Are you keeping up with the evolution of the QP role?

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 may 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.

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Are you keeping up with the evolution of the QP role?

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