Integrated Safety and Risk Assessment for Medical Devices and Combination Products (Hardcover) (ISBN-13: 9783030352400)

Dr. Shayne Gad has over 43 years experience as a toxicologist, statistical consultant, manager and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is experienced in occupational and industrial toxicology, development programs (both preclinical and clinical) and study design, conduct and reporting, in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies, commercial concerns, and contract research organizations; in labeling and other FDA compliance issues for drugs, devices and dietary supplements; identifying, developing and putting into everyday use new technology; in writing reports, position papers, Material Safety Data Sheets, MAA/PLA/IND/NDA/PNA toxicology and pharmacokinetic summaries and package inserts; in preparing and maintaining INDs, MMFs, NADAs, DMFs, IDEs and 510(k)s; in preparing labels and package inserts for drugs, devices, combination products and consumer products; in presentations to FDA and in designing experiments, designing and executing surveys; in the pharmacokinetic and statistical analysis of both experimental and clinical data; in risk assessment; in Proposition 65 assessments and labeling; in the registration of OTC, dietary supplement, nutraceutical, and sterilant products with FDA; and in the development and production of biologic products. Author/editor of 50 books, 67 independent chapters and more than 350 peer reviewed papers and abstracts.