A required course in the Certificate Program in Clinical Trials: Medical Device and Drug Development, and an elective course in Medical Product Development.
Course closed to new registrations:
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Gain an understanding of the accepted good principles and practices applicable to the development and implementation of drugs and medical devices in a research environment. Enhance your knowledge of topics including: definition of GCPs; the affect of GCPs on the conduct of a clinical trial; applicable regulations from ICH, HHS, FDA, and the state; obligations of investigators, sponsors, monitors, SMOs, CROs, and IRBs in a research engagement; and compliance and accountability during a clinical trial. Learn about the basic elements of the clinical data management process.
Prerequisite: BIOSCI X450, Fundamentals of Clinical Trials, or equivalent experience. Provider approved by the California Board of Registered Nursing, Provider Number 00093, for 30 contact hours.
Robin McIntosh, MBA has 25 years of experience managing the execution and implementation of complex drug development programs within the pharmaceutical, medical device, and biotech industries. Ms. McIntosh is currently Senior Director, Clinical Development, leading the clinical trials with Recros Medica, a start-up company manufacturing aesthetic medical devices. Ms. McIntosh consulted with Caladrius Biosciences, working on autologous cell based therapies for cardiovascular and Type 1 Diabetes trials. As Director of Global Development Operations with Allergan, Inc., Ms. McIntosh was responsible for creating strategy and risk management for delivering fast-paced cosmetic and medical dermatology clinical research studies, leading to the approval of novel drugs and indications. Ms. McIntosh started her career working at Chiron Vision Corporation (a former subsidiary of Chiron Corporation) managing studies ophthalmic refractive surgery. Ms. McIntosh has experience in the development and execution of Phase 1 through 4 development programs in the following therapeutic areas: Aesthetic and Medical Dermatology, Cardiology, Endocrinology, Neurology, Ophthalmology, Acute and Chronic Pain, and Urology. Ms. McIntosh holds a Bachelor of Science degree in Biology from Washington and Lee University, and a Master degree in Business Administration (MBA) from Pepperdine University Graziadio School of Business and Management.
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||04/05/2021||Monday||---||---||Online (Access Begins)||---
|END||06/13/2021||Sunday||---||---||Online (Access Ends)||---