PV Compliance

Pharmacovigilance Compliance
Compliance: the act of obeying an order, rule, or request.
Within Pharmacovigilance (PV) context, compliance particularly refers to legal and

regulatory guidance (e.g. GVP in the EU), but also internal (e.g. standard operating
procedures) and external (industry codices) policies.
Compliance is not about the purpose of the measure or the process; this needs to be
thought through everywhere. It is about continuously monitoring adherence, to measure
against the expected, and to document accordingly.
Five parameters (‘Key Performance Indicators’) have been predetermined for PV; these
have to be continuously monitored (GVP II.B.4.6.):
timeliness of 15-day and 90-day reporting,
quality of submitted reports to competent authorities,
timeliness of Periodic Safety Update Reports (PSURs),
timeliness of safety variation submissions,
adherence to risk management plan (RMP) commitments.
Additional parameters:
Example
The extent to which distributors or affiliates meet their obligations.
The total number of parameters should be easily manageable.
Each parameter needs to be defined clearly, i.e. what is measured, the period, methods
applied, targets, and results.
If the result doesn’t meet target (e.g. 88 % ‘in time’ case submissions, rather than the
intended > 98 %), this is to be indicated clearly, e.g. by a ‘traffic light system’. Of
course, as we are hopefully measuring the important indicators, appropriate measures
should be taken, documented, and monitored in this case.
Audits are an important tool to monitor compliance.

Measuring the compliance of a defined set of variables is key for functions like
pharmacovigilance, where there is intense reporting to different regulatory and non-
regulatory entities with strict regulations and high inspection risk.
The real objective of monitoring compliance is indeed not only checking how close the
department is to the ideal goal of 100% compliance (which is rarely met in real life), but,
more importantly, measuring the performance of the system in its ability to detect and
prevent future non-compliance situations.
A 100% compliance rate objective will often be elusive because of breakages in the
reporting chain due to situations such as:
Legal cases arriving in boxes, with hundreds or more pages to scan, read and interpret.
If the legal department has not been trained properly, this information will arrive late in the
PV department;
A letter from a customer, sent directly to the CEO, that complains of a
negative drug experience, and that languishes too many days on someone’s
desk;
Cases arriving late from partners in spite of a well-defined Safety Data

Exchange Agreement;
An overnight data dump from a regulatory authority containing thousands of
AE reports, which need to be translated, triaged, captured, coded, reviewed

and sent to partners and health authorities with impossible timelines.
Beyond compliance to reporting timelines, other quantitative or qualitative elements are
extremely relevant to verify the performance and compliance of a PV system, and to
implement corrections and improvements wherever needed. Here are some examples of
additional quantitative metrics:
Compliance from partners or other functions: capturing all deviations from established
timelines to receive cases from partners or other departments will be key to identifying the
usual culprits. Or to finding where there are weak points in the data collection system, and
determining how to act before it is too late.
Cases in danger of being late: PV databases should generate a daily listing showing
where the cases are in the workflow and which cases are reaching the threshold where the
company will not have enough time or resources to distribute the cases on time to partners,
health authorities, investigators or IRBs.
Compliance to follow-up: not adhering to the agreed follow-up process, which should be
proportionate to the nature and seriousness of the cases, would demonstrate a lack of focus
for getting documented reports and having a robust basis for signal detection activities. This
would be a critical observation during an inspection.
Compliance to agreed timelines for the interim steps of an aggregate reports preparation.
Even if these internal timelines are unlikely to be a focus during an inspection, they are key
indicators of the probability that a final report will be delivered late, and with potential
quality issues, as there may be less focus on quality in the rush to compensate for other
delays.
Compliance to PV training: it should be easy to demonstrate a constant 100% compliance

for the PV team and all relevant stakeholders, with a robust process for regular review and
update of the training curriculum.
Other quantitative and qualitative elements are good indicators of how much the organization
and its systems are actually geared to maximizing compliance. The following continuous
improvement items should also be part of the compliance dashboard:
Too many review and correction loops to complete an activity, or redoing someone else’s job
(such as outsourced activities) will end in low compliance situations. It shows sub par
allocation of resources and talent to get the job done right the first time with minimal quality
controls and corrections.
Complicated or unclear processes will likely impact the overall compliance and performance.
The PV SOPs should be clear and simple, and easy to follow and comply with.
Always looking at how to simplify and make processes easier will have a major impact on
compliance-related performance, not to mention increased job satisfaction and talent
retention.
Compliance and continuous improvement reviews deserve a specific forum in a PV
organization. A standing PV Compliance and Continuous Improvement committee,
meeting on a regular and ad-hoc basis, and driven by a Charter or SOP, is a guarantee that
the focus on compliance is there and will positively influence the compliance numbers.
All key PV functions should contribute; a participation from QA is also recommended. A

robust Corrective and Preventative Action Plan system and project management tools will
be critical. Visualization tools will help manage and communicate clearly with regard to
the performance of the group. Good documentation practices are a must.
Overall, a healthy and compliant PV organization will be the result of a continuous drive
for optimal compliance, the use of the right dashboards, a solid CAPA system and a
continuous effort to improve the performance of the activities. Reaching this state will
minimize the risk of critical observations during an inspection. It will also be a powerful
tool to communicate internally about best practices and further increase the recognition of
the strategic role of pharmacovigilance.
PHARMACOVIGILANCE INSPECTIONS :
To ensure that MAHs comply with pharmacovigilance regulatory obligations
and to facilitate compliance, Competent Authorities may conduct
pharmacovigilance inspections.
There should be collaboration between Competent Authorities to minimise

duplication and maximise coverage. Inspections will be random and systematic,
as well as targeted to MAHs suspected of being non-compliant.
The results of an inspection will be routinely provided to the inspected MAH

who will be given the opportunity to comment on the findings.
The results will be used to help MAHs improve compliance and may also be
used as a basis for enforcement action.

PV Compliance

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Pharmacovigilance Compliance

Compliance: the act of obeying an order, rule, or request.

Within Pharmacovigilance (PV) context, compliance particularly refers to legal and

Audits are an important tool to monitor compliance.

Cases arriving late from partners in spite of a well-defined Safety Data

An overnight data dump from a regulatory authority containing thousands of

AE reports, which need to be translated, triaged, captured, coded, reviewed

Compliance to PV training: it should be easy to demonstrate a constant 100% compliance

All key PV functions should contribute; a participation from QA is also recommended. A

There should be collaboration between Competent Authorities to minimise

The results of an inspection will be routinely provided to the inspected MAH

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