Dr. Albert Rego, Ph.D., M.B.A., is a scientific consultant to the regulated industries, with over thirty years of experience in the pharmaceutical and medical device industries. Areas of specialization are in the national and international regulatory aspects of the scientific testing requirements for chemical, biological, and sterilization technologies. He has experience in performing, directing, designing, and evaluating clinical and non-clinical studies for pharmaceuticals and medical devices. Selective expertise includes chemical stability testing, medical device evaluations, statistical design and interpretation, regulatory submissions, chemical hygiene plans, analytical chemistry methodologies, and sterilization validation.
Catherine A. Kusnick, MD is a UCI medical school graduate and Principal, Headlands Consulting. She has headed clinical departments at medical device start-ups for 8 years after 2 years in pharma. She currently consults with device start-up companies. Her strategic and tactical experience includes study conduct, project management, data analysis, Medical Affairs, writing Regulatory submissions. While practicing medicine, she taught at two medical schools, served as a Study Investigator and published/lectured extensively.
Textbooks for your course may be purchased from any vendor or bookseller of your choice.
No textbooks are required for this course.
|Event||Date||Day||Start Time||End Time||Location||Room
|START||03/29/2021||Monday||---||---||Online (Access Begins)||---
|END||06/06/2021||Sunday||---||---||Online (Access Ends)||---