Saturday, 5 November 2005: 16.00-17.15
METM 05, Barcelona, Spain
Medical writing in the regulatory environment: a brief overview
Ben Young of Young Medical Communication, Madrid, Spain, is a former president of the European Medical Writers Association (EMWA)
The role of the medical writer is varied. A quick glance at the “Jobs
Available” section of the website of the European Medical Writers Association
(www.emwa.org/Workavail)
will reveal that the expectations placed on medical writers can range from specialized
editorial services to data interpretation, drafting of original text and management
of review processes and personnel, and more. The types of documentation that
medical writers produce are also diverse. For example, the tone, content and
presentation of a journal article differ from those of a clinical study report,
and medical writers are usually expected to know that difference. This presentation
will focus on client needs in the regulatory environment that a large proportion
of medical writers must deal with on a daily basis. This includes an overview
of the Common Technical Document and some specifics on reporting clinical studies
according to ICH guidelines.