The webcast will describe the process of designing clinical studies, covering initial questions that can guide development of a study framework and transitioning into discussion of a multitude of factors that must be evaluated in the design process (e.g., purpose, regulatory pathways, patient population, endpoints, and hypotheses.) You will also hear about additional considerations that can be cost drivers (e.g., monitoring, various oversight committees, etc.)
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Upon the webcast's conclusion, you will be able to:
Who Should Attend
William D. Voorhees III, vice president/chief science officer, MED Institute
William D. Voorhees, PhD, is the vice president & chief science officer at MED Institute. He joined the Clinical Trials/New Product Approvals Group at MED Institute in 1990. Voorhees’ commitment to patients is to ensure the quality and integrity of MED Institute’s research, as well as of submissions to regulatory authorities and manuscripts to disseminate information about this research. He earned his PhD in Veterinary Physiology & Pharmacology from Purdue University and has authored over 70 referenced articles.
Theodore Heise, vice president, regulatory and clinical services, MED Institute
Theodore Heise, PhD, has 25 years of experience in regulatory affairs and currently serves as vice president of regulatory and clinical services for MED Institute. In this capacity, he has responsibility for the scientific aspects of the company’s global regulatory affairs efforts, including design and analysis of clinical studies of new technologies. Heise is a U.S. delegate to the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices and serves as convener of its working group on chemical characterization. He has been a member of the Regulatory Affairs Professionals Society since 1993, and the American Chemical Society since 1988.