Changes have occurred in the organisation and procedural activities of the China Food and Drug Administration (CFDA) and the Centre for Drug Evaluation (CDE). Initiatives that were designed to [...]
The assessment of benefits and harms and their relative importance for patients, industry and agencies: How should they be captured? 2-3 April 2014, Surrey, UK This workshop focused on [...]
Benefit-risk assessment in the post-approval period: How to ensure a life cycle approach to evaluating benefits and risks 12-13 June 2014, Washington DC, USA The discussion at this workshop [...]
A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the regulatory review by regulatory authorities is considered of value, [...]
The aim of the study was to evaluate the Gulf Cooperation Council (GCC) centralized regulatory review process. Regulatory review times—including submission and application dates for new active substances (NASs) [...]
As part of the ongoing study to monitor regulatory performance, CIRS has analysed the trends in new medicines’ approval between 2004 and 2013 by six regulatory authorities including Health [...]
IS THERE A COMMONALITY ACROSS THE STRUCTURED DECISION FRAMEWORKS USED BY HTA AND REGULATORY AGENCIES? 1st-2nd October 2013, Surrey, UK This Workshop was designed to bring together the various [...]
Building quality into HTA/coverage decision-making processes: What are the features of good practice in HTA? 2-3 December 2013, Heathrow, UK This workshop continued the work of the CIRS September [...]
Focus on Latin America: Building quality submission and review processes and practices - Overcoming challenges and meeting expectations 23-24 January 2014, Lima, Peru This workshop was held to discuss [...]
Implementing an internationally accepted framework for the benefit-risk assessment of medicines: How close are we to this objective? 20-21 June 2013, Washington DC, USA At the annual CIRS Benefit-Risk [...]
