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MHRA Inspections of CROs

24/1/2012

In accordance with the provisions of the new pharmacovigilance legislation, as per Directive 2010/84/EU, EU Competent Authorities may inspect the premises and pharmacovigilance records of both Marketing Authorisation Holders and companies employed by them to perform pharmacovigilance services.

In the UK the MHRA is proposing to establish a scheme to carry out such inspections of service providers. Wainwright Associates’ experienced pharmacovigilance consultants are able to conduct independent audits to enable service providers to prepare for this eventuality.
For further information regarding audits and inspections, please contact us on +44 (0)1628 530554 or email enquiries@wainwrightassociates.co.uk.