What are the main objectives of PASS studies for Risk Management?

Saad Shakir writes:

In this short blog and video, Saad Shakir outlines the main objectives for PASS studies and describes the characteristics of those who are able to conduct such studies:

The objectives of Risk Management Studies are essentially to reduce the uncertainties related to the limitations of pre-marketing data and examine the effects of the different characteristics of real world population who receive medicinal products after marketing.

Those who advise on Risk Management Studies and conduct them are required to:

  • Be able to select the most appropriate data source which is capable of answering the study questions.
  • Have the right expertise to conduct pharmacoepidemiological studies.
  • Know in detail what can be accepted by Regulatory Authorities (PRAC and its rapporteurs) to answer the Risk Management questions and have the operational ability to deliver results of studies to meet the timelines of Risk Management.