The rumours are still out there about not talking to regulators: they will “just say no”. It’s such a shame we are still hearing this, particularly about the use of complex innovative trial designs, such as basket and umbrella trials, …
Here at the MHRA's Information Processing Unit we are getting to know our newest colleagues –five robots called Alpha, Bravo, Charlie, Delta and Echo. While our robots don’t need tea breaks or have a social life outside of work, we …
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 …
We are delivering cutting-edge technology to improve processes, introduce automation and enhance customer services throughout 2018. Our Information Processing Unit is in the middle of a four-year reform programme designed to improve its services, operations and overall efficiency while …
MHRA regularly consults its stakeholders on many issues. As Head of Economics I use the consultation responses to gather new evidence to see if we’ve got our policy right, or if we need to change it. It is extremely satisfying …
When updating product licence details, there are always areas in the variation submission processes (both National and Mutual Recognition (MR)) which can cause validation issues or the generation of Notification with Grounds (NWG) letters, ultimately resulting in a rejection or …
Our customers have been asking us for years to move to paperless communications following submissions. With old systems and processes with long delivery timescales for change and underlying poor data quality, this was not a simple task.
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