(WINTER 2010)

An elective course in the Certificate Program in Clinical Trials: Medical Device and Drug Development.
Structuring the knowledge and expertise to conduct a clinical trial is instrumental in establishing your project plan. Learn how to organize your clinical trials project teams, define specific responsibilities for each team member, and create a project plan for either U.S. trails or Global trials. Participants will evaluate clinical and regulatory strategies for U.S. and Global approvals and become familiar with common standards of operation (SOPs) for clinical trials. Also addressed is the financial management of a clinical trial, negotiating contracts, and understanding how to interact with contract research organizations (CRO's). Prerequisite: BIOSCI X450, Fundamentals of Clinical Trials, or equivalent experience. See enrollment confirmation for login information.

Susan Miller, B.S., is an independent consultant in clinical trials and regulatory affairs.She is responsible for the implementation and management for clinical studies for biotechnology, pharmaceutical and medical device industries from inception to completion. Her 20 years experience in the Life Science industry has ranged from product development management to clinical studies to regulatory affairs. Miller serves as liaison with FDA and other regulatory agencies, along with technical document preparation and submission, and GCP auditing.