Regulatory Affairs Expert Witnesses in Illinois
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Regulatory Affairs Experts in Illinois
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FDA Medical Device Regulatory Requirements Expert Witness
This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Currently, he is an Industry Consultant with a leading FDA consulting corporation.
Industry Consultant, An FDA consulting corporation
Bachelor of Arts (BA), California State University
East Alton,
Illinois
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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.