Many marketing authorisation holders (MAHs) sponsor and run a wide variety of programmes that are often internally termed a ‘patient support programme’ (PSP) and we are often asked by industry about the expectations for the collection of safety data from these programmes.
Kiernan is a Senior Pharmacovigilance Inspector and she joined the MHRA GPvP Inspectorate in April 2012. Her background is in Quality Assurance auditing for a central laboratory providing services for Phase I-III pharmaceutical clinical trials. Kiernan has a Master’s degree in Biomedical Sciences from the University of Southampton.
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period of April 2016 to March 2017.
Risk minimisation measures aim to optimise the safe and effective use of a medicinal product throughout its life cycle.
In July 2003 the Medicines and Healthcare products Regulatory Agency (MHRA) introduced a statutory pharmacovigilance inspection programme of marketing authorisation holders (MAHs) in the United Kingdom. The revisions to the pharmacovigilance legislation implemented in 2012 are supportive of the inspection of …
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period of April 2014 to March 2015. The full metrics report is available on GOV.UK. The report concludes that in the period April 2014 to March 2015, MHRA conducted a …
The Medicines and Healthcare products Regulatory Agency (MHRA) has embarked on a recent initiative to evaluate the feasibility of conducting stand-alone inspections of pharmacovigilance contract service providers. In July 2003 MHRA introduced a statutory pharmacovigilance inspection programme of marketing authorisation …
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