Pharmacoepidemiology, Drug Safety & Pharmaceutical Policy

Full course description

When a new medicine is granted a marketing authorization, its clinical safety profile has been assessed based on the results from randomised clinical trials (RCTs). The number of patients recruited for these pre-marketing (Phase-III) trials (in general up to 3,000), is able to detect adverse events that occur with frequencies of up to 1:1000 patient-years. Therefore, it is difficult to assess adequately the risk/benefit profile of a drug for regulatory authorities, such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The authorities will ultimately decide whether a drug can remain on the market, whether its use will be restricted to certain subgroups of patients or whether it will be entirely pulled off the market. This problem is further enhanced by exclusion criteria for patients enrolled in RCTs, and their short duration of follow-up (generally several months up to 2-3 years). The intake of other medications or inclusion of children, elderly or pregnant women- such as in a real life setting - is often not allowed in RCTs. As a result, the EMA and FDA usually request pharmaceutical companies to conduct so called post-authorisation safety (PASS) studies. Similar studies are also conducted by other stakeholders such as academia or drug regulators such as the FDA.

This course will give an overview of the lifecycle of drug development, with a strong emphasis on pharmacoepidemiology in Phase IV research. It will evaluate stakeholders, legislation scientific methods and commonly used data sources to assess the risk-benefit profile of drugs after market authorisation.

The final assessment for this course is a numerical grade between 0,0 and 10,0.