Op vrijdag 8 oktober jl. vond een webinar plaats met als onderwerp “PASS”. Beide presentaties werden gegeven in het engels.

The first presenter is Stuart Harris, Astellas.

Stuart explains to us why PASS studies are being done and what types of PASS studies there are. In addition he explains the applicable (PV) requirements, whether they should be included in the Pharmacovigilance System Master File (PSMF) and how to approach PASS study audits.

PASS studies are being conducted after marketing authorization has been obtained and it can be a condition imposed by a regulator as part of a Risk Minimization Plan (RMP) or be conducted voluntarily by the Marketing Authorisation Holder. Based on these criteria the product is divided into 1 of 4 categories, which determines whether the study should be approved by the PRAC and/or national competent authority, are subject to GVP inspection and/or shall or should be entered into EU PAS register. PASS studies can be Interventional or Non-interventional (NI, e.g. data collection), which further define which regulation(s) should be followed and audited against during study conduct.   

The MHRA has begun a NI-PASS inspection programme, based on certain risk factors, in which they basically check all relevant items similarly with phase 1-3 studies.

PASS should be conducted in line with GCP in case they are interventional. In case of a non-interventional study, the protocol will define the standard with a recommendation for PASS to consider relevant scientific guidance, e.g.  Good Pharmacoepidemiology Practices, GPP.

In case the study is developed to obtain further information on a medicine’s safety, or to measure the effectiveness of risk management measures after marketing authorization it’s a PASS study.

The second presenter is Henrieke de Bie, Beyond Compliance.

Henrieke’s presentation is focused on the regulatory standards that are involved in PASS studies.

In case of an interventional study, it needs to follow Clinical Trial Legislation. In case of a non-interventional study a standard needs to be defined. In case of a non-interventional study that isn’t a PASS there are no standards defined but in case of a non-interventional PASS PV Module VIII needs to be followed and thus relevant scientific guidance such as ISPE GPP or ENCePP should be considered. Information about whether a study needs to be registered in the EU PAS register can be found for instance on the ENCePP home page. Non-interventional PASS protocols should be submitted to the PRAC or to the competent authority who requested the study if the study is executed in one country. After endorsement by the PRAC, the protocol should be sent to the competent authorities of the countries where the study will be executed. Submission requirements for other non-interventional PAS may be country specific and depending on scope.

In The Netherlands a PAS can be either “WMO-plichtig” or not. Definitions can be found on the WMO website.

Pharmacovigilance/Safety reporting requirements for PAS are described in PV Modules, including V, VI, VII and VIII. PAS   as a source of safety information should be included in the Pharmacovigilance System Master File (PSMF). Sources of safety information include data arising from study sources, including any studies, registries, surveillance or support programmes sponsored by the marketing authorization holder through which Individual Case Safety Reports (ISCRs) could be reported – see PV Module II.

From the above provided overview it is clear that before conducting a (non-)interventional PA(S)S audit it should be decided which standard(s) will be applicable and thus against which standard(s) the study will be audited. Practically an audit of a PASS is conducted similarly to any other study focusing on subject rights and safety and data integrity. The experience is that there might be 3 main challenges in PAS: costs (often less willingness to invest in PAS), GxP awareness (does staff involved have the right GxP knowledge and mindset?) and oversight (are the study execution and any vendors involved properly being overseen?).

When auditing PA(S)S similar items as other studies need to be considered and/or checked, such as, which departments are involved and who is/are funding the study, how is the CRO selected in case of outsourcing, are agreements complete and complied with and is there sufficient oversight, are safety events being reported accurately and promptly, are data privacy requirements (GDPR …) being followed still adhering to PV requirements as well and are the study files structured and archiving arranged?

Dit webinar was bezocht door 11 deelnemers.

De video gemaakt tijdens deze webinar is op het ledengedeelte van deze website te bekijken via deze link.