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 ( 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.