Last time I wrote was just before we headed to Washington DC for the 25th Session of the International Medical Device Regulators Forum (IMDRF), hosted by the US Food and Drug Administration (FDA). The first two days were a workshop …
The global fight to eradicate polio is one of the most successful public health stories in recent years. Polio was once one of the most feared childhood illnesses in the world. It can be contracted at any age, but it …
Today we honour clinical trial professionals globally and volunteers who take part in clinical research Clinical Trials Day is celebrated around the world to recognise the day that James Lind started what is often considered the first randomized clinical trial …
This is the third blog in this series on novel trials, following an initial update on clinical trials and a second on a survey that was launched in December 2019. The survey is now closed, and thank you to everyone …
Physiological changes in a woman’s body during pregnancy can change how quickly a medicine is distributed and eliminated from her body. This can affect plasma drug levels and how well a medicine works. Understanding how and when these changes occur …
March 19th saw the third variations masterclass & workshop (a repeated, single day event) conclude with an overall attendance of 143 delegates from 104 companies. Presentations were held in the morning covering the submission of variation procedures involving Patient Information …
MHRA Variations Masterclass and Workshop - Third Date Added On 25 September Licensing Division held a single day event, (to be repeated on November 24), with presentations on the submission of variation procedures in the morning and two workshops (quality and …
Earlier this year, I mentioned we are planning events aimed at helping applicants submit that all elusive “ideal” data package and reduce deficiencies during assessment, to reduce the number of ‘Notification With Grounds’ (NWG) letters generated. We can now announce …