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Good pharmacovigilance practice
The MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries.
From 11 to 15 September 2017 I attended the PIC/S Committee meeting, Executive Bureau meeting, and Annual Seminar hosted by the Taiwan Food and Drug Administration (TFDA)
A bite sized summary of our recent posting to the MHRA Inspectorate blog
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.
The first post in this series described the importance of organisational behaviour on the success of data integrity control measures. Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.
Risk minimisation measures aim to optimise the safe and effective use of a medicinal product throughout its life cycle.
From 8 to 10 February 2017, the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland
Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners.
In the October blog post we told you about the successful audit of the GMP Inspectorate under the JAP programme. Later that month the entire Inspectorate was assessed as part of the BEMA programme.