This workshop was a follow-on from a collaborative forum held in Utrecht in 2018 entitled What new research can enable a joint approach by regulatory and HTA agencies to [...]
The aim of this workshop was to bring together companies, patient representatives and HTA, payer and regulatory agencies to discuss current perspectives and opportunities for Facilitated Regulatory Pathways (FRPs) [...]
This Workshop was a follow-on from that held in 2017 in Sao Paulo entitled “Facilitating the review of new medicines through risk-based evaluations: How can a stratification process be [...]
This Workshop built on previous CIRS global development workshops as well the work being undertaken by various groups in the areas of good regulatory and review practices and focused [...]
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 [...]
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, [...]
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 [...]
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 [...]
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 [...]
Highlights from the workshop entitled 'Regulatory Performance: Critical Success Factors in Today’s Environment', held by the CMR International Institute for Regulatory Science in Washington D.C., 15-16 September 2003 In [...]