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Bacterial Infections: A Guide for Regulatory Writers

Level:
Foundation
Area:
Medical Science
Code:
MSF12
Duration:
03:30:00
Workshop profile:
Experienced regulatory writers with little or no experience of the clinical development of antibiotics.
Objective:
Provide an introduction to bacterial infections and their development so that the regulatory writer feels confident in discussing the development of documents.
Content:
Starting work in a new therapeutic area is always a challenge but several factors make infection/antibiotics particularly difficult. This interactive workshop aims to demystify some of the daunting complexities that regulatory medical writers will encounter when starting out in this fascinating field. As background, the workshop will cover nomenclature and classifications, the incidence of common bacterial diseases, modes of action for common drug classes and the main mechanisms of bacterial resistance. After covering these basics, attendees will explore the practicalities of measuring resistance and then look at the key considerations for study design, conduct and reporting. Throughout, the emphasis will be on equipping the regulatory medical writer with the knowledge needed to contribute meaningfully to the development of clinical study documents.