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, …
The Variation Classification guidelines list approximately 350 different types of variation change codes and classification sub-categories. These variations fall under three possible procedure types: TIA, TIB or TII and cover the active substance and finished product, devices and safety, efficacy, …
For a number of years now we have been working with the HRA (Health Research Authority), and in partnership with the Devolved Administartions of the UK, behind the scenes to explore opportunities to improve the services we provide to Clinical …
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 do not need tea breaks or have a social life outside of work, …
Several variations have a direct or consequential impact on the product information of a Marketing Authorisation (MA), by introducing changes to the SmPC and fragments, labelling and Patient Information Leaflets (PILs); these variations have a range of submission requirements …
Don’t worry, we’re not talking Shakespeare and it’s ‘B’ for baselines – we want to help you understand when a baseline might be required and what it should contain. From January 2019 the EU eSubmissions Roadmap will mandate the use …
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 …
Administrative changes can be either Type 1A or Type 1B and are considered minor variations. These include company name, postcode and/or address changes, the removal of redundant sites, and drug substance name changes. Additionally, changes can include ‘Quality Review of …
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 …
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