The QPPV: An Essential Guide to the Qualified Person Responsible for Pharmacovigilance

May 30, 2024

When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the applicant’s Pharmacovigilance system is part of the MAA and that way the MAH also proofs that it has at its disposal a Qualified Person Responsible for Pharmacovigilance (QPPV). Already here, it is evident that the QPPV is central to this system.

Guidance from Legislation

The requirements and responsibilities of an EU QPPV are laid down in EU legislation article 23 of regulation (EC) No 726/2004 and article 104 of Directive 2001/83/EC as amended by new PV Regulation /EU) No 1235/2010 and Directive 2010/84/EU. The QPPV is responsible for all aspects of PV for the products with Marketing Authorisation (MA) within the European Economic Area (EEA) and Northern Ireland and needs to reside in the EU/EEA.

For all UK MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the MAH must have permanently and continuously at its disposal a UK QPPV who is responsible for the establishment and maintenance of the UK pharmacovigilance system. The UK also accepts an EU QPPV to serve as the UK QPPV. In the situation where the UK QPPV does not reside in the UK, a UK LPPV is required..

The QPPV can be MAH's own employee or a contract employee, as long as QPPV is continuously at the disposal of MAH.

Roles and Responsibilities of the QPPV

The main responsibilities of the QPPV are the establishment and maintenance of the marketing authorization holders PV System and to have overview on the safety profile of the medicinal product. Grouped in these two categories legislation lists much more and detailed responsibilities which include but is not limited to the below:

Overview of PV System and Safety Product Profile Related Responsibilities

PV System related responsibilities

Safety Product Profile related responsibilities

Authority to influence the performance of the quality system and the PV activities

Overview on medicinal product safety profile and emerging safety concerns

Promote, maintain and improve compliance

Awareness of the marketing authorization s commitments related to the safety of the product

Access to the PSMF

Awareness of Risk Minimisation Measures

Be in a position to verify information within the PSMF

Authority over the content of risk management plans

Receive schedules of PV audits and can trigger such audits

Sign-off of protocols of post-authorisation safety studies

Receive outcome of regular reviews of the MAHs quality system incl. corrective and preventive actions

Awareness of post-authorisation studies requested by competent authorities

Receive compliance information

Ensure submission of all PV related documents

Obtain information from the safety database

Ensure quality, correctness and completeness of PV data submitted

Be involved in due diligence process as early as possible, e.g. for acquisitions

Ensure full and correct responses to safety related requests from competent authorities

Determine what PV data shall be exchanged in contractual arrangements, e.g. SDEAs/PVAs

Provide any other information relevant to the benefit-risk evaluation to the competent authorities

Act as a single PV contact for competent authorities on a 24/7 basis

Provide input into preparation of regulatory action response to emerging safety concerns

Responsibility for the pharmacovigilance system means that the QPPV has oversight over the functioning of the system in all relevant aspects, including its quality system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance).

The QPPV may delegate specific tasks, under supervision, to appropriately qualified and trained individuals and teams, provided that the QPPV maintains system oversight and overview of the safety profiles of all products.

Thus, the EU/EEA QPPV role is not only critical to meeting the legal obligation of the MAH, but it is also an important component of the PV system to ensure patient safety and smooth business operations.

The QPPV – Position in the Centre of Different Cross Functional Teams

Cross-functional collaboration in pharmacovigilance is critical to ensuring that product safety issues are identified and addressed accordingly. The QPPV is in a very unique situation by being involved with several different functional teams and forums for all the medicinal products in the given pharmacovigilance system. The QPPV is the key person to support the cooperation and information flow between the different teams.

Examples of different teams, and their roles in PV system:

  • Management – Important is that the QPPV shall have sufficient authority to influence the performance of the quality system and the pharmacovigilance activities [IR Art 10(2)] and to promote, maintain and improve compliance with the legal requirements [IR Art 2(1)(a)]. QPPV shall have direct reporting line to the management.
  • Safety Science / Risk-Benefit/ Medical team - An overview of medicinal product safety profiles (signal management) and any emerging safety concerns. Development of PSURs and RMPs together with medical writing.
  • Medical writing - Coordinates and prepares PV documents (PSURs, RMPs, DSURs, etc.) for the applicable teams for give input, review and approve.
  • Clinical Study teams - Management of post-authorization studies.
  • Regulatory team - Authority communication, submissions, responses to Regulatory Authority requests.
  • Case processing - Collection and processing of ICSRs. The establishment, validation, and management of the Pharmacovigilance database.
  • PV operations (agreements, vendors etc.) - The QPPV is notified of and when needed involved in the relevant due diligence activities (e.g. organizational changes, mergers, acquisitions, new products, and service providers) and their potential for impact on the functioning and performance of pharmacovigilance system.
  • QA - GVP compliance - Audits in relation to pharmacovigilance system, compliance monitoring and CAPA management.
  • Sales and marketing - Product marketing status, aRMM implementation.

The QPPV Oversight

One of the most important responsibilities of the QPPV is to gain oversight and governance of the PV system, including performance monitoring and role of the QPPV. Usually, it could relate to some specific aspect of the PV system, e.g. aRMMs, clinical trials, vendors, and agreements. MAH is responsible to support and empower the EU/UK QPPV by means of documents, processes, communication mechanisms, resources, and access to all sources of relevant information to ensure the QPPV can fulfill responsibilities and gain overview of the PV system.

Examples of the ways to enhance the QPPV oversight are:

  • Proper handover / initial training of QPPV to the PV system / products
  • Training of staff of the QPPV role and requirements
  • PSMF - keeping the PSMF up to date and having appropriate frequency for the regular updates
  • Meetings with minutes - Adding QPPV to different functions' applicable meetings is easy way to pass information to QPPV. The QPPV could be ad. hoc or permanent member of the team, but always getting the minutes. If needed QPPV can raise an issue or take information forward to another department.
  • Reports - Providing QPPV different regular reports, e.g. the ICSR submission compliance, aRMM implementation, XEVMPD related compliance, deviations and CAPA progress, training compliance metrics for all PV staff and status of Periodic Safety Reports.
  • Access to the applicable databases, trackers, folders - That way it is guaranteed that the QPPV has up-to-date information available at all times.
  • Listing of all PV documents that needs to be reviewed / approved / signed by the QPPV (e.g. RMPs, PSURs, post-authorization safety study protocols and amendments).

Key Insights into the QPPV Role

The QPPV is the key person to implement and maintain the PV system and oversee the benefit risk profile of your products. As a key interface within the marketing authorization holder’s cross-functional team, the QPPV helps to bring a product to the market and keep it on the market.

Apart from oversight, the QPPV consults the marketing authorization holder on commitments towards health authorities, Risk Management Plan, risk minimization activities, Safety Data Exchange Agreements, Post Authorisation Safety Studies, and much more.

ProPharma has a well-established QPPV office team including 20 QPPVs available. If you need a QPPV to support your products, contact the team at ProPharma today and tell us how we can help.

Authors

Susanna Heinonen

Susanna Heinonen

EU/EEA QPPV

Thomas Chatzopoulos

Thomas Chatzopoulos

Vice President, QPPV Office

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