Batch Specific Variations – are you aware of the opportunities?
Batch Specific Variations (BSVs) are one of my favourite activities to do – they are fast paced, put my regulatory expertise into action and often mitigate against potentially devastating consequences for patients – Commercial and Finance are normally quite pleased with the outcome too! I wouldn’t normally recommend reading guidance willy nilly, however I believe […]
How short-term mindsets can damage the long game
The consequences of short-term mindsets are of course not limited to Regulatory Affairs, they impact all matters of life such as health, finances and relationships to name a few. I won’t get too personal here though and will just focus on what I know I can preach best! A short-term mindset is not a new […]
The new MHRA pipeline planning process
Back in August the MHRA launched their new pipeline process to allow them to better prepare for incoming work. Fusion Pharma attended the latest webinar in September to find out all about this new process. What is the MHRA pipeline process? By requesting that current and potential MA holders provide information on planned and potential […]
How the Windsor Framework will impact Pharmacovigilance
We have unpacked how the Windsor Framework (WF) affects Regulatory activities through several of our Fusion webinars and articles, so I thought it only fair that we now explore how Pharmacovigilance (PV) activities will be impacted! You can revisit our webinars on the WF here. A quick reminder of the Windsor Framework measures: Implementation 1st […]
International Recognition Procedure for Medical Devices
Back in May the MHRA published a statement of policy intent, outlining the proposal of a new international recognition procedure for medical devices. This comes after its announcement earlier in the year detailing a roadmap for the future new UK medical device regulations, and it’s hoped that this would be implemented by the time this […]
It’s OK not to know everything in Regulatory!
Regardless of where you are in your career, you will never reach a point where you know everything. You can obviously apply this statement to most careers, however in Regulatory I believe you are more likely to have a successful career when you start feeling comfortable with this notion. An (ex)client recently said to me […]
MHRA Applications – One strike and it’s out
Earlier this year the MHRA published new guidance on established medicines, the guidance came into force on 1st March 2024. The aim of the guidance is to ensure that applications are right first time, which allows for timely processing of marketing authorisation applications for establishes medicines and applies specifically to chemical products. The main changes […]
Cost Saving in Regulatory
UK pharma companies are scrutinising their budgets more than ever before as a result of inflation, the impact of VPAS / VPAG and Brexit. With Regulatory Affairs departments being cost centres rather than a profit centre, it is only to be expected that we play our part in reviewing where money can be saved. Generally […]
How to save money in your Regulatory Affairs Department
Can you save costs in a Regulatory Affairs Department? Yes – it can be challenging to include Regulatory in company-wide cost saving goals since the majority of the work we do is unavoidable and essential to maintain the licence to sell medicines. However, there is a misconception that you can’t save costs since fees are […]
Regulatory Consultancy Vs Contractor
Navigating the challenges of workforce fluctuations and contractor reliability is familiar terrain to the Fusion Pharma team. We understand the frustrations that come with onboarding, training, and then watching a contractor move on to another opportunity. At Fusion Pharma, we’re here to redefine your experience by offering a consultancy approach that addresses these pain points […]