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 [...]
Background: This study was built on the previous 2019 and 2021 assessments where the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) selected CIRS [...]
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 [...]
A new report from the NASEM Health and Medicine Division offers recommendations for enhancing rare disease drug development. CIRS is delighted to have been able to collaborate with NASEM [...]
“This book teaches us important lessons that we will need to consider in our collaboration work with the African Medicines Agency. I am confident that this research will be [...]
Background Globally, 7,000 rare diseases affecting 300 million people pose development challenges with small patient populations. Developing medicines for rare diseases requires innovation. Despite regulatory incentives, challenges for HTA [...]
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 [...]
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 [...]
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, [...]
Background The African Medicines Regulatory Harmonisation (AMRH) Initiative was formed in 2009 and subsequently, three regional initiatives (East African Community Medicines Regulatory Harmonisation [MRH], Southern African Development Community [SADC]/ZaZiBoNa [...]