After a drug has been launched on the market, the pharmaceutical company is required to provide the licensing authorities on a regular basis with a report on the benefit-risk relationship in the use of the drug so that the licence will be extended. In the report the relationship between usage of the drug in the time interval and side effects which have become known are documented. Generally such data are gathered in the first years after licensing in so-called Post-Marketing Surveillence studies (PMS studies) which usually involve several thousand patients.
Planning, organization, carrying out and evaluation of PMS studies
Preparation of final reports of external PMS studies
Preparation of publications of the results of internal and external PMS studies
Preparation of reports for licensing authorities