Recommendations to improve safety reporting compliance so both regulator and sponsor can fulfil their obligations to protect patients
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.
Post-transition: Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 22 October 2020. This webinar was part of a series of EU Exit and post-transition guidance webinars.
The need for vigilance and diligence when conducting bona fide checks is integral to protecting the legal supply chain of medicines. What to look out for and how to report any suspected fraudulent activity
Updated guidance is now available to assist trial sponsors in building resilience into new and ongoing trials during the continuing pandemic.
Investigations are an inevitable aspect of any manufacturer’s or wholesaler’s operations. We share some common issues seen at inspections so you can consider your own company’s systems and practices and improve investigation outcomes.
During this period where MHRA has been conducting predominantly remote inspections, we have reflected on some of the common factors in critical deficiencies we have been seeing in control strategies for cross contamination between products in shared facilities.
A look at the Serious Breach data for 2019 plus details of update to the notification form and guidance documents
On 23rd March 2020 MHRA I published a post outlining changes to MHRA’s GxP inspection programme during the COVID19 outbreak. This enabled industry and the NHS to focus on medicine supply and delivery of healthcare in support of the COVID-19 pandemic
Quality Risk Management (QRM) is a requirement of Good Distribution Practice (GDP). It underpins good design and maintenance of a GDP quality system and provides an approach that enables the quality system to be safe for patients, efficient and effective through identification of risks, and facilitates proportionality of mitigation.
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