Pharmaceutical Medicine Teaching Syllabus for Medical Writers

Abstract

Medical writing emerged as a need to provide an operational tool for the practice of Pharmaceutical Medicine. The European Medical Writers Association (EMWA) and the American Medical Writers Association (AMWA) are offering training in regulatory writing, but a formal university training and/or continuous education programme in medical writing does not exist. Since regulatory writing is only a part of medical writing, a course that would offer training in Pharmaceutical Medicine for students would be extremely useful. Indeed, the current dearth of suitable training options was recognized by the European Innovative Medicines Initiative Joint Undertaking which selected PharmaTrain, a Master level programme for advanced studies in Pharmaceutical Medicine and drug development sciences, as one of the first projects to be granted funding. It should be noted that PharmaTrain, which was officially launched in 2009, includes medical writing components; however, the course is primarily aimed at pharmaceutical industry professionals, rather than those wishing to specialize in medical writing. Thus, the overall goal of the proposed course is to teach students the principles and practices of Pharmaceutical Medicine with applications in medical writing. The teaching syllabus for undergraduate students includes an introduction to innovative drug research, development, evaluation, use, monitoring and marketing, as well as a brief presentation of generic drugs and biopharmaceuticals. The teaching syllabus for graduates and medical students offers advanced learning in these areas and includes an extensive presentation of research orientation.