CIRS RD Briefing 58: Changing regulatory environment in Latin America
The aim of this Briefing is to review and summarise the findings from the major studies and interactions carried out by CIRS in LATAM in the last decade in [...]
2015 Workshop report – Exploring approaches to decision making
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 [...]
2014 Workshop report – Medicines adaptive pathways
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 [...]
2015 Workshop report – Utilisation of a common benefit-risk framework
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 [...]
CIRS RD Briefing 57 – New drug approvals in ICH countries 2005-2014
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 [...]
CIRS RD Briefing 56: Understanding the dynamics of China’s regulatory environment
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 [...]
2014 Workshop report – Assessment of benefits and harms and their relative importance for patients, industry and agencies
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 [...]
2014 Workshop report – Benefit-risk assessment in the post-approval period
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 [...]
Walker et al 2015 – Universal Framework for the Benefit-Risk Assessment of Medicines
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, [...]
Al-Rubaie et al 2014 – Evaluation of the Gulf centralised registration procedure
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) [...]