38 Pharmaceutical Management

Abstract

AbstractClinical research pharmacists at remote research sites in low-resource nations face many of the same challenges as their colleagues in better-equipped environments but more acutely. These problems can include shortages, facility shortcomings, language difficulties, storage issues, regulatory questions, and logistical demands—from initial anticipation of requirements to the special considerations involved in handling investigational medicinal products and the ultimate disposition of biohazardous material. This chapter provides an overview of standard clinical research requirements, potential obstacles in a low-resource setting, and ways to overcome them, focusing on considerations that one might overlook when responding to an outbreak in a high-pressure, unfamiliar, and resource-constrained setting. It includes references to the most authoritative guidelines and frequently used manuals for ensuring that the pharmaceutical operation in a research program supports an expedited, scientifically and ethically rigorous research program in response to an infectious disease emergency.