Human beings make mistakes regardless of their experience, intelligence, motivation or vigilance. Some people say that error is the inevitable downside of having a brain! One definition of “human error” is “human nature”. In another words, it is impossible not to make error when conducting...
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its annual GCP inspections metrics report for the 12-month period from 1.Apr.2016 to 31.Mar.2017. Of 15 sponsor inspections, all sponsors had at least one major and/or critical finding. This is higher than in the previous 12-month...
Over the last decade, there has been a significant increase in the use of electronic systems for capture and handling of data in clinical research. In order to maintain the integrity of the data created and handled by these systems, there are several requirements to...
GCP inspection findings/observations in clinical trials forming the basis for an application for marketing authorizations for new medicinal products or for extending indications to already authorized products have two main implications: Some findings point to GCP non-compliance issues affecting the safety, well-being and the rights...
During a period of one year from 2016 to 2017, the UK GPvP (Good Pharmacovigilance Practice) Inspectorate conducted 36 inspections of marketing authorisation holders (MAHs) and one inspection of a pharmacovigilance service provider. The purpose of these inspections was to examine compliance with existing EU and...
The MHRA (Medicines and Healthcare Products Regulatory Agency) UK has recently released the annual report of GCP inspection findings from 2016. A total of 10 commercial sponsors were inspected and there were 3 critical findings from 3 organisations. Critical finding 1: At the previous GCP inspection in 2013...
The FDA has maintained confidentiality agreements with European regulators (European Medicines Agency EMA) since 2003, which have allowed for the exchange of information as part of the respective regulatory and scientific process. However, the FDA and EMA could not, under these arrangements, share full inspection...
EMA recently published 2016 annual inspection report, which describes its inspection activities in 2016. The EMA GCP inspectors working group (IWG) focuses on the harmonisation and coordination of GCP-related activities at EU level. Most inspections were carried out in the EU/EEA/EFTA (42%) followed by inspections in...
