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An Overview of Healthy Volunteer Studies

Level:
Foundation
Area:
Drug Development
Code:
DDF39
Duration:
03:00:00
Workshop profile:
This workshop is for medical writers who would like to gain insight into the unique aspects of clinical trials conducted with healthy volunteers rather than patients (such as Phase 1, thorough QT, and bioequivalence studies).
Objective:
Healthy volunteer studies make up a large proportion of studies in most clinical development programmes. Medical writers working on documents for these studies need to understand how they differ from clinical trials in patients. After attending this workshop, the participant will understand the design issues and data collected in healthy volunteer studies.
Content:
This workshop will cover the following topics for healthy volunteer studies: · Key regulatory guidance documents · Populations studied · Study designs and objectives · Types of assessments Note: Phase I studies in patients will not be covered. Note: Content in this workshop was previously included in Workshop DDA18. (Medical Writing for Healthy Volunteer Studies)