​Much expectation, and responsibility, has been put on the shoulders of the Qualified Person for Pharmacovigilance (QPPV).  The dedication and commitment to the role has, in many organisations, established good oversight of operational processes across pharmacovigilance e.g. QPs have a Detailed Description of the Pharmacovigilance System (DDPS) in place to support the submission process, and operational metrics to ensure compliance to Regulatory requirements. 

However, the role has not been fully defined, and its scope is developing as Regulators are pushing towards more enforcement and focus on proactive safety, which in turn is putting more burdens on the legal role of the QP.  The role is a continuing evolution, and now is the time to ensure compliance with both immediate and expected requirements of the QP.

Nostrapharmus says: "The publication of Volume 9A - Pharmacovigilance for Medicinal Products for Human Use (April 2007) has certainly made a big impact on the role of the QP.  It has clarified the role and specified the areas for which a QP has oversight responsibility and those for which it has direct responsibility."  Nostrapharmus predicts that not all companies will grasp the full implications of 9A in establishing the role of the QP and the processes needed for them to succeed.  The idea of a single point of accountability requires a radical rethink of governance across functions, competency requirements, reward and recognition, and career paths.  Only by taking this holistic approach can the QP be set up to succeed.  Some companies will 'get it' from the start, others will respond only after 'prompts' from the regulator.

To read the article in full, please click on the pdf link below:

Are you keeping up with the evolution of the QP role.pdf

or to read the magazine, please click on the link below, the article can be found on page 66:

http://viewer.zmags.com/showmag.php?mid=wqrgrw#/page66/

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