This R&D Briefing summarises the outputs of breakout group discussions held during a CIRS multi-stakeholder workshop in December 2020 entitled ‘Reimagining medicine regulatory models: implementing fit-for-purpose sustainable activities for [...]
This workshop was part of a series of workshops on reliance, which continues to be an important area of focus for CIRS. It builds on the outcomes of a [...]
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 [...]
Background: Pharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into [...]
There is a growing interest in aligning accelerated regulatory pathways with flexible access and reimbursement pathways to expedite the equitable availability of high-quality, safe, and effective medicines that provide [...]
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 book compiles the presentations and syndicate discussions from a CIRS workshop that brought together representatives from international pharmaceutical companies and regulatory authorities from Europe, US, Canada and Australia [...]
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 [...]
