Trial master file (TMF) plays a key role in the successful management of a trial by the investigator/institutions and sponsors. The essential documents and data records stored in the TMF enable the operational staff as well as monitors, auditors and inspectors to evaluate compliance with the...
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...
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...
In March, the UK and EU negotiating teams reached agreement on the terms of an implementation period that will start on 30 March 2019 and last until 31 December 2020. During this time, the UK will no longer be a Member State of the European...
The European Medicines Agency (EMA) has issued a draft guideline, which lays down the principles for management of the IMP (investigational medicinal products) by the sponsor for use in a clinical trial in accordance with GCP and GMP. The guideline is currently available for public consultation...
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...
At its meeting in London, UK, March 2018, the EMA Management Board was informed about progress in the development of the EU portal and database. Based on the experience with this complex development so far, the developer has submitted a revised project plan with improved project...
European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance on 22.Nov.2017. EudraVigilance is the European system for monitoring the safety of medicines. It facilitates electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the...
Guideline outlines strategies to identify and mitigate risks for trial subjects The finalised guideline – issued on 20 July 2017 – will take effect on 1 February 2018. The European Medicines Agency (EMA) has revised its guideline on first-in-human clinical trials to further help stakeholders identify and...
