance is key.
How can a Regulatory Affairs expert witness assist in a pharmaceutical case?
They can provide insights into FDA approval processes, drug safety regulations, labeling requirements, and other aspects of pharmaceutical regulatory affairs.
Are there subspecialties within the field of Regulatory Affairs that an expert witness might focus on?
Yes, some experts may specialize in specific areas like pharmaceuticals, medical devices, biotechnology, or environmental regulations depending on their experience.
Why is it important to have a Regulatory Affairs expert witness with industry-specific knowledge?
Industry-specific knowledge ensures the expert is familiar with the unique regulatory landscape of that sector, providing accurate and relevant testimony.
How does Expert Institute select its Regulatory Affairs expert witnesses?
Expert Institute offers a personalized approach to help you find the highest quality experts. We source actively-practicing professionals who match all your requirements for specialty areas, work experience, litigation history, fee range, certifications, location, and more.