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 [...]
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, [...]
The aim of this study was to examine the views and experiences of the Gulf Cooperation Council (GCC) states and pharmaceutical companies to identify the strengths and weaknesses of [...]
How is the value proposition driving the development and reimbursement process in major markets? What are the strategies and practical steps companies can take in development? 2-3 December 2014, [...]
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 [...]
What is the patient’s role in informing the decision process for approval and reimbursement of new medicines? 7-th October 2015, Windsor, UK This workshop built on CIRS workshops on [...]
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 [...]