During the DIA Global Annual Meeting 2023, Lorraine Danks, Boitumelo Semete-Makokotlela, Sam Salek and Stuart Walker developed and presented a poster in which they shared the results, recommendations and [...]
Background: Despite the worldwide need for increased access to safe and effective medicines, there is a lack of innovative medicines in many low- to middle-income countries. On the African [...]
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 [...]
Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically [...]
This workshop was part of a series of global development workshops that brought together mature and maturing regulatory agencies. These workshops successively built on one another and evolved from [...]
An increasing number of National Regulatory Authorities (NRAs) are turning to reliance as a way to conserve resources, build expertise and capacity, increase the quality of their regulatory decisions, [...]
This workshop was part of a series of workshops on reliance, which continues to be an important area of focus for CIRS. It builds on the outcomes of a [...]
Background This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations [...]
This Workshop was a follow-on from that held in 2017 in Sao Paulo entitled “Facilitating the review of new medicines through risk-based evaluations: How can a stratification process be [...]
This Workshop built on previous CIRS global development workshops as well the work being undertaken by various groups in the areas of good regulatory and review practices and focused [...]
