Workshop Report – Vaccine regulatory and funding approaches
Over the last four years there has been much greater attention paid by industry, regulators, health technology assessment (HTA) bodies and the general public to vaccines for a range [...]
Over the last four years there has been much greater attention paid by industry, regulators, health technology assessment (HTA) bodies and the general public to vaccines for a range [...]
The Regulation (EU) 2021/2282 on health technology assessment (HTAR) reflects a significant step towards harmonising the clinical assessment in HTA decision making across EU Member States. It aims to [...]
In this workshop, CIRS brought together senior representatives from the international pharmaceutical industry, regulatory agencies, National Immunisation Technical Advisory Groups (NITAGs), HTA agencies, payers and academia to identify challenges [...]
In this workshop, CIRS brought together senior representatives from HTA agencies, pharmaceutical companies, payers and patient organisations to discuss their readiness for the EU HTA Regulation (HTAR) being applied [...]
Faced with increasingly complex technologies and novel evidence generation techniques, regulatory agencies are being challenged to work in new ways. There is pressure on them to be agile and [...]
In this workshop, CIRS brought together senior representatives from regulatory agencies, pharmaceutical companies and academia from 18 countries across the Americas, Africa, Asia and Europe, to examine risk-based approaches [...]
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 [...]
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 [...]