Qualified Persons for Pharmacovigilance (QPPV)

In order to receive licence approval and be able to market medicinal products in the European Union (EU)/Europe Economic Area (EEA), Market Authorisation holders are required to have in place a Qualified Person for Pharmacovigilance. This is a very demanding role with many specific requirements that need to be fulfilled (ref: Volume 9a of the Rules Governing Medicinal Products in Europe).

AKOS provides clients with a comprehensive QPPV and deputy QPPV which fulfils all legislative requirements.

QPPV overview

AKOS QPPVs are fully experienced in the roles and responsibilities of EU/EEA QPPV which involves:

• Establishment and maintenance of the Market Authorisation Holder’s (MAH’s) pharmacovigilance system (including the preparation of safety reports, receipt and processing of adverse events, signal detection and risk minimization activities and associated procedural documents)
• Ongoing safety monitoring of the MAH’s marketed products and the management of emerging safety issues and concerns
• Contact person to the Competent Authorities on a 24 hour basis for any safety issues and concerns and also for pharmacovigilance (PV) inspections
• Residency within the EU/EEA and being appropriately qualified

QPPV role during Market Authorisation Application

MAH’s are required to submit details of their QPPV and PV system at MAA filing within the EU/EEA.

At this stage AKOS QPPVs can assist with:

• The provision of the named QPPV and deputy QPPV for your MA application
• The development of the detailed description of the pharmacovigilance system (DDPS)
• Gap analysis and development of an appropriate PV system and procedural documents, such as standard operating procedures (SOPs)
• Establishing the required local Responsible Person for PV infrastructure in accordance with applicable national legislation within the EU/EEA

QPPV role after Market Authorisation Approvals

Once an MAH receives product approval, AKOS QPPV would then perform the required QPPV roles and responsibilities:

• Ongoing oversight of the PV system in terms of structure and performance and to ensure appropriate collation of suspected adverse reactions, preparation of relevant reports i.e. Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs) and company sponsored Post-Authorization Safety Study (PASS) reports
• Conduct of on-going pharmacovigilance evaluation during the post authorization period
• Ensuring that any requests from the Competent Authorities (CAs) are answered fully and promptly
• Provision to the CAs with all information considered relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on post-authorization studies and other sources

QPPV role in Audits/Inspections

As well as QPPV involvement in company PV Regulatory inspections, our AKOS QPPV group can help with PV audits of third parties such as distributors and co-licensors to assess that they have the necessary infrastructure to comply with adverse event reporting requirements

Training & Consultancy services

At AKOS, the QPPV Group can also provide a variety of additional services such as:

• PV training of company employees and PV department personnel
• PV audit and inspection training
• Consultancy services covering:
  • PV SOPs and other procedural documents preparation
  • PV system description documents (i.e. DDPS and SPS) development
  • PV audits