On Tuesday 7 May 2019 representatives from trade organisations, professional bodies, non-commercial organisations and other regulators and government functions involved in the analysis of clinical trial laboratory samples were invited to attend the inaugural GCP Laboratories Stakeholder Engagement Meeting (StEM) …
Good clinical practice
On 28 October 2019 the GCP inspectorate will be holding a roundtable discussion aimed at suppliers of electronic health records in both primary and secondary care (including commercial and non-commercial developers). This post details how to register your attendance for this event.
A look at the hot topics relevant to non-commercial sponsors and investigator sites on the agenda for this event on 11 September in Manchester
Whether investigator site or sponsor, what can be done to ensure EHRs are fit for purpose to make clinical trials the best they can be.
What delegates learned about improving compliance, plus the latest information on this year's event.
A look at the recently published 2018 metrics report for GCP serious breaches reported to the MHRA - and what you need to know about reporting a serious breach.
From 8 to 10 April 2019, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
Guidance on the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs
The benefits of risk assessment in clinical trial planning and how a more proportionate regulatory approach can overcome potential barriers to completing trials
Not all trials are the same in terms of risk. To support UK sponsors of clinical trials, a substantially simpler and shorter form may be submitted in lieu of a full DSUR, giving a significant time saving.