With the move to electronic ways of working and integration of more electronic systems within a clinical trial, the MHRA GCP inspectorate has noticed that not all eSystems have been designed with the correct functionality in mind.
Mandy Budwal-Jagait is a GCP inspector with the MHRA and joined the Agency in April 2014. Mandy conducts a variety of GCP inspections in commercial and non-commercial organisations, including Phase I units registered under the MHRA Phase I Accreditation Scheme.
Prior to joining the Agency, Mandy has held Clinical Research and Quality Assurance roles in the Pharmaceutical Industry. She holds a MSc in Toxicology and BSc (Hons) in Medical Biochemistry.
Recommendations to improve safety reporting compliance so both regulator and sponsor can fulfil their obligations to protect patients
What delegates learned about improving compliance, plus the latest information on this year's event.
A look at the recently published 2018 metrics report for GCP serious breaches reported to the MHRA - and what you need to know about reporting a serious breach.
Part two of this post provides two case studies from inspections where critical and major findings have been identified in regards to Organisation’s Oversight of Clinical Trials of IMP.
The first of two posts focusing on sponsor oversight and how to improve compliance in this area.
Find out how to register for the 2018 GCP Symposium.
The annual GCP Symposium was held by the MHRA on 20 September 2016 in Birmingham and was repeated on the 21 September 2016.
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About the MHRA Inspectorate Blog
This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.