Where to meet CIRS – upcoming conferences
We're pleased to be involved in the following conferences coming up in the first half of 2022. Please do come and say hello! 14-16th [...]
2021 Workshop report – Regulatory, HTA and payer interactions and collaborations
Over the last five years, regulatory and HTA interactions, as well multi-HTA and multi-regulatory interactions and collaborations, have evolved in thinking and mutual activities both at a product level [...]
2020 Workshop report – Reimagining regulatory models
As the regulatory landscape changes to meet new challenges, such as increasingly sophisticated medical innovations, fundamental questions are being raised: What is the role of a ‘modern’ regulator today? [...]
Comparison of the registration process of Zimbabwe with Australia, Canada, Singapore and Switzerland
Background: Benchmarking regulatory systems of low- and middle-income countries with mature systems provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving patients’ access [...]
Seeking early scientific advice from HTA agencies
There is a growing trend for pharmaceutical companies to seek scientific advice on drug development from a Health Technology Assessment (HTA) perspective, to improve the efficiency of their studies, [...]
Regulatory-HTA decision-making interface: what the medical writer should know
For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine [...]
Review models and timelines in the Southern African Development Community
Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited [...]
Good Review Practices in the Southern African Development Community
Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to [...]
Strategies for regulatory alignment in Southern Africa
As part of the Optimising Efficiencies in Regulatory Agencies (OpERA) programme, CIRS has been working closely with six regulatory agencies in the Southern African Development Community (SADC) to evaluate their [...]
2021 Project report – Monitoring implementation and adherence to ICH guidelines
Background: This study was built on the previous 2018/2019 assessment where ICH selected the Centre for Innovation in Regulatory Science (CIRS) to collaborate on the development and the conduct [...]