China’s Evolving Innovation Landscape: New DIA Global Forum Article
A new article authored by CIRS' Dr Tina Wang and Dr Neil McAuslane, together with Prof Jin Wang of the OmniChain Med Institute, has been published in the September [...]
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 – 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 [...]
CIRS RD Briefing 85 – New drug approvals in six major authorities 2012-2021
This Briefing presents the results from the CIRS annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food [...]
2016 Workshop report – RWD to RWE for assessing efficacy and effectiveness
Real-world data to real-world evidence for assessing efficacy and effectiveness: Opportunities and challenges for new medicines development, regulatory review and health technology assessment 23-24 JUNE 2016 TYSONS CORNER, VIRGINIA, [...]