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Risk Based Inspections for good pharmacovigilance practice

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Recently in the UK there has been a move towards risk-based inspection programmes.  The scope, frequency and depth of MHRA pharmacovigilance inspections are now based on an assessment of the activities  undertaken by the company to comply with the regulations. It is often the notice of a forthcoming inspection which can trigger a compliance assessment rather than implementing a continuous compliance programme.

The risk-based inspection process was implemented on 1st April 2009 and uses information provided by Marketing Authorisation Holders in a compliance report, together with MHRA information on previous inspection history  to ascertain the company‚Äôs overall control of its risk. Marketing Authorisation Holders are advised that failure to submit a completed report will be assessed as a high-risk answer to all questions.

Wainwright Associates have experts at hand to help companies monitor compliance.  Our consultants can work with your company to plan and implement a compliant pharmacovigilance system which will best your organisation. If you are reviewing your system, setting up a system, or are due for inspection in the near future and would like to speak with one of our consultants, please contact us on +44 (0)1628 530 554 or email Visit

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