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Post-Authorization Safety Studies (PASS)

An EU term qualifying Post–Authorization studies which include safety objectives.

Studies that qualify as a PASS are subject to specific regulatory requirements as detailed in Good pharmacoVigilance Practices (GVP) Module VIII and related addendum. The definition of a PASS from GVP Module VIII is:

“Any study relating to an authorized medicinal product conducted with the aim of identifying, characterizing or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk-management measures [DIR 2001/83/EC Art 1(15)]. A postauthorization safety study may be an interventional clinical trial or may follow an observational, noninterventional
study design” (based on secondary use of data or primary data collection).

All GVP modules can be found on the EMA website.

Mapi has specific expertise in the design and conduct of PASS, which includes the following objectives:

  • To quantify potential or identified risks
  • To evaluate risks of a medicinal product used in patient populations for which safety information is limited or missing (e.g., pregnant women, specific age groups, patients with renal or hepatic impairment)
  • To provide evidence about the absence of risks
  • To assess patterns of drug utilization that add knowledge concerning the safety of the medicinal product (e.g., indication, dosage, co-medication, medication errors)
  • To measure the effectiveness of a risk-minimization activity.

PASS could be imposed by a competent authority as a condition of marketing authorization, or after the granting of a marketing authorization if there are concerns about the risks of the authorized medicinal product or as part of a marketing authorization granted under exceptional circumstances. However, they could also be voluntary studies required in the risk management plan to investigate a
safety concern or evaluate the effectiveness of risk-minimization activities.

Imposed PASS lead the study sponsor to comply with specific requirements including but not limited to study registration and oversight of the Pharmacovigilance Risk-Assessment Committee (PRAC).

Mapi supports Marketing Authorization Holders and Investigators for the development of study protocols, the conduct of studies and the writing of study reports in accordance with relevant scientific guidance including the ENCePP Guide on Methodological Standards in Pharmacoepidemiology and the Guidelines for Good Pharmacoepidemiology Practices of the International Society of Pharmacoepidemiology (ISPE GPP).

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