Author: Thuy Larsen

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...

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...

We are using eTMF (electronic Trial Master File) more and more in clinical trials, but the sponsor eTMFs are not always met the requirements by the inspectors, which resulted several recent inspection findings. Here are 7 recommendations for how to ensure inspection readiness of eTMF. Prior to...

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