Health technology assessment (HTA)
The Centre for Innovation in Regulatory Science (CIRS) held a multi-stakeholder workshop that examined current regulatory and reimbursement frameworks for rare disease products (orphan drugs), reviewing how these can [...]
Background Pharmaceutical companies have been actively taking early scientific advice from health technology assessment (HTA) agencies during development, with the aim to understand the HTA evidentiary requirements. The evolving [...]
So far 2024 has been a busy year conference wise for CIRS! CIRS staff have presented work and/or moderated sessions at several conferences including DIA Europe, RAPS Euro Convergence, [...]
Timely availability of new medicines to patients is crucial for public health. This process involves several phases: the time taken for regulatory approval, the time to health technology assessment [...]
There are an estimated 300 million people across the world affected by around 7000 known rare diseases. Challenges in bringing treatments to market for these conditions include small patient [...]
This CIRS workshop brought together companies and agencies (HTA and Regulatory) to discuss the sources of uncertainty that are being built in, by the way medicines development has evolved [...]
This multi-stakeholder workshop consisted of a series of presentation sessions and three parallel breakout discussions. Presentations explored trends in regulatory and HTA approvals of orphan products [...]
We’re thrilled to welcome Penelope Cervelo as the new CIRS Research Analyst! Penelope will work closely with Dr Tina Wang and Dr Belen Sola on HTA projects and activities, [...]
CIRS brought agencies and companies together in a workshop to discuss new ways of working and how the regulatory and HTA landscape in mature and maturing countries should evolve [...]
During ISPOR Europe 2023 in Copenhagen, Belen Sola presented a poster entitled ‘Study of HTA Timelines and Outcomes for MHRA-Approved NASs in the Post-Brexit UK via Reliance/Work-sharing Routes'. Background: [...]
