A new European Medicines Agency (EMA) guideline on Good Pharmacovigilance Practices (GVP) came into effect on 8 November 2018, providing recommendations for pharmacovigilance in paediatric populations. Adverse reactions to medicinal products in the paediatric population need specific evaluation, as they may substantially differ - in terms...
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...
Unlike the situation for new drugs, it is not necessary to conduct clinical trials for every new medical device before it is approved and marketed. This depends on the device classification. Although each country or region defines the device classification in somewhat different ways, they each...
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...
The MHRA GCP Inspectorate Symposium was held recently in Leeds, UK. There was an extremely positive atmosphere and great opportunities to discuss with the inspectors during the day. The topics covered included quality systems and effective CAPA, computer system validation, handling of safety data and reference...
