The working group deals intensively with quality management in clinical research and the development of medicinal products. Technically, the focus is on the implementation of the Good Clinical Practice Guideline (GCP), but the interfaces to the neighboring GxP areas are also in scope. The working group deals with the application and interpretation of the applicable regulations such as EU directives, guidelines or drug laws. In addition, audit techniques and how to deal with inspections is discussed as well as the “day to day worries” of the auditors. The working group also prepares technical statements on national and international draft regulations.
The working group meets about three times a year at different locations for an intensive exchange of opinions and experiences. A member takes over the organization and hosts the meeting. The minutes of the working group meetings are published in the members’ area.
If you have any question to this working group please contact us.