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Home > Our Services > EU QPPV / National QPPV

EU QPPV / National QPPV

Confidence Beyond Compliance

The marketing authorization applicant/ holder shall have the necessary means to fulfil the tasks and responsibilities listed in EU Directive 2001/83/EC as amended by EU Directive 2010/84/EU.

If required, PharmaLex can take on the tasks and responsibilities of the EU Qualified Person Responsible for Pharmacovigilance, or provide a deputy in times of absence or illness. Key tasks of the EU-QPPV comprises:

  • Ongoing monitoring of the benefit and risks of medicinal products.
  • Maintenance of the Pharmacovigilance System Master File.
  • Serving as point of contact to Regulatory Authorities with 24 hours availability.

PharmaLex can also support clients with the nomination of Pharmacovigilance contact person at national level, responsible for the maintenance of the local Pharmacovigilance System, and based on the EU Member States requirements

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What our clients say

Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!

Astellas
Head of Ethics and Compliance, Astellas Pharma Europe

There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.

Large Pharma, Global
VP Regulatory Strategy

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WHAT OUR CLIENTS SAY
  • I just wanted to let you know that the recent EU Codes webinar was excellent. Rina presented a very complex and grey topic in the most clear and digestible manner – a sign of a true expert. The questions in the Q&A were sometimes a little ambiguous but Rina gave clear and relevant answers that provided real clarity.

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