News & Views

We are delighted to welcome Dilyana to the Fusion Pharma team as our newest Regulatory Affairs Consultant. Dilyana joins us with extensive experience gained across

Part of a successful regulatory strategy is to assess all available routes to licensing medicines and select the most appropriate option by carefully weighing the

ePIL plans are progressing in both the UK and the EU. The aim is to make medicines information easier to access and easier to use,

I still vividly remember my days at the MHRA – reviewing countless dossiers, applications, and cover letters under tight timelines. Sifting through complex justifications, tables,

Earlier this month, the Fusion team stepped away from our desks for one of our regular Fusion Days, which take place several times a year.

New Clinical Trials Regulations Guidelines The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 represent the most significant overhaul of UK clinical trials regulation

A tool we use to assist, not a substitute for expertise Artificial intelligence is becoming part of everyday working life across regulated industries. At Fusion

The World Health Organisation (WHO) is an agency within the structure of the United Nations (UN), formed in 1948 to coordinate international efforts to tackle

We are delighted to welcome Aidan Roberts to the Fusion team. He has quickly settled into his new role, bringing fresh energy, a thoughtful approach,

We’re thrilled to welcome Natasha Long to the Fusion Pharma team as a Senior Regulatory Consultant! Like many in the industry, Natasha didn’t set out

Just to clarify, I’m not talking about life threatening risks such as swimming with sharks (I have no desire to do this!), I’m talking about

As a regulatory professional you may be on the edge of discussions concerning VPAG, you may have heard of it but don’t really understand what

Batch Specific Variations (BSVs) are one of my favourite activities to do – they are fast paced, put my regulatory expertise into action and often

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

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

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

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

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

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

UK pharma companies are scrutinising their budgets more than ever before as a result of inflation, the impact of VPAS / VPAG and Brexit. With

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

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,

The International Recognition Procedure (IRP) has featured in every one of our newsletters since Fusion Connect went live in 2023 – with IRP being in

In our last newsletter we introduced you to InFusion, our new membership designed to support Regulatory Affairs Departments and professionals within the UK. Over the

Artificial Intelligence (AI) isn’t just a concept of the future – it’s a pervasive force shaping our everyday lives. From the personalized recommendations on streaming

This is a joint article, written by two of Fusion Pharma’s Senior Regulatory Consultants. The first part is written by Dr Lorraine Marsh from a

Artificial intelligence (AI) has emerged as a game-changer for the pharmaceutical industry, revolutionising drug discovery, development and personalised medicine. With its ability to analyse vast

2023 has been an immensely successful year for Fusion Pharma, for which we are very grateful. Our clients have hugely benefited from our experienced and

The reflection of 2023 is an excellent segue into looking at what 2024 will bring – and in a word it will be ‘InFusion’. InFusion

2023 has brought us two further ‘Brexit hangovers’… the International Recognition Procedure (IRP) and the Windsor Framework! Fusion Pharma have been closely monitoring the Medicines

Has Australia got it right? By prohibiting all varieties of vaping devices, and making them only available on prescription, Australia appears to have gone much

Since leaving the EU, the MHRA has had to adapt to new ways of working with less resource, leading to unprecedented delays in assessment timelines.

The Windsor Framework was announced 8 months ago, leading to Regulatory Affairs professionals across the UK to drop their jaws in disbelief, for this meant

Did you know we sponsor an inclusive youth team on the South Coast?   The Berewood Panthers Pan-Abilities Football Teams (U11s and U16s) meet on

Accession to the CPTPP On the 16th July 2023 the UK officially signed into the treaty confirming the UK’s accession to the Comprehensive and Progressive

We all know about the European Commission Decision Reliance Procedure (ECDRP) and that it has been extended to 31st December 2023. What my article will

We can’t issue a Regulatory newsletter without referencing The Windsor Framework, can we! On 28th February 2023, the EU and the UK agreed a deal

For as long as I can remember in my pharma career, there have always been challenges in enabling development of paediatric medicines. However, significant steps