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What Medical Writers Contribute and What They Need to Know


Wed, Jun 26 11:45AM
W 22


What Medical Writers Contribute and What They Need to Know

Abstract Summary

Various databases (PubMed, Eric, ECONlit, Hubmed, Global Health, FDA, EMA, Health Canada) were searched to determine the extent to which the discipline of regulatory science and its communication through medical writing is documented. Introduction: Accurate and consistent measurement, interpretation and reporting of all data from clinical trials and post-marketing reports are critical for public safety. Regulatory writing involves a myriad of guidelines from regulatory agencies throughout the world, as well as professional guidelines from professionals interested in harmonizing methodologies for scientific research and reporting results. Those results are used by physicians for prescribing, public policy makers for formulary decisions and pharmaceutical companies for evaluation of existing labeling and marketing judgments.

Poster Presenter

Barbara J. Stephenson
MSc, RN,
BJ Stephenson Consulting
United States

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