Articles
13.10.2025
Surrogates Under Scrutiny: Proving the Link to Out...

Surrogate Endpoints in HTA Decision-Making The need to stay ahead of competitors and offset losses f...

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Articles
08.10.2025
Orchestrating Evidence Needs: Overcoming Regulator...

Optimising evidence generation in trial design, while navigating regulatory and local payer requirem...

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Guide
08.09.2025
The BRAVE Approach: Your Guide to Early Payer Scie...

Successfully navigating early payer scientific advice whether through Joint Scientific Consultations...

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Articles
08.09.2025
The JCA is here – are you generating the right e...

Five success pillars — your JCA evidence-generation checklist  From 12th January 2025, the Eu...

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Articles
20.08.2025
Reassessing Clinically Meaningful Differences in A...

The recent Medicines and Healthcare products Regulatory Agency (MHRA) approval of the Alzheimer’s ...

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Articles
11.08.2025
Why your PICO strategy matters to successful JCA 

The Joint Clinical Assessment (JCA), a core feature of the Regulation (EU) 2021/2282, aims to stream...

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Articles
14.07.2025
Engaging Stakeholders: The Power of Patient and Cl...

Decisions regarding National Institute for Health and Care Excellence (NICE) appraisals are not made...

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Articles
07.07.2025
NICE 2025 Update: How New Appraisal Reforms Impact...

The National Institute of Health and Care Excellence (NICE) has published several updates and releas...

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Articles
30.06.2025
Avoiding pitfalls: Top 5 reasons NICE HST/STA subm...

Most pharmaceutical products hoping to launch in the UK will be assessed by NICE as a Single Technol...

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Articles
25.06.2025
Mastering NICE submissions: The three pillars for ...

Securing a positive recommendation from the National Institute for Health and Care Excellence (NICE)...

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