If you are tinkering under the bonnet and feel you require the diagnostics approach a specialist consultancy, such as JensonR+ can help. We aid in the strategy; the maintenance by fixing faults before they become running issues and can also give you a regulatory MOT.
If you are a company or an individual wishing to promote a medicine by way of advertising, you need to ensure you know the rules of the road before you embark on this as there are many important factors to consider.
There are two words which often sit together when organisations discuss brand plans and company objectives for these, “Strategy and Tactics”. Have you however paused to consider them in full and to understand how they can guide you and what those differences are?
The page is still nearly blank for 2022 and now is the time if you’ve not already done so to sit back and reflect on what went well in 2021 and changes that need to be made for 2022. Are you going to repeat those “learnings” from 2021 or make a step change and see things possibly in a different light?
The EC Commission opened a consultation on the 31st August on Pharmacovigilance activities (Amendment Regulation (EU) 520/2012. This consultation closes on the 15th October at 12.00CET so there is not long to go to get your thoughts submitted back to them
Submission dates for 150-days assessment procedure for national marketing authorisation applications containing new active substances.
The MHRA has published its Delivery Plan for 2021-2023. Their focus is the platform of “putting patients first: A new era for our agency”. The goal of this plan is to help ensure meaningful outcomes for patients, protecting public health through excellence in regulation and becoming a truly world-leading regulator.
JensonR+ is proud to be a part of the worlds largest alliance of organisations committed to reaching a Net Zero carbon emission by 2050. We have joined the UK Business Climate Hub to help do our bit.
JensonR+ Director James Hall, looks at one of the most important meetings you can hold with MHRA - a SAM (Scientific Advice Meeting). These meetings help define a development pathway, inform MHRA of your plans and answer any questions you may have on the route being taken.
