Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars.
Anna joined the MHRA as a Pharmacovigilance Inspector at the start of 2016. Since then, she has inspected the pharmacovigilance systems of all types of pharmaceutical organisations from large innovator firms, to small biotech start-ups, to international organisations with established generic portfolios, and everything in between.
Her career in pharmacovigilance started with processing Yellow Card reports at the MHRA in 2007 before she completed a PhD in peptide chemistry with molecular biology at University College London. Anna then returned to work in the field of pharmacovigilance at a large pharmaceutical company, before she re-joined the MHRA as an inspector.
A principle objective of both the MHRA and of pharmaceutical companies is to protect and improve the health of patients. When new information about the benefits and risks of a medicine become available it is often appropriate to make changes to the safety information for the product.
The MHRA pharmacovigilance inspection metrics for the period from April 2017 to March 2018 are now available on GOV.UK
The GPvP webpage has recently been updated to provide additional information about the current inspection process. This post provides some further information about GPvP inspectors and inspections.
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This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.
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- Pharmacovigilance inspection metrics April 2019 to March 2020
- Guidance on pharmacovigilance requirements for UK authorised products from 1 January 2021
- Reference Safety Information (RSI) for Clinical Trials- Part III
- Pharmacovigilance requirements for UK authorised products - 13 January 2021
- Post-transition: Pharmacovigilance requirements for UK authorised products - Thursday 22 October 2020