...the importance of sponsor oversight of clinical sites and laboratories, particularly increasing the awareness of areas of risk to clinical trial conduct. The presentation used examples from the inspections of...
...in 2014. A site of mine had been selected for an MHRA GCP inspection, where I observed the incredible work of the GCP inspectors. Following the inspection, I had a...
...of our flagship research and production site really helped us to make sure we were developing something that was within the regulatory parameters for this type of site, particularly as...
...website to secure your place The event takes the format of repeated 1-day events for GDP (11, 13 and 26 Nov) and GMP (12, 14 and 27 Nov) to accommodate...
...adjustment decisions on behalf of the investigator site. Jason raised issues we are seeing with these and the take home message of how it was important for sites to trust...
...to patient (ePRO) reported data across a number of trials; The changes had been requested by the sponsor’s data management team in conjunction with investigator site staff; Data changes were...
...unlicensed medicines coming from outside the EEA and must state that unlicensed medicines are imported from outside the EEA at this site. For full details please see our webpage Import...
...our website where we have published guidance on packaging, labelling and patient information leaflets. Here we have said that unless otherwise stated, updates to patient information leaflets should be introduced...
...business process improvement project to develop the Inspectorate SharePoint Team Site, to enable Inspectorate staff to connect with information and applications they rely on to perform their day to day...
...screen and on ‘TV cards’ dotted around the room. Another plasma screen displayed excerpts from recent GMP relevant blog posts published on this site. With the 9 February 2019 deadline...
