Overview
Build your expertise by refreshing your understanding of the statistics that underpin clinical trials, consistent-with-labeling decisions, consumer use data, and more. Speakers will go over key concepts such as statistical significance, p values, confidence intervals, sample size determination, post hoc subgroup analysis, meta analysis, and noninferiority and superiority trials. This session will run through typical questions and misperceptions about statistics to strengthen your data-driven communications in the FDA-regulated world.
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Speakers
Mark Levenson, Director, Division of Biometrics VII, Office of Biostatistics, CDER, FDA
Lance L. Shea, Partner, BakerHostetler
Moderated by William Garvin, Shareholder, Buchanan Ingersoll & Rooney PC
LANCE SHEA is a partner at BakerHostetler LLP with focus on legal science advocacy, Mr. Shea represents clients in medical products industries such as drugs, medical devices and biotechnology products. Matters span regulatory (e.g., FDA and EPA) and litigation forums (e.g., federal and state courts) and often involve complex scientific evidence and cutting-edge arguments based on interpretation of scientific studies. In recent regulatory matters, Lance advised clients on assessment of safety signals for prescription drug products, drug postmarketing studies required under Risk Evaluation and Mitigation Strategy (REMS), preparation for cGMP food inspection and efficacy, and safety positions based on epidemiology studies of competing medical device products. In litigation matters, he recently represented drug companies in nationwide dockets of products liability cases and a drug/device company on breach of contract litigation.Summer Learning Series
The Summer Learning Series brings the top thinkers and leaders of our industry to speak on a broad array of topics essential to the food and drug law professional, covering matters that perhaps we all wish we knew a bit more about as we work and converse with clients, colleagues, and the FDA. Join us this June through July and build foundation in the following subjects:
- The Essentials of Clinical Trial Science – Wednesday, June 16
- The Essentials of Statistics for Medical Products Lawyers – Wednesday, June 30
- The Essentials of Tobacco and Nicotine Product Research – Wednesday, July 14
- The Essentials of Machine Learning for Regulatory Attorneys and English Majors – Thursday, July 15
- The Essentials of Food Science – Wednesday, July 21
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