The EU GDPR (General Data Protection Regulation), effective from 25th May 2018,  replaces the Data Protection Directive 95/46/EC, is designed to harmonise the data privacy requirements across Europe, to protect and empower all EU citizens data privacy, and to strengthen the way of handling personal...

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...

The Ministry of Health and Family Welfare in India has issued the draft Clinical Trials Rules 2018. It applies to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee. It will come into force after its...

Albert Einstein:
Success = Work + Play
PharmaGCP:
Career = Knowledge + Network
Get in touch with us
info@pharmagcp.com
We work closely with you and carry out research to understand your needs and wishes.