CIRS 2023 Annual Report
We're delighted to present our latest Annual Report, which provides a summary of the projects, publications, multi-stakeholder workshops and Technical Fora from Regulatory and HTA workstreams undertaken in 2023. [...]
2024 Workshop Synopsis – What is needed for risk-based approaches to work effectively and efficiently?
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 [...]
2023 Workshop report – Review and reimbursement frameworks for rare disease products
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 [...]
2023 Workshop report – Uncertainty in the development of new medicines
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 [...]
2023 Workshop Synopsis – Regulatory and reimbursement frameworks for rare disease products
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 [...]
2023 Workshop report – New ways of working for medicines development
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 [...]
2022 Workshop report – Building on regulatory and HTA agilities for high unmet need
In 2020, coronavirus disease (COVID-19) spread rapidly around the world and halted regular social, business, and research activities. The pandemic impeded normal functioning across several fields, and businesses and [...]
2022 Workshop report – Collaborative models for regionalisation, work and information sharing: How do these fit into the regulatory toolkit?
This workshop looked at how maturing markets are building risk-based approaches into regulatory assessment, building on recent CIRS workshops in Singapore (2019) and South Africa (2018). The workshop also [...]
CIRS 2022 Annual Report
We're delighted to present our latest Annual Report, which provides a summary of the projects, publications and Multi-stakeholder Workshops, Technical Fora, Industry Discussion Meetings, and Impact Case Studies from [...]
2022 Workshop report – How has the pandemic accelerated the acceptance and utility of RWD/RWE in regulatory/HTA decision making?
This workshop builds on the outcomes of the CIRS Professor Breckenridge memorial workshop in December 2020, as well as the 2021 workshop on utilisation of digital technologies in clinical [...]