Exploring approaches to decision making 11-12 June 2015, Washington DC, USA This workshop focused on identifying the other factors and influences that companies and agencies need to consider to [...]
Medicines adaptive pathways: A practical strategy to improve patient access to medicines? 1-2 October 2014, Heathrow, UK This workshop built on previous CIRS workshops in which recommendations to advance [...]
Utilisation of a common benefit-risk framework: Can it facilitate decision making and improve communication within and across agencies? 2-3 February 2015, Taipei, Chinese Taipei The aim of this workshop [...]
There have been major improvements in the regulatory environment in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) countries over the [...]
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 [...]