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Informationen zum Autor Michael J. Roy, Ph.D., RAC, is an adjunct professor in the Master of Science Biotechnology Program in the School of Medicine and Public Health at the University of Wisconsin-Madison. He teaches Biotechnology Operations and Project Management and Leadership. He has successfully developed biopharmaceutical and medical device products for more than 22 years, serving as a consultant in biotechnology since 2001. Much of his work has focused on early development of novel biotechnology products and medical devices with emphasis on product development planning, regulatory affairs, quality systems, and project management. He received a Ph.D. in Pathology from University of Wisconsin-Madison, an MS in Tropical Medicine and Medical Parasitology from Louisiana State University Medical Center, and a BS in Biology from the University of Wisconsin-Platteville. In addition, he holds Regulatory Affairs Certification (RAC). Mr. Roy is a retired colonel in the U.S Army. While serving, he was involved in the development of in vitro diagnostics and vaccines and in establishing ISO (International Organization of Standards) quality systems at the U.S. Army Medical Research Institute of Infectious Diseases, Ft. Detrick. Klappentext Based on the author's five years of teaching! this book introduces key biotechnology developments and covers critical elements such as project management! regulatory affairs! quality assurance! biomanufacturing! quality control! nonclinical safety testing! and clinical evaluation. The author discusses these subjects in relation to development planning! process and pathways! management of integrated projects and the business and economic aspects of development. Using simple language and explanatory figures! it describes the functional areas that must be successfully integrated to bring a biotechnology product to market. Inhaltsverzeichnis Introduction to Biotechnology Operations: Planning for Success. Project Management. Regulatory Affairs. Regulatory Compliance. Quality Systems. Biomanufacture. Quality Control. Nonclinical Studies. Clinical Trials. Glossary. Additional Reading. Practical Problems and Questions. ...
