7 November 2018
12:00 – 1:30 pm EST
This 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.)
Learning Level
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.
Learning Objectives
Upon the webcast's
conclusion, you will be able to:
- understand the factors that drive successful
study design
- approach clinical study design with an initial
understanding of when to incorporate these elements
- offer alternatives to study design when conflicts
arise between cost, speed and scientific rigor
Who
should attend?
- Regulatory scientists
- Clinical scientists
- R&D personnel
Speakers
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.