A variety of approaches have been developed to accelerate the regulatory review of medicines. We characterise these various expedited pathways as facilitated regulatory pathways (FRPs): regulatory pathways designed to accelerate [...]
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 [...]
In 2015, CIRS initiated a programme in Quality Decision Making with the following aims: Evaluate the current decision-frameworks and understand the characteristics of different decision-making processes Assess the quality [...]
Objective: This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, [...]
Background The science of decision making is well established, although in reality it is a mixture of science and art. What is currently lacking is research into decision making [...]
Commonality in evidentiary requirements across regulatory and HTA stakeholders 21-22 SEPTEMBER 2016, SURREY, UK Workshop objectives Discuss the progress made to align evidentiary requirements, what the drivers have been [...]
This R&D Briefing 60 summarises highlights from the Technical Forum convened by CIRS on 11 December 2015, Heathrow, UK. Forum objectives: Identify companies’ current approaches to seeking early scientific [...]
Real-world data to real-world evidence for assessing efficacy and effectiveness: Opportunities and challenges for new medicines development, regulatory review and health technology assessment 23-24 JUNE 2016 TYSONS CORNER, VIRGINIA, [...]
The last decade, 2006-2015, has seen a continuation of the convergence and general decrease in the approval times amongst six major regulatory authorities, namely the European Medicines Agency (EMA), [...]
WHAT ARE THE KEY PERFORMANCE METRICS THAT AGENCIES AND COMPANIES SHOULD USE TO MEASURE REGULATORY PROCESSES AND PRACTICES TO FACILITATE THE LICENSING OF NEW MEDICINES? 3-4 FEBRUARY 2016, KUALA [...]