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The Qualified Person for Pharmacovigilance

For companies with products sold in the European Union, Volume 9A requires that there be a “Qualified Person for Pharmacovigilance” (QPPV or QP). This is a critical role and function within the company and is discussed in detail. The concept of a QP is most interesting. A named individual (and backup) takes corporate and personal responsibility for the functioning of drug safety and pharmacovigilance (PV) for every company that has a Marketing Authorization (MA) in the European Union. There is no direct counterpart in the United States, Canada, or most other countries. This position functions at the European Union level. Some European Union member states also have a national QP (sometimes called by a different title) with similar obligations and responsibilities for that country. This person may or may not also function as the European Union-level QP. The position and requirements are defined in Volume 9A Section 1.2. The QP must be designated (and thus a PV system in place) at the time of submission of an MA. Note that the QP is not responsible for manufacturing issues. There is a separate QP for manufacturing.

Volume 9A notes that:

• Each company must “submit a description of the pharmacovigilance system and proof that the services of a Qualified Person Responsible for Pharmacovigilance (QPPV) are in place.”
  
• The MAH should have permanently and continuously at his disposal a QPPV residing in the European Union or EEA with 24/7 availability.
  
• One QPPV per system in a company. There should be a qualified deputy also residing in the European Union/EEA. Name and contact information registered with EMEA/member states.
  
• Some member states require a named person/national QP too. This person may or may not be the same as the European Union QPPV.
  
• The QPPV should be appropriately qualified, with documented experience in all aspects of pharmacovigilance. If the QPPV is not medically qualified (i.e., an MD), access to a medically qualified person should be available.
  
• The QPPV has multiple responsibilities:
  
  
  
  • Establishing and maintaining/managing the MAH’s pharmacovigilance
    
    
    
    • Ensuring that all SARs (including literature searches) are collected, collated, and accessible at least at one point within the European Union
      
    • Ensuring that there is a Detailed Description of PV Systems in place
      
    • Preparation of ICSRs (PSURs) and company-sponsored postauthorization safety studies (PASS)
      
    • Continuous overall pharmacovigilance evaluation during the postauthorization period
      
    • Ensuring that any request from the health agency is answered fully and promptly
    
    
  • The QPPV should have oversight of the PV system in terms of structure and performance to ensure the following system components and processes:
    
    
    
    • Establishment and maintenance of a system ensuring that all SARs are collected, collated, and accessible at least at one point within the European Union.
      
    • Preparation of ICSRs, PSURs, and company-sponsored postauthorization safety studies (PASS)
      
    • Continuous overall pharmacovigilance evaluation during the postauthorization period
      
    • Ensuring that any request from the Competent Authorities for additional information is answered fully and promptly, including the provision of information about the volume of sales or prescriptions, benefits and risks, and postauthorization studies
    
    
  • Oversight of MAH’s PV system includes:
    
    
    
    • Quality control and assurance procedures.
      
    • SOPs.
      
    • Database operations.
      
    • Contractual arrangements.
      
    • Compliance data (e.g., quality, completeness, and timeliness for expedited reporting and PSURs), audit reports, and PV personnel training.
      
    • The QPPV and deputy must have a written job description and CV on file.
    
    
  • MAH Responsibilities:
    
    
    
    • Support the QPPV and ensure appropriate processes, resources, communication mechanisms, and access to all sources of relevant information in place for the QPPV.
      
    • Ensure full documentation of all procedures and activities of the QPPV.
      
    • Implement mechanisms for the QPPV to be kept informed of emerging safety and risk-benefit issues including clinical trials and contractual agreements.
      
    • Ensure the QPPV has the authority to implement changes to the MAH’s PV system to maintain compliance.
      
    • Ensure the QPPV has input into Risk Management Plans and the preparation of regulatory action in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and, as appropriate, communication to patients and healthcare professionals).
      
    • Ensure the presence of back-up procedures (e.g., in case of non-availability of personnel, AE database failure, failure of other hardware or software with impact on electronic reporting and data analysis).
      
    • MAH may transfer PV, including the role of the QPPV, to another person or organization.
      
    • The ultimate responsibility for all PV obligations always resides with the MAH.
      
    • A detailed and clear documented contract must be in place for this.
      
    • The contracted person or organization should implement QA/QC and allow auditing by the MAH.

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