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In order to bring a new medicine to the marketplace, the pharmaceutical company developing and producing it needs to have a pharmacovigilance system. One of the principal components of this system is the EU Qualified Person for Pharmacovigilance (QPPV) – a role that is required by European law and put into practice through local laws in each of the EU, EEA and EFTA countries. The QPPV is responsible for co-ordinating all pharmacovigilance activities for each marketing authorisation – there can be several Qualified Persons in a pharmaceutical company, each responsible for one or several marketing authorisations, or there could be a single QP responsible for all Marketing Authorisations. Alternatively, some or all pharmacovigilance activities can be outsourced to a specialist pharmacovigilance company.
The European Qualified Persons’ required qualifications are set out in EU directives; the legislation gives a little leeway to cover for individual circumstances where qualifications are supplemented by experience and training on the job but the bar is set deliberately high as the job itself is so vital for public safety.
As well as oversight of pharmacovigilance activities, the QP is held responsible for the manufacturing process and for verifying quality control. This role is required for the granting of marketing authorisation – authorisation from regulatory authorities to allow each product to be marketed. The necessity for a single point of contact for regulatory activities is a practical one. Pharmaceutical companies often have extremely complicated structures with different branches, divisions and subsidiaries responsible for different products and different parts of the production process on different territories. While this may be desirable for the efficient running of a pharmaceutical company it can be a regulatory headache with different subsidiary companies effectively passing the buck between themselves for responsibility over individual products. Thus the concept of a single point of contact for a marketing authorisation came about.
On the production side, the QP has to ensure compliance with manufacturing law in the country where products are made and that the manner in which the medicine has been produced is compliant both with local Marketing Authorisation regulation and with the regulations applicable across Europe where these differ from local rules. Where production is carried out in a different country and the product is imported, the QP must make sure that each batch of the product has been quality tested. As long as this product testing has been done correctly, it won’t need to have quality control done in the new country – as long as the documents of product quality control are up to date and available – so it is essential that this initial quality control is very thorough and done correctly. If the Marketing Authorisation holder then wants to market the product in a third country, the QP has to ensure that the Quality Controls are up to date, compliant and applicable.
Although the law does not require duplication of work in verifying quality control, it does require the quality control to be thorough and compliant.
The QP also has a leading role to play in the running of the pharmacovigilance department in terms of being aware of any possibly issues with the marketed product, signal detection and analysis of potential new issues, expedited reporting of any serious adverse events to the regulatory bodies and being available to answer any requests from regulatory agencies.
