Clinical Quality Management in a Medical Department of a Multinational Pharmaceutical Company
An enhanced approach to quality
Dr. Jürgen-Hans Schmidt, Dr. Martin Gebauer, and Dr. Thorsten Gorbauch
Aventis Pharma Germany GmbH (Ein Unternehmen der sanofi-aventis Gruppe), Medical Affairs, Bad Soden (Germany)
Clinical quality assurance in pharmaceutical companies can be differently organized depending on many factors. An important issue is the philosophy in the quality assurance approach (i.e. a pure compliance vs. a total quality management approach). This paper is reflecting these two situations. The conclusion is drawn that a total quality management approach seems to be superior to a pure compliance approach.